[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UNICANCER\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":686},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,46,78,103,135,162,184,211,237,261,285,309,346,374,397,424,455,481,504,532,560,589,613,638,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641210","phase-2-skipping-hormone-therapy-in-low-risk-early-breast-cancer-100641210",false,"NCT07661927","Skipping Hormone Therapy in Low-Risk Early Breast Cancer","No Endocrine Therapy in Small HR⁺\u002FHER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial","NoELA","Inclusion Criteria:\n\n* Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.\n* New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam with no evidence of nodal or distant metastatic disease.\n* Contralateral breast described as BI-RADS (Breast Imaging-Reporting And Data System) 1 or 2 in diagnostic imaging.\n* Negative axillary node involvement by sentinel node biopsy or axillary node dissection (pN0) or Clinically negative axillary node involvement (cN0) after mandatory ultrasound exploration without surgical exploration of the axilla if Breast Conservative Surgery (BCS) was performed.\n* Estrogen Receptor (ER) positive (≥ 50%) and Progesterone Receptor(PR) positive (\\> 20%), Ki67 low (≤15%) and HER2 negative (IHC or In Situ Hybridization approach) according to ASCO (American Society of Clinical Oncology) criteria.\n* Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b.\n* Treated by mastectomy or BCS with microscopically clear resection margins defined as \"no-ink on tumor\" or ≥1 mm for invasive and non-invasive disease or no residual disease on re-excision.\n* If BCS was performed, participants must have received or have scheduled adjuvant local radiotherapy (RT) within 3 months after surgery\n* No indication of adjuvant chemotherapy.\n* The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures.\n* Participants must be affiliated with a Social Security System (or equivalent).\n* The participant must have signed a written informed consent form before any trial-specific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant's consent in writing.\n\nExclusion Criteria:\n\n* Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.\n* Have received or are eligible for adjuvant chemotherapy.\n* Absolute contraindication for RT in case of BCS or patients who were treated with partial breast irradiation.\n* Have been treated with mastectomy and with adjuvant radiotherapy received or scheduled.\n* Invasive lobular breast cancer.\n* Bilateral breast cancer or history of other invasive ipsi- or contralateral breast cancer.\n* Multifocal or multicentric disease.\n* Disease limited to microinvasion only (\\\u003C 1 mm).\n* Evidence of lymphovascular invasion.\n* History of non-breast cancer malignancies if not disease-free for \\> 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin.\n* Non-malignant severe disease associated with a life expectancy \\\u003C 10 years.\n* Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations.\n* Enrolled in another therapeutic study within 30 days prior to inclusion.\n* Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n* Persons deprived of their liberty or under protective custody or guardianship.","FEMALE","60 Years",{"count":21,"type":22},700,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.\n\nAll participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.",[28],"Breast Cancer (Early Breast Cancer)",[30,31,32],"breast cancer","hormone therapy","de-escalation","NOT_YET_RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":22},"2026-06-15",{"date":41,"type":22},"2033-06-15",{"name":43,"class":44},"UNICANCER","OTHER",41,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100614807","phase-3-liver-directed-chemotherapy-after-surgery-of-liver-metastases-of-colorectal-cancer-in-patients-with-high-risk-of-recurrence-of-their-disease-100614807","NCT07284394","Liver-directed Chemotherapy After Surgery of Liver Metastases of Colorectal Cancer in Patients With High Risk of Recurrence of Their Disease","Postoperative Hepatic Arterial Chemotherapy After Resection of Colorectal Liver Metastases in Patients at High Risk of Recurrence","PACHA-02","Inclusion Criteria:\n\n* Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n* Age \\> 18 years\n* ECOG performance status 0-1\n* Histologically confirmed stage IV pMMR CRC\n* Resected CRLM by one- or two-stage procedures including reverse strategy\n* Partial Response or Stability Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +\u002F- targeted agent before surgery\n* Curative-intent ( R0\u002FR1 resection ± local ablation) surgery of 4 or higher CRLM\n* No macroscopic residual (hepatic or extra-hepatic) disease on postoperative CT scan within 4 weeks after surgery confirmed during local multidisciplinary tumor board (except up to 3 lung nodules \\\u003C 10 mm deemed amenable to curative-intent resection\u002Flocal ablation and non-resected primary tumor with no or mild symptoms)\n* Eligible to HAI of oxaliplatin by (permanent or selective) catheterization defined as the absence of medical (any contraindication to oxaliplatin administration, mainly residual peripheral sensory neuropathy grade \\\u003C 2) and technical (vascular anatomy to perform HAI chemotherapy) contraindications to administer oxaliplatin-based doublet or triplet chemotherapy within 8 weeks from surgery during at least 4 cycles evaluated by interventional radiologist and medical oncologist\n* Normal liver function (bilirubin \\\u003C 1.5 x upper limit of normal values (ULN), aminotransferases \\\u003C 5 ULN, alkaline phosphatase \\\u003C 5 ULN, International normalized ratio (INR) \\\u003C 1.5 ULN, platelets \\> 100,000\u002Fmm3)\n* Women of childbearing potential must have a negative pregnancy test done within 30 days before randomisation\n* Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug\n* Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures\n* Patients must be affiliated to a Social Security System (or equivalent)\n\nExclusion Criteria:\n\n* Stage IV dMMR CRC\n* Progressive Disease (RECIST 1.1) to preoperative cytotoxic doublet or triplet IV chemotherapy +\u002F- targeted\n* Incomplete (R2) surgery or residual (hepatic or extrahepatic) disease on postoperative CT scan within 4 weeks after surgery or symptomatic primary tumours in case of reverse strategy\n* Extra hepatic metastasis disease, except ≤ 3 lung nodules \\\u003C 10 mm deemed amenable to curative-intent resection\u002Flocal ablation and non-resected primary tumor with no or mild symptoms\n* Impossibility to receive at least 4 postoperative cycles with oxaliplatin\n* Patients with contraindications for HAI or IV doublet or triplet administration as limiting anatomical variations of hepatic artery, peripheral sensory neuropathy ≥ grade 2 (NCI-CTAE v.5.0), gastric\u002Fduodenal ulcer or significant chronic liver disease (resulting in portal hypertension and\u002For liver failure)\n* Peripheral neuropathy grade ≥ 2\n* Patient with a dihydropyrimidine dehydrogenase deficiency (DPD)\n* Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥5 years\n* Pregnant women or women who are breast-feeding\n* Participation in another therapeutic trial within the 30 days prior to randomisation\n* Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n* Persons deprived of their liberty or under protective custody or guardianship","ALL","18 Years",{"count":57,"type":22},272,[59],"PHASE3","At the time of diagnosis, 25% of patients with colorectal cancer present with liver metastasis (CRLM). Among patients with localized colorectal cancer (Stages I-III), 50% to 70% will develop liver metastases during the course of their disease. Surgery in combination with intravenous (IV) chemotherapy represents the only chance of cure for selected patients by removing all liver metastases and treat residual microscopic disease by postoperative chemotherapy for 3 months. However, up to two-thirds of patients will experience a relapse, with about two-thirds of recurrences occurring in the liver.\n\nHepatic arterial infusion (HAI) chemotherapy has been proposed to improve the efficacy of chemotherapy by increasing the concentration of the drug in the liver. This treatment is currently administered by infusion through a specific catheter placed in the artery feeding the liver parenchyma, connected to a subcutaneous port-a-cath system. Several trials have shown that the administration of floxuridine or oxaliplatin via HAI combined with IV chemotherapy achieves a higher response rate compared to IV chemotherapy alone in patients with unresectable colorectal liver metastases. HAI chemotherapy has thus become an attractive therapeutic option for patients who underwent curative-intent surgery to reduce the risk of hepatic recurrence.\n\nThe investigators recently demonstrated in the PACHA-01 phase II randomized study a 47% decrease of hepatic recurrence risk by HAI of oxaliplatin compared to IV chemotherapy alone, despite a higher but manageable toxicity among 99 patients who underwent curative surgery considered at high risk of recurrence. Moreover, this study showed promising results in terms of time to recurrence and survival. Moreover, feasibility has improved in recent years with the development of non-invasive techniques for HAI.\n\nThe investigators propose to conduct the PACHA-02 trial to evaluate the efficacy in terms of disease-free survival of oxaliplatin administered via HAI in combination with IV chemotherapy after curative resection in patients with colorectal cancer at high risk of recurrence. A total of 272 patients who will undergo curative surgery for at least 4 CRLM with no residual disease on imaging performed within 4 weeks after surgery will be included. Patients will then be randomized to receive oxaliplatin-based chemotherapy either via HAI or IV combined with standard IV chemotherapy, every 2 weeks for at least 3 months.\n\nThe primary objective of this study will be to determine if the administration of oxaliplatin via HAI increases the time between treatment and disease recurrence compared to IV administration. The secondary objectives include overall survival, hepatic recurrence-free survival, safety, pattern of recurrence, and quality of life.",[62,63],"Colorectal Adenocarcinoma Metastatic in the Liver","Colorectal Cancer",[65,66,67,68,69],"hepatic arterial infusion chemotherapy","Colorectal cancer","Colorectal Liver metastases","High risk of recurrence","Surgery","2026-05-22",{"date":72,"type":37},"2026-05-26",{"date":74,"type":22},"2026-07",{"date":76,"type":22},"2035-01",{"name":43,"class":44},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100611182","phase-3-chemotherapy-de-escalation-in-hr--her2--intermediate-risk-early-breast-cancer-treated-with-adjuvant-ribociclib-100611182","NCT07237256","Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib","No Chemotherapy in Intermediate-risk HR+ HER2- Early Breast Cancer Treated With Ribociclib (LEE-011) in the Adjuvant Setting, a Non-inferiority Phase III Trial","NoLEEta","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial-specific screening procedure.\n\n   Note: When the patient is physically unable to give their written consent, an impartial witness of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Patient is ≥ 18 years old.\n3. Patient is female with known menopausal status at the time of randomization.\n\n   Post-menopausal status is defined as:\n   1. Patient underwent bilateral oophorectomy, or\n   2. Age ≥ 60 years, or\n   3. Age \\\u003C 60 years and either amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) or Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.\n   4. If taking tamoxifen or toremifene and age \\\u003C60 years, then FSH and plasma estradiol level in postmenopausal ranges.\n4. The following criteria must be met for histologically confirmed invasive breast carcinoma, as determined by the local pathologist:\n\n   1. Pathological stage (8th edition of the AJCC), including pT2 pN0 Grade 3 or pT2 pN0 Grade 2 with Ki67≥20% or pT0-2 pN1 or pT3-4 pN0\n   2. ER-positive (with tumor cells showing ≥10% ER staining) and HER2-negative according to the most recent ASCO\u002FCAP guidelines.\n\n   Note: Multifocal and multicentric tumors are allowed if they meet the clinical stage II criteria of the 8th Edition of the AJCC. All tumors must be ER-positive and HER2-negative. Patients with bilateral invasive breast cancer (diagnosed simultaneously or within 6 months of each other) are eligible if all lesions tested on both sides are ER+ (ie, ≥10% positive stained cells) and HER2- AND adequate surgery has been performed in both breasts.\n5. Chemotherapy eligible per investigator decision, based on clinicopathological findings or the results of any genomic signature.\n6. Patient has no contraindication for the adjuvant endocrine therapy (ET) or chemotherapy in the trial and is planned to be treated with ET for 5 years (after randomization date) or more.\n7. Curative surgery for the invasive disease must have been performed with negative surgical margins within 12 weeks before randomization. If positive surgical margins, patients are eligible if revision surgery or other adequate local treatment (i.e local radiotherapy) is planned.\n8. Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test (β-hCG) before starting study treatment.\n9. Women of childbearing potential must agree to use one effective form of contraception during trial treatment and up to 21 days after the last dose of study drugs or longer, if required per standard of care;\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to randomization.\n11. Adequate hematological, renal, and hepatic function, as outlined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL\n    2. Platelet count ≥100 x 10⁹\u002FL\n    3. Hemoglobin ≥9 g\u002FdL\n    4. Total bilirubin \\\u003C ULN. Patients with known Gilbert syndrome may be enrolled with total bilirubin ≤3 x ULN or direct bilirubin ≤1.5 x ULN\n    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x ULN\n    6. Serum creatinine ≤1.5 mg\u002FdL or calculated creatinine clearance ≥60 mL\u002Fmin\u002F1.73m² (CKD-EPI equation (2021))\n    7. Potassium, total calcium (corrected for serum albumin), and magnesium should be within institutional normal limits or corrected to within normal limits using supplements before the first dose of study medication.\n12. Standard 12-lead ECG values assessed, as:\n\n    1. QTcF interval (QT interval using Fridericia's correction) at screening \\\u003C 450 milliseconds (msec)\n    2. Resting heart rate 50-100 beats per minute (determined from the ECG)\n13. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n14. Absence of any psychological, familial or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n15. Patients must be affiliated to a Social Security System (or equivalent) based on local regulations.\n\nExclusion Criteria:\n\n1. Patient has received any neoadjuvant chemotherapy since her breast cancer diagnosis or has received any prior CDK4\u002F6 inhibitor.\n2. Breast cancer diagnosed while patient was receiving tamoxifen, raloxifene or aromatase inhibitors (AIs) for reduction in risk (\"chemoprevention\") of breast cancer and\u002For treatment for osteoporosis within the last 2 years prior to randomization.\n3. Patient with a known hypersensitivity to any of the excipients of ribociclib and\u002For ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy or peanut allergy).\n4. Patient with evidence or history of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition), inflammatory breast cancer, breast cancer recurrence (local or distant) or a different primary breast cancer.\n5. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible.\n6. Patients whose breast cancer is considered as endocrine therapy insensitive, as determined by investigator's opinion; this may include (but is not limited to) breast cancer classified as \" basal like \" by molecular signatures (if available in the patient file) and\u002For breast cancer with persistently high proliferation after pre-operative endocrine therapy.\n7. Patient has had major surgery within 14 days prior to study treatment initiation.\n8. Patient has known history of human immunodeficiency virus (HIV) infection (testing is not mandatory) whose antiretroviral therapy (ART) has a known strong CYP3A4 inhibitor with potential for DDI with ribociclib. Patients with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines (FDA Guidance, Uldrick et al. 2017):\n\n   1. CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FµL, AND\n   2. No history of AIDS-defining opportunistic infections within the past 12 months (prophylactic antimicrobials allowed if no drug-drug interactions or overlapping toxicities), AND\n   3. On established ART which is not a strong CYP3A4 inhibitor, for at least 4 weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrolment. Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.\n9. Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory).\n10. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.\n    2. Documented cardiomyopathy.\n    3. Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)\n    4. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n       * Risk factors for Torsades de Pointes (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia.\n       * Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment).\n       * Inability to determine the QTcF interval.\n    5. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block).\n    6. Uncontrolled arterial hypertension with systolic blood pressure \\>160 mmHg.\n11. Presence of any other medical conditions, including respiratory or metabolic dysfunction, physical examination findings, or laboratory results that raise reasonable suspicion of a contraindication to the use of an experimental drug, potential impact on compliance with the study protocol, influence on result interpretation, or increased risk of treatment complications for the patients (such as severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or ulcerative colitis, or a preexisting chronic condition resulting in clinically significant diarrhea).\n12. Previous history of pneumonitis, regardless of cause.\n13. Patient is currently receiving any of the following substances within 7 days before randomization and which cannot be stopped within seven days prior to the start of treatment:\n\n    1. Concomitant medications, herbal supplements, and\u002For fruits (e.g. grapefruit, pummelos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4\u002F5\n    2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5\n    3. Any medication prohibited according to the instructions for goserelin, leuprolide or triptorelin (pre-menopausal patients), anastrozole, exemestane, letrozole, or ribociclib.\n    4. Medications known to have a risk of prolonging the QT interval or causing Torsades de Pointes.\n14. Patient is concurrently using hormone replacement therapy. Estrogen replacement therapy discontinued less than two weeks prior to the start of treatment.\n15. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment, or has not fully recovered from side effects of such treatment.\n\n    Note: The following uses of corticosteroids are permitted: a short duration (\\\u003C5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular).\n16. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years.\n17. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the sponsor is required to establish eligibility.\n18. Inability or unwillingness to swallow oral pills.\n19. Presence of malabsorption syndrome or any other condition that could hinder the absorption of study drugs in the gastrointestinal tract.\n20. Any psychological, familial, sociological, or geographical factors that may impede adherence to the study protocol and follow-up schedule.\n21. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the first 48 months of adjuvant therapy.\n22. Persons deprived of their liberty or under protective custody or guardianship.",{"count":87,"type":22},3902,[59],"The advent of CDK4\u002F6 inhibitors (drugs designed to block the action of CDK4\u002F6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+\u002FHER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ \u002FHER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4\u002F6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.",[91],"Breast Cancer",[93,94],"De-escalation","Chemotherapy","RECRUITING",{"date":72,"type":37},{"date":98,"type":37},"2025-12-18",{"date":100,"type":22},"2037-12-31",{"name":43,"class":44},138,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100556688","blood-biomarkers-based-screening-for-hpv-driven-opc-100556688","NCT06528353","Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC","SCREEN-HPV","Inclusion Criteria:\n\n* Aged ≥50 years from the general population\n* Man\n* No previous history of HPV-driven cancer or head neck cancer\n* Willingness to complete follow up visits\n\nExclusion Criteria:\n\n* Aged \\\u003C 50 years\n* Woman\n* History of HPV-driven cancer or head and neck cancer\n* Psychiatric conditions\n* Inability to complete follow up visits\n* Severe medical condition (life expectancy \\\u003C5 years)\n* Previous prophylactic HPV vaccination",true,"MALE","50 Years",{"count":115,"type":22},10000,[117],"NA","The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and\u002For whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.",[120,121,122],"Head and Neck Squamous Cell Carcinoma","Anal Cancer","Human Papilloma Virus",[124,125,126,127,128],"HPV-induced cancer","Head and Neck Cancers","virology","serology","secondary cancer prevention",{"date":72,"type":37},{"date":131,"type":22},"2026-09",{"date":133,"type":22},"2032-09",{"name":43,"class":44},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100350841","evolution-of-the-therapeutic-care-in-lung-cancer-in-france-since-2015-esme-lc-100350841","NCT03848052","Evolution of the Therapeutic Care in Lung Cancer in France Since 2015 (ESME LC)","Epidemiological Strategy and Medical Economic (ESME) Research Program \u002F Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015","Inclusion criteria :\n\n* Adult (over 18)\n* Treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site\n\nExclusion criteria\n\n\\- None",{"count":143,"type":22},75000,"OBSERVATIONAL","This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).",[147],"Lung Cancer",[149,150,151,152,153],"lung cancer","observational study","survival","real world data","real life setting",{"date":155,"type":37},"2026-05-27",{"date":157,"type":37},"2017-10-02",{"date":159,"type":22},"2026-12-31",{"name":43,"class":44},21,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},"100306904","evolution-of-the-therapeutic-care-in-metastatic-breast-cancer-from-2008-100306904","NCT03275311","Evolution of the Therapeutic Care in Metastatic Breast Cancer From 2008","Epidemiological Strategy and Medical Economic (ESME) Research Program \u002F Academic Real World Database: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008","ESME-MBC","Inclusion criteria :\n\n* 18 years old patient\n* Patient receiving chemotherapy, targeted therapy, immunotherapy, radiation therapy and hormonotherapy in a French Comprehensive Cancer Center.\n\nExclusion criteria : None",{"count":171,"type":22},42000,"The Epidemiological Strategy and Medical Economic (ESME) Breast cancer Database is a multicenter real life database using a retrospective data collection process across 18 French comprehensive cancer centers (FCCC) spread over 20 sites. This database compiles data from patient's electronic medical records (EMR).",[174],"Metastatic Breast Cancer",[176,150,151,152,153],"metastatic breast cancer",{"date":155,"type":37},{"date":179,"type":37},"2014-07",{"date":181,"type":22},"2027-12",{"name":43,"class":44},20,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100620579","phase-2-testing-ivonescimab-in-combination-with-chemotherapy-in-patients-with-metastatic-colorectal-cancers-without-liver-metastases-100620579","NCT07359456","Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases","Randomized Phase 2 Study of Second-line Chemotherapy Comparing FOLFIRI + Ivonescimab Versus FOLFIRI + Bevacizumab in Microsatellite Stable (MSS)\u002F Proficient MisMatch Repair (pMMR) BRAF Wild Type (BRAFwt) Advanced Colorectal Cancer (mCRC) Without Liver Metastases","COLIBRI-GI","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.\n2. Histologically confirmed diagnosis of non resectable pMMR (by IHC) and MSS (by molecular biology) and BRAFwt metastatic colorectal cancer with no liver metastasis.\n3. Must have previously received 1st-line treatment with FOLFOX +\u002F- anti-VEGF (Vascular endothelial growth factor) or EGFR (Epithelial Growth Factor Receptor) therapy (including recurrence within 6 months after adjuvant FOLFOX for localized CRC and adjuvant\u002Fperioperative FOLFOX for mCRC, as well as progressive disease under maintenance treatment for mCRC) OR 1st-line treatment with FOLFIRINOX (Oxaliplatin, Irinotecan, 5FU, Folinic acid) (under the following condition: no progression under triplet-chemotherapy, progression under LV5FU2 (Folinic acid + 5FU) maintenance, irinotecan stopped for at least 3 months for a reason other than progression)\n4. Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Age ≥18 years.\n7. Adequate Organ Function:\n\n   * Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening):\n\n     * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n     * Platelet count ≥ 100 × 109\u002FL\n     * Hemoglobin ≥ 10.0 g\u002FdL\n   * Kidneys:\n\n     * Creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n     * Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g\n   * Liver:\n\n     * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n     * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy, or prophylactic coagulation)\n8. Life expectancy ≥ 3 months\n9. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment (9 months after the last dose of trial treatment). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n10. WOCBP must have a negative serum pregnancy test performed within 3 days before inclusion and a negative urine pregnancy test on the day of first dose, prior to treatment administration.\n11. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures\n12. Affiliation to the Social Security System (or equivalent)\n\nExclusion Criteria:\n\n1. Presence of liver metastases by CT-scan or MRI. Note: Patients with prior definitively treated liver metastases (surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy) are eligible if no evidence of metastatic disease in the liver on subsequent imaging).\n2. History of Gilbert's syndrome\n3. Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin or in situ tumour treated by surgery).\n4. Patients with high microsatellite instability (MSI-H), mismatched repair disease (dMMR) and\u002For BRAF V600E mutated tumor.\n5. Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before treatment start with the exception of alopecia.\n6. Major surgical procedures or serious trauma within 4 weeks prior to randomization, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.\n7. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n   * Clinically significant GI bleeding such as hematochezia or any episodes of melena or documented acute hemoglobin drop of more than 1 gm in 2 weeks prior to randomization\n   * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits according to the medical standard of the enrolling institution.\n8. Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n9. History of major diseases before randomization, specifically:\n\n   * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association (NYHA) classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n   * History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization\n   * History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization\n   * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization\n   * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization\n10. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction.\n11. Ascites requiring paracentesis within last 30 days\n12. Symptomatic central nervous system (CNS) metastases or leptomeningeal disease Note: Asymptomatic patients (previously treated or untreated) in the absence of corticosteroid and anti-epileptic therapy are allowed. CNS metastases must be stable for ≥4 weeks prior to randomization.\n13. Presence of brainstem, meningeal metastases, spinal cord metastases, or compression.\n14. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n15. Prior immunosuppressive therapy: immunosuppressive doses of systemic medications of \\> 10 mg\u002Fday of prednisone or equivalent must be discontinued ≥ 2 weeks before the first dose of study treatment. Short courses of high dose corticosteroids and\u002For continuous low dose of prednisone (\\\u003C 10 mg\u002Fday) are permitted. In addition, inhaled, intranasal, intraocular, and\u002For joint injections of corticosteroids are allowed.\n16. Any prior clinically significant or active autoimmune disease requiring systemic therapy (eg, with disease- modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy or immunomodulatory agents \\[eg, infliximab or IVIG (intravenous immunoglobulin)\\]) within 2 years prior to randomization; however, the following will be allowed:\n\n    o Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n17. Known history of, or any evidence of, interstitial lung disease.\n18. Patient with non-controlled human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) infection (patient with undetectable viral load (HIV RNA PCR) and CD4 (T CD4 lymphocytes) above 350 either spontaneously or on stable anti-viral regimen).\n19. Known human immunodeficiency virus infection with CD4+ T cell counts \\\u003C 350 cells\u002FµL, hepatitis C infection (subjects with hepatitis C who achieve a sustained virologic response following antiviral therapy are permitted), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody who achieve sustained virologic response with antiviral therapy directed at hepatitis B are permitted)\n20. Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).\n21. Known history of hypersensitivity to ivonescimab and to one of the study drugs or one of its excipients\n22. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.\n23. Pregnant or breast-feeding females.\n24. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.\n25. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n26. Individuals deprived of liberty or placed under protective custody or guardianship.",{"count":193,"type":22},130,[25],"The goal of this clinical trial is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR\u002FMSS BRAFwt mCRC patients without liver metastases in terms of PFS. The main questions it aims to answer are:\n\nDoes FOLFIRI + ivonescimab improve progression-free survival compared to FOLFIRI + bevacizumab?\n\nParticipants will:\n\nTake FOLFIRI + ivonescimab or FOLFIRI + bevacizumab every 2 weeks for a maximum of 24 months Visit the clinic once every 2 weeks for checkups and tests, and have imaging done every 8 weeks Complete some quality of life questionnaires every 8 weeks",[197],"Metastatic Colorectal Cancer",[199,200,201],"Metastatic colorectal cancer","ivonescimab","BRAF wild-type","2026-05-18",{"date":204,"type":37},"2026-05-19",{"date":206,"type":22},"2026-08-31",{"date":208,"type":22},"2033-08",{"name":43,"class":44},22,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100619130","phase-2-clinical-trial-evaluating-the-biological-activity-of-a-new-drug-identified-as-prifetrastat-pf-07248144-combined-with-fulvestrant-for-the-treatment-of-patients-with-hormone-receptor-positive-hr-and-her2-negative-her2--breast-cancer-extended-to-other-organs-100619130","NCT07340619","Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.","UNLOCK - EPIBREAST, a Phase II Study of Prifetrastat (PF-07248144), a KAT6 Inhibitor, Plus Fulvestrant for Advanced HR+\u002FHER2- Breast Cancer, With Biomarkers Analyses","EPIBREAST","Inclusion Criteria:\n\nIn order to participate in the trial, all patients must meet all the following criteria:\n\n1. Patient must have signed the written informed consent prior to any study specific screening procedures.\n\n   Note : When the patient is physically unable to give her\u002Fhis written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Adult participants age ≥18 years.\n3. Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer.\n4. Participants must have progressive disease after at least 1 prior line of a CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy received in metastatic setting. Participants must not have received more than 3 prior lines of systemic therapies including up to 2 lines of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting. Note that prior treatment with fulvestrant is permitted.\n5. Participants must have documentation of ER-positive tumor (≥10% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.\n6. Participants must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0\u002F1+ or HER2 2+ and negative by in situ hybridization (FISH\u002FCISH\u002FSISH\u002FDISH) defined as a HER2\u002FCEP17 ratio \\\u003C2 or for single probe assessment a HER2 copy number \\\u003C4.\n7. Female participants with premenopausal status (see section 5.8.4) must be willing to undergo medically induced menopause by treatment with approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause.\n8. Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated.\n9. Participants must present with a metastatic site easily accessible to a biopsy procedure and be a non-bone and non-irradiated site.\n10. ECOG Performance Status PS 0 or 1.\n11. Expected survival of more than 3 months.\n12. Adequate bone marrow function, including:\n\n    1. ANC ≥1,500\u002Fmm3 or ≥1.5 x 109\u002FL;\n    2. Platelets ≥100,000\u002Fmm3 or ≥100 x 109\u002FL;\n    3. Hemoglobin ≥9 g\u002FdL.\n13. Adequate renal function, including serum creatinine ≤1.5 x ULN or estimated creatinine clearance GFR ≥50 mL\u002Fmin as calculated using the method standard for the institution. In equivocal cases, a 24-hour urine collection test can be used to estimate creatinine clearance more accurately.\n14. Adequate liver function, including:\n\n    1. Total serum bilirubin ≤1.5 x ULN unless the participant has documented Gilbert syndrome;\n    2. AST and ALT ≤2.5 x ULN; AST and ALT ≤5.0 x ULN if there is liver involvement.\n15. Adequate blood clotting function: International Normalized Ratio (INR)\u002FProthrombin Time (PT) and either partial thromboplastin Time (PTT) or activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN.\n16. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1 except for AEs not constituting a safety risk by investigator judgment.\n17. Participants must consent to the use of their archived and\u002For collected tumor specimen, as well as blood samples, as detailed in the protocol, for future scientific research which includes, but is not limited to DNA, RNA, and protein-based biomarker detection.\n18. Women of childbearing potential must have a negative serum pregnancy test (with a sensitivity of at least 25 mIU\u002FmL) result within 3 days of enrolment.\n19. Men or women of childbearing potential must agree to the use of effective contraceptive for the study duration and for at least 28 days after the last dose of study treatment for women, and at least 93 days for men.\n20. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n21. . Patients must be affiliated to a Social Security System (or equivalent).\n22. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion criteria:\n\nPatients are not eligible to participate if they meet any of the following criteria:\n\n1. Participants with known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for these metastases for at least 3 weeks and are neurologically stable for 2 months (requires MRI confirmation).\n2. Participants with advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions \\[pleural, pericardial, peritoneal\\], pulmonary lymphangitis, and over 50% liver involvement). Note: Participants with indwelling catheter for drainage, or requirement for drainage no more frequently than once a month will be allowed.\n3. Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. Other indolent cancers that do not interfere with assessment of primary cancer under study may be allowed with prior sponsor approval.\n4. Major surgery within 3 weeks prior to randomization.\n5. Radiation therapy within 3 weeks prior to randomization.\n6. Systemic anti-cancer therapy within 3 weeks prior to randomization. If the last immediate anti-cancer treatment contained an antibody-based agent(s) (approved or investigational), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) prior to receive the study intervention treatment is required.\n7. Prior irradiation to \\>25% of the bone marrow.\n8. Participants with active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, known HIV or AIDS related illness. HIV seropositive subjects who are healthy and low risk for AIDS-related outcomes could be considered eligible.\n\n   Eligibility criteria for HIV-positive subjects should be evaluated and discussed with sponsor's medical monitor and will be based on current and past CD4 and T-cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Also, the potential for drug-drug interactions will be taken into consideration. In equivocal cases, with positive serology, those participants with a negative viral load are potentially eligible provided the other entry criteria are met.\n9. Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor).\n10. Baseline 12 -lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \\>470 msec, complete LBBB, signs of an acute myocardial infarction, ST changes suggestive of active myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \\>470 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF- should be used for decision making and reporting. If QTcF exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer -interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants. Cases must be discussed in detail with sponsor's medical monitor to judge eligibility.\n11. Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, clinically important atrial or ventricular arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), serious conduction system abnormalities (eg, bifascicular block \\[defined as right bundle branch and left anterior or posterior hemiblock\\], 3rd degree AV block), unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and\u002For other clinical significant episode of thrombo embolic disease and ongoing cardiac dysrhythmias of NCI CTCAE ≥Grade 2. For Grade 2 atrial fibrillation, may be considered eligible with sponsor approval (e.g if improved to Grade 1 with non-urgent medical intervention or chronic Grade 2 atrial fibrillation with good rate control with non-urgent medical intervention). If a participant has a cardiac rhythm device\u002Fpacemaker placed and QTcF \\>470 msec, the participant can be considered eligible. Participants with cardiac rhythm device\u002Fpacemaker must be discussed in detail with sponsor's medical monitor to judge eligibility.\n12. Therapeutic anticoagulation.\n13. Hypertension that cannot be controlled by optimal medical therapy (eg, ≥160\u002F100 mmHg).\n14. Participation in other studies involving investigational drug(s) within 3 weeks prior to study entry. Participation in observational or in long term follow-up of other studies is allowed if no procedures which may interfere with the interpretation of study results will be performed.\n15. Known or suspected hypersensitivity or severe allergy to active ingredient\u002Fexcipients of study drug(s) such as lactose.\n16. Prior treatment with prifetrastat. Note that prior treatment with fulvestrant is permitted.\n17. Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of prifetrastat. Gastroesophageal reflux disease under treatment is allowed.\n18. Current use or anticipated need for food or drugs that are known moderate or strong CYP3A4\u002F5 inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A4\u002F5 inhibitor, whichever is longer prior to first dose of study intervention (see Appendix 8 for a list of exemplary strong\u002Fmoderate CYP3A4\u002F5 inhibitors).\n19. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inducers, including their administration within 10 days or 5 half-lives of the CYP3A4\u002F5 inducer, whichever is longer prior to the first dose of study intervention (see Appendix 8 for a list of exemplary strong\u002Fmoderate CYP3A4\u002F5 inducers).\n20. Current use or anticipated need for food or drugs that are known moderate\u002Fstrong CYP2C9 inhibitors, including their administration within \\[10 days or 5 half-lives of the CYP2C9 inhibitor, whichever is longer\\] prior to first dose of investigational product (amiodarone, fluconazole, miconazole, oxandrolone) (see Appendix 8 for a list of exemplary strong\u002Fmoderate CYP2C9 inhibitors).\n21. Current use or anticipated need for drugs that are known moderate\u002Fstrong CYP2C9 inducers, including their administration within \\[10 days or 5 half-lives of the CYP2C9 inducer, whichever is longer\\] prior to the first dose of investigational product (carbamazepine, rifampin) (see Appendix 8 for a list of exemplary strong\u002Fmoderate CY2C9 inducers).\n22. Patient is currently pregnant, breastfeeding, or planning to become pregnant.\n23. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n24. Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n25. Person deprived of their liberty or under protective custody or guardianship.",{"count":220,"type":22},51,[25],"Although treatments for breast cancer have improved, 20-30% of patients with early disease develop metastases (cancer that spreads to other parts of the body). Among the different types of breast cancer, hormone-sensitive cancers that do not overexpress the HER2 protein (HR+\u002FHER2-) are the most common. For patients with this type of cancer, an endocrine treatment such as aromatase inhibitors, tamoxifen or fulvestrant, is often used and may be combined with drugs called CDK4\u002F6 inhibitors, which help improve survival rate. However, when the cancer becomes resistant to these treatments, treatment strategies are more limited\n\nA new drug, prifetrastat (PF-07248144), which targets KAT6 proteins, which play a role in the growth of cancer cells, has shown promising results. Indeed, associated with fulvestrant, it allowed to fight against cancer in some patients who had already received many treatments.\n\nThe UNLOCK-EPIBREAST study aims to investigate whether the combination of prifetrastat plus fulvestrant could offer a new therapeutic option for people with HR+\u002FHER2- metastatic breast cancer who have already received endocrine therapy plus CDK4\u002F6 inhibitors.",[224],"Metastatic (Stage IV) Melanoma",[226,227,228,229,230],"Epiddrug","breast cancer RH+ \u002FHER2-","KAT6 inhibitor","prifetrastat","PF-07248144",{"date":204,"type":37},{"date":202,"type":22},{"date":234,"type":22},"2029-11-18",{"name":43,"class":44},8,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100607374","arm-swelling-occurence-in-breast-cancer-patients-with-nodal-radiotherapy-impact-of-informing-them-of-ai-predicted-risk-100607374","NCT07187726","Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk","Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision","PRE-ACT-01","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures\n2. Women ≥ 18 years\n3. Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +\u002F- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status\n4. Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and\u002For marked lymph node biopsy \\[Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure\u002F (Targeted Axillary Dissection (TAD) procedure\\] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+\u002F- II+\u002F- III+\u002F- IV+\u002F- interpectoral nodes (Rotter) +\u002F- the IMC(Internal Mammary Chain)\n5. ECOG performance status 0-2\n6. Patient must be randomized within the recommended time period from last surgery or the last series of chemotherapy whichever comes last as per national or institutional guidelines in order not to delay radiotherapy treatment start\n7. Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of radiotherapy\n8. Patient is willing and able to comply with the protocol for the duration of the clinical investigation including undergoing treatment and scheduled visits, and examinations including follow-up\n9. Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements\n\nExclusion Criteria:\n\n1. Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast\n2. Bilateral breast cancer\n3. Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin\n4. Patient who has an indication for boost to one or more regional nodes\n5. Previous radiation therapy to the chest region\n6. Patients having arm swelling requiring arm sleeve prescription at baseline\n7. Any condition that prevents the patient from wearing a compression sleeve for 8h\u002Fday from the first day of radiation therapy until 3 months after the initiation of adjuvant radiotherapy\n8. Pregnant or breastfeeding women\n9. Patient already included in another therapeutic study involving radiotherapy dose\u002Fregimen\u002Ftechnique and\u002For arm lymphedema risk\n10. Person deprived of their liberty or under protective custody or guardianship\n11. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",{"count":246,"type":22},724,[117],"Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.\n\nThe goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm lymphedema after breast cancer radiotherapy can help patients and physicians make better treatment decisions.\n\nThis AI tool has been developed to determine each patient's personalized risk of developing lymphedema. The risk is shown using a web app that explains the factors involved and offers suggestions like using a compression sleeve to reduce the risk.\n\nWomen (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of hormone receptor status, tumor grade, or HER2 status.\n\nPatients will be randomly divided into two groups:\n\n* Experimental group: Patients and physicians will see the AI-predicted risk and use it to guide treatment choices.\n* Control group: The risk is not shown.\n\nThe radiotherapy treatment will be exactly the same as the treatment that you would have received if you had not taken part in this clinical investigation. The only intervention will be whether or not the risk you are informed of the risk of developing lymphedema.\n\nAll patients will be followed for two years to monitor:\n\n* How risk communication influences radiotherapy treatment choices\n* The occurrence of side effects\n* The predictive performance of the AI tool\n* Patients' quality of life\n* Compliance with compression sleeve use\n* Loco-regional recurrence-free survival, distant disease-free survival, and overall survival",[250],"Unilateral Breast Neoplasms",[252,253],"Arm lymphedema","Individualized AI-based risk prediction",{"date":204,"type":37},{"date":256,"type":37},"2025-10-07",{"date":258,"type":22},"2029-01-31",{"name":43,"class":44},27,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":45},"100556792","phase-2-testing-ivonescimab-versus-folfox-in-advanced-biliary-tract-cancer-patients-100556792","NCT06529718","Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients","A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1\u002FVEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced\u002FMetastatic Biliary Cancers","SEVILLA","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n2. Histologically-proven intrahepatic cholangiocarcinoma, perihilar \u002F distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded).\n3. Locally advanced (non-resectable) or metastatic disease.\n4. Participated in the Screening phase of the SAFIR-ABC10 trial.\n5. Progression after first line standard of care (1L-SoC) regimen (CISGEM ± immunotherapy) as assessed by the investigator.\n6. Eligible for second-line treatment with FOLFOX.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Presence of at least one evaluable lesion according to RECIST v1.1.\n9. Age ≥18 years.\n10. Adequate bone marrow function: absolute neutrophil count (ANC) ≥2 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL.\n\n    Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening haematology analysis.\n11. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).\n12. Adequate renal function: estimated creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula, or estimated glomerular filtration rate value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g.\n13. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated PTT ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy,or prophylactic coagulation).\n14. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥50% at baseline as determined by either echocardiogram or multigated acquisition (MUGA) scan.\n15. Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests: For patients with active HBV: HBV DNA \\\u003C500 IU\u002Fml during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir). For patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible.\n16. Performance of an esophagogastroduodenoscopy within 6 months of inclusion and assessment and treatment of varices of all sizes per local standard of care prior to randomisation.\n17. Biliary tract obstruction has been relieved.\n18. Adequate biliary drainage, with no evidence of ongoing infection.\n19. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n20. WOCBP must have a negative serum pregnancy test performed within 3 days before randomisation and a negative urine pregnancy test on the day of first dose, prior to treatment administration.\n21. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures.\n22. Affiliated to a social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n\nExclusion Criteria:\n\n1. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before randomisation with the exception of alopecia.\n2. Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment.\n3. Contraindication to ivonescimab.\n4. Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).\n5. Treatment with brivudine, sorivudine or their chemical analogues in the 4 weeks prior to randomisation.\n6. Major surgical procedures or serious trauma within 4 weeks prior to randomisation, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterisation and port implantation) within 3 days prior to randomisation.\n7. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomisation, including but not limited to:\n\n   1. Gastrointestinal bleeding.\n   2. Haemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\n      Note: transient haemoptysis associated with diagnostic bronchoscopy is allowed.\n   3. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed).\n   4. Need for therapeutic anticoagulant therapy within 14 days prior to randomization.\n\n   Note: Prophylactic anticoagulation for deep vein thrombosis or pulmonary embolism or to maintain venous patency is allowed.\n8. Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n9. History of major diseases before randomization, specifically:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia),\n   2. History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomisation,\n   3. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization,\n   4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomisation,\n   5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomisation.\n10. Imaging during the screening period shows that the patient has:\n\n    1. Radiologically documented evidence of major blood vessel invasion or encasement by cancer,\n    2. Radiographic evidence of intra-tumour cavitation.\n11. Microsatellite instability positive disease.\n12. Concurrent malignancy (other than advanced biliary tract cancer), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n13. HIV positive (HIV 1\u002F2 antibodies patients), or a known history of active Tuberculosis bacillus.\n14. Any immunosuppressive therapy (i.e. corticosteroids \\>10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy.\n15. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,\n    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * Rash must cover \\\u003C 10% of body surface area,\n       * Disease is well controlled at baseline and requires only low-potency topical corticosteroids,\n       * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n16. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n17. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.\n18. Pregnant or breast-feeding females.\n19. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.\n20. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n21. Individuals deprived of liberty or placed under protective custody or guardianship.",{"count":270,"type":22},72,[25],"The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.\n\nEligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.",[274],"Biliary Tract Cancer",[276,277,278],"Biliary tract cancer","Gallbladder","Cholangiocarcinoma",{"date":204,"type":37},{"date":281,"type":37},"2025-10-09",{"date":283,"type":22},"2029-01-30",{"name":43,"class":44},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100486572","phase-3-personalized-medicine-for-advanced-biliary-cancer-patients-100486572","NCT05615818","Personalized Medicine for Advanced Biliary Cancer Patients","Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial","SAFIR-ABC10","SCREENING PHASE\n\nInclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures (Consent #1)\n2. Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)\n3. De novo or recurrent, locally advanced (non-resectable) or metastatic disease\n4. Availability of a suitable archived sample of primary or metastatic tumour tissue (frozen, or FFPE) or able to undergo a biopsy to obtain a suitable malignant tissue sample\n5. Aged ≥18 years\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Estimated life expectancy \\>3 months\n8. Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy\n9. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements).\n\nExclusion Criteria:\n\n1. Contraindication to 1L-SoC\n2. Patients who are candidates for locoregional therapy\n3. Contraindication to tumour biopsy in the absence of suitable archived sample of tumour tissue\n4. Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry\n5. Received more than 1 cycle of treatment with 1L-SoC\n6. Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study\n7. Current malignancies (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n8. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol\n9. Women who are pregnant or breast-feeding\n10. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n11. Individuals deprived of liberty or placed under protective custody or guardianship\n\nRANDOMISED TRIAL\n\nInclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures (Consent #2)\n2. Molecular profile showing the tumour harbours at least one targetable molecular alteration with a MTT in the study portfolio (as determined by the trial MTB)\n3. Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a pre-treatment disease evaluation, as assessed by the investigator\n4. ECOG performance status of 0 or 1\n5. Presence of at least one evaluable lesion according to RECIST v1.1, or complete response to 12 weeks 1L-SoC\n6. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL\n7. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumour liver involvement)\n8. Adequate renal function: estimated creatinine clearance ≥ 60 mL\u002Fmin according to the Cockcroft-Gault formula\n9. Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA)\n10. Adequate biliary drainage, with no evidence of ongoing infection\n11. Men, and women of childbearing potential (WOCBP) must agree to use adequate contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n12. Women of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of randomisation\n13. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures\n14. Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements)\n\nExclusion Criteria:\n\n1. Disease progression occurring at any time prior randomisation, or toxicity that led to the discontinuation of the 1L-SoC before 4 full cycles have been delivered\n2. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before randomisation, with the exception of alopecia\n3. Contraindication or known hypersensitivity to the MTT for the molecular alteration found in the patient, or any component in their formulation Note: For patients with multiple target alterations, contraindication to one MTT will not warrant exclusion if MTT to an alternative target is feasible.\n4. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers\n5. Major surgery within 4 weeks of randomisation\n6. Radiotherapy within 7 days of randomisation\n7. Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening).\n8. Clinically significant cardiovascular disease (recent acute myocardial infarction, treated congestive heart failure \\[2 or above on the New York Heart Association functional classification scale\\], recent thromboembolic or cerebrovascular events \\[within 12 weeks, excepted if related to indwelling catheter\\], known prolonged QT syndrome).\n9. Cardiorespiratory pathologies where hyperhydration is contraindicated.\n10. Manifestation of tinnitus and\u002For hearing loss since initiation of cisplatin therapy.\n11. Known leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic responance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms.\n12. Concurrent malignancy (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n13. Concomitant treatment with phenytoin in prophylactic use where this cannot be substituted for another therapy\n14. Known active hepatitis B virus or hepatitis C virus infection or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome\n15. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol\n16. Women who are pregnant or breast-feeding\n17. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable\n18. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n19. Individuals deprived of liberty or placed under protective custody or guardianship\n\nADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs:\n\nPatients assigned to receive oral therapies:\n\n1. Inability or unwillingness to swallow pills\n2. History of malabsorption syndrome or other condition that would interfere with enteral absorption. For example, active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy\n\nFutibatinib:\n\n1. History and\u002For current evidence of any of the following disorders:\n\n   1. Non-tumour related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator\n   2. Ectopic mineralization\u002Fcalcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator\n   3. Retinal or corneal disorder confirmed by retinal\u002Fcorneal examination and considered clinically significant in the opinion of the Investigator\n2. Concomitant treatment with strong CYP3A\u002FP-gp inhibitors or strong or moderate CYP3A\u002FP gp inducers where these cannot be substituted for another therapy.\n\nIvosidenib:\n\n1. Patients with history of torsade de pointes\n2. Concomitant treatment with digoxin where this cannot be substituted for another therapy\n3. Patients with a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increased the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome)\n4. Concomitant treatment with strong CYP3A4 inducers or dabigatran where these cannot be substituted for another therapy\n5. Concomitant treatment with medicinal products known to prolong the QTc interval, or moderate or strong CYP3A4 inhibitors where these cannot be substituted for another therapy\n6. Familial history of sudden death or polymorphic ventricular arrhythmia.\n7. Hypokalemia, hypomagnesemia or hypocalcemia where this cannot be corrected by supplementation\n\nZanidatamab:\n\n1. Treatment with anthracyclines within 90 days before first dose of zanidatamab and\u002For total lifetime load exceeding 360 mg\u002Fm2 Adriamycin® or equivalent\n2. Use of corticosteroids administered at doses equivalent to \\> 15 mg per day of prednisone within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Topical, ocular, intra-articular, intranasal, and\u002For inhalational corticosteroids are permitted\n3. QTcF \\> 470 ms\n4. History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure\n5. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease\n6. Clinically significant infiltrative pulmonary disease not related to lung metastases\n7. A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins\n\nNeratinib \\& trastuzumab:\n\n1. Patients with severe hepatic impairment (Child-Pugh Class C)\n2. Co-administration with the following medical products that are strong inducers of the CYP3A4\u002FP-gp isoform of cytochrome P450, such as carbamazepine, phenytoin (antiepileptics), St John's wort (Hypericum perforatum) or rifampicin (antimycobacterial)\n3. Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities\n4. Hypersensitivity to murine proteins\n5. Current active pneumonitis within 90 days of receiving trastuzumab or a known history of interstitial lung disease\n\nEncorafenib \\& binimetinib:\n\n1. Patients with a history or current evidence of retinal vein occlusion or risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or history of hyperviscosity or hypercoagulability syndrome)\n2. Patients with concurrent neuromuscular disorders associated with elevated creatine phosphokinase (\\>ULN)\n3. Patients with hypokalemia, hypomagnesemia, or hypocalcemia (i.e. Serum potassium, magnesium or calcium \\\u003C lower normal limit)\n4. Patients with a QTcF ≥ 450 msec for men, or ≥ 470 msec for women\n5. Current or expected use of a strong inhibitor of CYP3A4",{"count":294,"type":22},800,[59],"The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.\n\nThe trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.",[298],"Biliary Tract Neoplasms",[298,300,301],"Targeted therapy","Personalised medicine",{"date":204,"type":37},{"date":304,"type":37},"2024-07-18",{"date":306,"type":22},"2028-06",{"name":43,"class":44},69,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":326,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":345},"100581133","phase-2-testing-ivonescimab-in-combination-with-chemotherapy-in-advanced-or-metastatic-gastricgastroesophageal-adenocarcinoma-100581133","NCT06846346","Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric\u002FGastroesophageal Adenocarcinoma","Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients","GRACIE","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.\n2. Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)\n3. Metastatic or locally advanced non resectable (stage IV) disease.\n4. Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Age ≥18 years.\n7. For patients without actionable biomarker (HER2 and Claudin 18.2-negative) except for PD-L1, no prior treatment for advanced disease (cohort 1). For patients with at least one of the following actionable biomarker (PD-L1 CPS≥1, and\u002For HER2-positive, and\u002For Claudin 18.2-positive), who had received only one prior line of treatment for advanced disease (cohort 2).\n8. Adequate hematological function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and hemoglobin ≥9 g\u002FdL. Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening hematology analysis.\n9. Adequate renal function: estimated creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula, or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g.\n10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).\n11. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy).This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n12. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment (120 days after the last dose of ivonescimab). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n13. WOCBP must have a negative serum pregnancy test performed within 3 days before inclusion and a negative urine pregnancy test on the day of first dose, prior to treatment administration.\n14. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures\n15. Affiliation to the Social Security System (or equivalent)\n\nExclusion Criteria:\n\n1. Previous or concurrent cancer that is distinct in primary site or histology from gastroesophageal cancer within 2 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\\].\n2. Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.\n3. Enteral intake \\\u003C 1500 kcal \u002Fd and or a weight loss \\> 15% of total body weight within the 6 months\n4. Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before treatment start with the exception of alopecia.\n5. Major surgical procedures or serious trauma within 4 weeks prior to treatment start, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to treatment start.\n6. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including but not limited to:\n\n   1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n   2. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed),\n   3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to treatment start is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n7. Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n8. History of major diseases before inclusion, specifically:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to inclusion, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia),\n   2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before inclusion,\n   3. History of any grade arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to inclusion,\n   4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before inclusion,\n   5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to inclusion.\n9. Imaging during the screening period shows that the patient has:\n\n   1. Radiologically documented evidence of major blood vessel invasion or encasement by cancer,\n   2. Radiographic evidence of intra-tumor cavitation.\n   3. Evidence of higher bleeding risk on prostheses\n10. Any immunosuppressive therapy during more than 7 days (i.e. corticosteroids \\>10mg or equivalent dose) within 14 days before the planned start of study therapy. Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is not considered as a form of systemic treatment.\n11. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,\n    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    I. Rash must cover \\\u003C 10% of body surface area, II. Disease is well controlled at baseline and requires only low-potency topical corticosteroids, III. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n12. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n13. Known history of, or any evidence of, interstitial lung disease.\n14. Patient with non-controlled human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) infection (patient with undetectable viral load (HIV RNA PCR) and CD4 above 350 either spontaneously or on stable anti-viral regimen).\n15. Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)\n16. In case of planned treatment with fluorouracil, proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).\n17. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.\n18. Pregnant or breast-feeding females.\n19. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.\n20. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n21. Individuals deprived of liberty or placed under protective custody or guardianship",{"count":318,"type":22},88,[25],"The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.",[322,323,324,325],"Metastatic Esophageal Adenocarcinoma","Advanced Esophageal Adenocarcinoma","Metastatic Gastric Adenocarcinoma","Advanced Gastric Adenocarcinoma",[327,328,329,330,331,332,333,334,335,336],"Ivonescimab","Esophageal","Gastric","Adenocarcinoma","Cancer","Metastatic","Advanced","FOLFOX","Irinotecan","Paclitaxel","2026-04-22",{"date":339,"type":37},"2026-04-28",{"date":341,"type":37},"2025-11-20",{"date":343,"type":22},"2028-09",{"name":43,"class":44},4,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":45},"100552612","phase-2-dose-individualization-of-chemotherapy-in-patients-with-gastrointestinal-cancers-lacking-a-specific-liver-enzyme-100552612","NCT06475352","Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme","Dihydropyrimidine Dehydrogenase (DPD) Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers","FUDOSE","Inclusion Criteria:\n\n1. Patients with pre-treatment screening based on \\[U\\] value according to INCa\u002FHAS recommendations.\n2. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2\n3. Fluoropyrimidine-naïve patients with gastrointestinal cancer starting chemotherapy combining fluoropyrimidine (5-FU or capecitabine) and oxaliplatin whatever the context (adjuvant, neoadjuvant, palliative) including the following regimens (the most frequently prescribed in gastrointestinal cancers):\n\n   * biweekly 5-FU and oxaliplatin (FOLFOX) +\u002F- targeted therapy (TT)\n   * three-weekly capecitabine and oxaliplatin (CAPOX) +\u002F- TT\n4. Age ≥ 18 years\n5. Patients eligible for full standard fluoropyrimidine and oxaliplatin doses regardless of DPD deficiency\n6. Adequate bone marrow function (cell blood count (CBC)), estimated glomerular filtration rate (DFG) ≥ 50 ml\u002Fmin, alkaline phosphatase (ALP) \u002F aspartate aminotransferase (ASAT) \u002F alanine aminotransferase (ALAT) ≤ 5 upper limit of normal (ULN), and bilirubin ≤ 50 micromol\u002FL\n7. Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n8. Women of childbearing potential must have a negative serum or urine pregnancy test.\n9. Patients must agree to remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year for the duration of study treatment and within 6 months after completing treatment.\n10. Patients must be affiliated to a Social Security System (or equivalent).\n11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Patients with complete DPD deficiency based on \\[U\\] ≥150 ng\u002FmL\n2. Any prior treatment including a fluoropyrimidine\n3. Patients with any contraindication to treatment with fluoropyrimidine or oxaliplatin regardless of DPD deficiency\n4. Patients not eligible for full standard dose fluoropyrimidine and oxaliplatin for clinical reasons including older age and\u002For comorbidity regardless of a DPD deficiency\n5. Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial\n6. Recent or concomitant treatment with brivudine\n7. Pregnant or breastfeeding woman.\n8. Participation in another therapeutic trial within 30 days prior to inclusion.\n9. Persons deprived of their liberty or under protective custody or guardianship.",{"count":355,"type":22},400,[25],"The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers. The main question it aims to answer is:\n\n\\- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency?\n\nParticipants will:\n\n* Take the treatment with the reduction of dose stated by the protocol\n* Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events",[359,63],"Digestive Cancer",[361,334,362,363,332,364,365,366,331],"Fluoropyrimidine","CAPOX","Adjuvant","Recurrent","Colorectal","digestive",{"date":368,"type":37},"2026-04-23",{"date":370,"type":37},"2025-01-20",{"date":372,"type":22},"2030-01",{"name":43,"class":44},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":112,"minAge":55,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},"100432861","phase-3-adt---darolutamide-in-de-novo-metastatic-prostate-cancer-patients-with-vulnerable-functional-ability-peace6-vulnerable-100432861","NCT04916613","ADT +\u002F- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)","A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +\u002F- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents","GETUG-AFU 40","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate.\n3. Aged ≥18 years old at the time of signing informed consent.\n4. De novo metastatic disease defined by clinical or radiological evidence of metastases.\n\n   Note: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\n   * At least one extra-pelvic lymph node ≥2 cm\n   * At least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\n5. Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.\n6. Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\n\n   1. Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4\u002F5, or;\n   2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3\u002F4, or;\n   3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire, or;\n   4. Body mass index (BMI) ≤21 kg\u002Fm² and\u002For \\>5% weight loss in the last 6 months, or;\n   5. Timed up and go test (TUG) \\>14 sec. Nota Bene: Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable.\n7. Adequate bone marrow function: haemoglobin ≥80 g\u002FL, white blood cells ≥3.0 x10⁹\u002FL and platelets ≥80 x10⁹\u002FL.\n8. Adequate liver function: alanine aminotransferase (ALT) \\\u003C2 x upper limit of normal (ULN) and bilirubin \\\u003C1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT \\\u003C5 x ULN is acceptable.\n9. Adequate renal function: calculated creatinine clearance \\>30 ml\u002Fmin (using the Modification of Diet in Renal Disease \\[MDRD\\] or Chronic Kidney Disease Epidemiology Collaboration \\[CKD EPI) method).\n10. For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\n11. Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n12. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable).\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.\n3. Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \\[BP\\] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart).\n4. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and erectile dysfunction.\n5. Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and\u002For an old-generation AR inhibitor.\n6. Severe or uncontrolled concurrent disease, infection or co-morbidity.\n7. Known hypersensitivity to the study treatment or any of its ingredients.\n8. Major surgery within 28 days before randomisation.\n9. Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.\n10. Prior malignancy ≤3 years before study enrolment. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment.\n11. Inability to swallow oral medications.\n12. Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.\n13. Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.\n14. Treatment with any investigational product within 28 days before randomisation.\n15. Concurrent participation in another clinical trial involving an investigational product (patients enrolled in non-experimental trials with no modification of the standard of care can be included).\n16. Individual deprived of liberty or placed under the authority of a tutor.\n17. Significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition that, in the opinion of the investigator, would preclude participation in this trial.",{"count":383,"type":22},300,[59],"This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +\u002F- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.",[387],"Prostate Cancer Metastatic",[389],"PEACE 6 -Vulnerable",{"date":339,"type":37},{"date":392,"type":37},"2022-04-19",{"date":394,"type":22},"2037-09",{"name":43,"class":44},95,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100611491","spect-ct-guided-elective-contralateral-neck-treatment-in-lateralized-oropharyngeal-cancer-100611491","NCT07241273","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer","SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer: A Phase II Trial","SELECT-FR","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures.\n2. Patients with histologically confirmed T1-T3 M0 lateralized OPC (tonsil, soft palate, pharyngeal wall or base of tongue) not involving or crossing midline. Nodal disease may include no node or single or multiple ipsilateral lymph nodes (largest should be equal or less than 6 cm in maximum diameter) without contralateral nodes involved. For HPV-positive patients, this includes N0-N1. For HPV-negative patients, this includes N0-N2b. Patients with radiologic extranodal extension without clinical signs of extranodal extension (skin invasion, deep nodal fixation, and\u002For clinical signs of cranial nerve or brachial plexus invasion) will be eligible for participation.\n3. HPV-positive or -negative (by p16 immunohistochemistry). Tumours will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.\n4. Planned definitive bilateral neck radiotherapy with or without concurrent chemotherapy.\n5. Patients ≥ 18 years old.\n6. ECOG Performance Status 0-1.\n7. The following radiological investigations must have been done within 8 weeks before randomization:\n\n   * CT or MRI of the neck (with head imaging as indicated);\n   * PET-CT scan;\n   * Chest CT scan.\n8. Patients who receive a concomitant chemoradiotherapy (cCRT) should have adequate organ and bone marrow function including the following:\n\n   * Hematological function (absolute neutrophil count ≥ 1.5 x10⁹\u002FL, platelets ≥ 100 x10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL) measured before cCRT.\n   * Renal function (creatinine clearance ≥ 50 mL\u002Fmin per Cockcroft and Gault formula) measured before cCRT.\n   * Hepatic function (total bilirubin \\\u003C 1.5 ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C 2.5 ULN, Alkaline phosphatase \\\u003C 2.5 ULN) measured before cCRT.\n9. Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method up to 90 days after completing radiotherapy.\n\n   Women of childbearing potential must have a negative pregnancy test before the beginning of the trial.\n10. Treating surgeon must confirm that the patient is a candidate to undergo injection procedure for lymphatic mapping in either the nuclear medicine, ambulatory clinic, or operating room setting.\n11. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n12. Patients affiliated to (or beneficiary from) the French social security system.\n13. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n1. Patients with T1-T2 cancers isolated to the tonsil fossa (i.e., without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \\\u003C 3 cm without extranodal extension.\n2. Patients with tonsil or tongue base primary squamous cell carcinoma who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease are excluded. However, patients who have had previous deep biopsies or partial excisions with clinically evaluable disease are still eligible.\n3. Previous head and neck cancer or multiple synchronous primary head and neck cancers.\n4. Previous induction or neo-adjuvant chemotherapy.\n5. Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are, however, still eligible.\n6. Previous radiotracer allergy. Contraindication in patients with history of hypersensitivity to human albumin-containing products.\n7. Patients with severe, active co-morbidity including any of the following:\n\n   * Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration.\n   * Unstable angina and\u002For congestive heart failure requiring hospitalization within the 30 days of registration.\n   * Acute myocardial infarction within 30 days of study registration.\n   * Diseases precluding RT (e.g., scleroderma).\n8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, as assessed by the investigator.\n9. Pregnant or breastfeeding women.\n10. Patient enrolled in another therapeutic trial within 30 days of registration.\n11. Persons deprived of their liberty or under protective custody or guardianship.",{"count":406,"type":22},128,[117],"Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent chemotherapy for advanced stages. Even though a small proportion of patients with this cancer have involvement of the lymph nodes of the neck on the opposite side of the tumour (contralateral involvement) or involvement of the lymph nodes on both sides of the neck (bilateral involvement), bilateral radiotherapy is performed due to the risk of contralateral microscopic involvement, which is invisible on imaging and clinical examination. Bilateral radiotherapy causes more adverse events, leading to a decrease in quality of life.\n\nLymphatic mapping using Single Photon Emission Computed Tomography-Computed Tomography (SPECT-CT) imaging is a technique that visualises the lymphatic drainage of the tumour and thus determines whether radiotherapy should be delivered unilaterally or bilaterally to the lymph nodes. This technique would therefore reduce adverse events and improve quality of life, while maintaining the efficacy of radiotherapy.\n\nThe goal of the clinical trial SELECT-FR is to investigate if the efficacy of a lymphatic drainage mapping with a SPECT-CT-guided approach is acceptable in terms of two-year Disease Free Survival (DFS) rate in patients with lateralized OPC.",[410,411,412,413,414,125],"Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Cancers","Oropharyngeal Carcinoma","Head and Neck","Head and Neck Cancer","2026-03-23",{"date":417,"type":37},"2026-03-24",{"date":419,"type":22},"2026-04",{"date":421,"type":22},"2031-04",{"name":43,"class":44},12,{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":432,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":442,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},"100601141","phase-3-optimising-adjuvant-chemotherapy-prescription-in-young-patients-with-hormone-dependent-breast-cancer-using-genomic-tests-100601141","NCT07106632","Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests","Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women","OPTIMA-YOUNG","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;\n2. . Premenopausal defined by patient that are not post-menopaused\n3. Female\n4. Age ≥ 35 years\n5. Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative\u002Fnon-amplified ISH) invasive breast cancer; ER and HER2 determination will be assessed according to latest ASCO\u002FCAP or national guidelines;\n6. Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization;\n7. Availability of a Formalin-Fixed Paraffin-Embedded (FFPE) tumour sample from surgery to perform Prosigna® analysis or slides.\n\n   Note: in case of receipt of neoadjuvant endocrine therapy the Prosigna® test must be done on the baseline biopsy. Performing the test on the surgical piece or on on-treatment biopsy is not permitted.\n8. Tumour size and axillary lymph node status. One of the following must apply:\n\n   1. 1-3 lymph nodes involved AND any invasive tumour size.\n   2. node negative (including micrometastases in at least 1 node \\[i.e. deposit \\>0.2-2mm diameter\\]) AND invasive tumour size ≥ 50mm.\n9. Multiple ipsilateral breast cancers are permitted provided that at least one tumour meets the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria.\n10. Bilateral breast cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and\u002For HER2 positive and not clinically significant, defined by both of the following:\n\n    1. The contralateral tumour does not fulfil the tumour size and lymph node eligibility criteria required for trial entry; i.e. the following are not acceptable:\n\n       .i. presence of lymph node macro-metastases; .ii. tumour size ≥50mm when there is no lymph node involvement.\n    2. The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy.\n11. Fitness to receive adjuvant chemotherapy, as judged by the treating physician;\n12. Short term pre-surgical treatment with endocrine therapy, including in combination with non-cytotoxic agents, is allowed providing that the duration of treatment did not exceed 8 weeks;\n13. Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements\n14. Patients must agree to use adequate contraception methods for the duration of study treatment and for the duration specified in the SmPC after completing the treatment, unless agreed with the treatment physician the safety of attempt a pregnancy, which could be possible after at least 18 months of endocrine therapy.\n\nNote : patient with extracapsular nodular transgression are eligible. NOTE: If neoadjuvant endocrine therapy was received, the Prosigna® test must be realized on the baseline biopsy. Performing the test on the surgical specimen or on biopsy taken during treatment is not permitted.\n\nNOTE: Re-excision or complementary mastectomy for close\u002Fpositive surgical margins should be postponed after chemotherapy completion, if chemotherapy is given; breast reconstruction is allowed after trial entry.\n\nNOTE: The use of approved adjuvant targeted agents (abemaciclib, ribociclib and olaparib) combined to adjuvant endocrine therapy is allowed according to local practice recommendations and availability.\n\nExclusion Criteria:\n\n* 1\\. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal:\n\n  1. Age \\>45 and natural amenorrhoea of at least 1 year's duration.\n  2. Bilateral surgical oophorectomy.\n  3. For amenorrhoea not fulfilling the above criteria the diagnosis of postmenopausal status should be supported by hormone measurement: FSH levels must be \\> 25IU\u002FL with low oestradiol (i.e. within the locally defined postmenopausal range), in the event of doubt measured on 2 occasions preferably 4-6 weeks apart. This applies to women who have undergone hysterectomy without bilateral surgical oophorectomy and are age \\\u003C60; those ≥60 may be considered postmenopausal.\n\n     NOTE: Hormonal contraception will suppress FSH and oestradiol levels. In those taking oral contraception, levels will recover rapidly on discontinuation. Depo-Provera injectable contraception lasts many months: all women receiving this agent should be considered premenopausal.\n\n     2\\. Stage IV breast cancer; 3. Start of adjuvant systemic treatment (except for neoadjuvant endocrine therapy for a duration ≤ 8 weeks) before trial entry\\*; 4. Previous diagnosis of malignancy except:\n\n  \u003C!-- -->\n\n  1. Previous ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (LCIS) of the breast managed by local treatment only;\n  2. Previous in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia;\n  3. Previous invasive malignancy managed by local treatment only AND disease-free for at least 10 years.\n\n     5\\. Patients enrolled in another therapeutic trial within 30 days of inclusion; 6. Presence of concomitant medical and\u002For psychiatric comorbidities and\u002For social problems that might prevent informed consent, treatment compliance or follow up; 7. Person deprived of their liberty or under protective custody or guardianship.\n\n     8\\. Pregnant women or women who are breast-feeding at inclusion. 9. Patients unwilling or unable to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures because of geographic, familial, social, or psychological reasons.\n\n     \\*Trial entry is dated from of the date the participant signs the consent form or provides remote verbal consent, whichever is earlier.","35 Years","45 Years",{"count":435,"type":22},3380,[59],"Rationale:\n\nAround 70 to 80% of breast cancers are so-called \"hormone-dependent\" (HR+)\u002FHER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work.\n\nFor post-menopausal women, genetic tests exist to assess whether chemotherapy is really necessary in addition to hormonal treatment. However, for high-risk premenopausal patients, chemotherapy is still systematically recommended, as no study has proved that it can be safely avoided. Clinical trials based on risk stratification using genetic tests have not been conclusive, but the majority of premenopausal women included had not received optimal hormone treatment. It is possible that the beneficial effect of chemotherapy is partly due to the artificial menopause it induces. Some experts believe that, for patients with a high clinical risk but a low genetic risk, an optimised hormonal treatment (drug + OFS) could suffice, without the need for chemotherapy.\n\nObjectives:\n\nMain objective: The aim of the study is to determine whether the use of a genetic test (Prosigna®) to decide whether or not to administer chemotherapy produces results as good as standard treatment (systematic chemotherapy) in premenopausal women with hormone-dependent (HR+) breast cancer\u002FHER2-, by assessing their risk of cancer recurrence.\n\nThe secondary objectives include verifying whether, in patients with a low Prosigna® score (around 70% of cases), optimised hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy combined with hormonal in treatment preventing cancer recurrence. The study also seeks to compare the efficacy of treatment Prosigna®-guided versus systematic chemotherapy in terms of recurrence and quality of life, as well as economic aspects. Finally, the aim is to understand patients' concerns about the concept of reducing treatment (therapeutic de-escalation) and the way in which this information is communicated to them.\n\nThe primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer. This includes the return of cancer in the same breast or neighbouring areas, the spread of cancer to other parts of the body, the appearance of new cancer in the other breast or death from any cause.\n\nTrial Population:\n\nThe study includes women major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer. Patients must have undergone breast and axillary surgery recent and have a tumour sample suitable for analysis by the testProsigna® . They must be able to receive the study treatments Postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment (except short neoadjuvant hormone therapy), women with a recent history of invasive cancer, pregnant women or women who are breast-feeding will not be able to take part in the study.\n\nInterventions:\n\nAfter agreeing to take part, patients will enter the pre-inclusion period (up to 28 days before randomisation), during which the investigator will carry out all the necessary tests to assess their eligibility. The investigator will then randomise the patients to find out which treatment they have been assigned, no more than 2 weeks later: the experimental group will receive a treatment decided on the basis of the results of a genomic test: either chemotherapy and hormone therapy, or hormone therapy alone. The control group will receive the standard treatment. The treatment and follow-up phases are the same as for standard care. Information on the quality of life patient's will and other information (associated costs, perception of their participation in the study, etc.) also be collected by means of questionnaires completed by the patients during the 5 years following randomisation.",[439,440,441],"Early Breast Cancer","Premenopausal Breast Cancer","HR+\u002FHER2- Breast Cancer",[443,444,445,446,447],"Adjuvant therapy de-intensification","Care delivery","Quality of Life","Premenopausal Women","Risk stratification",{"date":417,"type":37},{"date":450,"type":22},"2026-04-01",{"date":452,"type":22},"2038-08-15",{"name":43,"class":44},105,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":111,"sex":18,"minAge":463,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100602175","evaluation-of-an-online-intervention-to-educate-women-at-high-risk-of-breast-cancer-on-how-to-help-reduce-their-risk-100602175","NCT07120087","Evaluation of an Online Intervention to Educate Women at High Risk of Breast Cancer on How to Help Reduce Their Risk.","Evaluation of a Virtual Risk-reduction Intervention Among Women at Higher Than Average Risk of Breast Cancer in the European MyPeBS Screening Trial","MyPREV","Inclusion Criteria:\n\n1. Female (whether born female or not)\n2. Women aged 40 to 74 years (inclusive)\n3. Women who have participated in, or are participating in the MyPeBS study and who fulfilled all the inclusion and non-inclusion criteria for the MyPeBS study.\n4. Women able to express their non-opposition to participate in the intervention\n5. Women who were assessed as being at high (≥≥1.67% - 5.9%) or very high (≥≥6%) risk of invasive breast cancer at 5 years in the MyPeBS study\n\nExclusion Criteria:\n\n1\\. Women who developed a breast cancer during their follow-up in the MyPeBS study","40 Years","74 Years",{"count":466,"type":22},1508,[117],"Breast cancer remains the most common cancer among women and a major cause of death despite advances in screening and treatment. Current screening programs are not personalized and are experiencing declining participation. A promising strategy for breast cancer control would be to implement risk-based prevention and early screening, targeting individuals at high risk of developing breast cancer, in order to improve chances of cure and reduce the need for more intensive treatments. The MyPeBS study was designed to assess whether personalized breast cancer screening (based on an individual's risk of developing breast cancer) is as effective as, or more effective than, current standard screening.\n\nLifestyle interventions involving changes in diet or physical activity, for example, have been shown to be effective in reducing the risk of developing breast cancer, whether low or high. The MyPeBS study evaluates personalized screening but offers limited information on breast cancer prevention. MyPREV is a project that aims to assess the feasibility and impact of a personalized online program on breast cancer risk reduction measures. This program is offered to women at high risk of developing breast cancer as part of the European MyPeBS screening study.\n\nThe main objective is to evaluate adherence to a personalized, online breast cancer prevention program focused on lifestyle and its acceptance among women at high or very high risk of developing cancer who participated in the MyPeBS study.",[91],[471],"Prevent and treat - breast cancer screening","2026-02-24",{"date":474,"type":37},"2026-02-27",{"date":476,"type":37},"2026-02-19",{"date":478,"type":22},"2027-06",{"name":43,"class":44},3,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":501,"leadSponsor":503,"locationsCount":210},"100626565","phase-2-testing-mitazalimab-in-combination-with-standard-chemotherapy-in-immunotherapy-resistant-advanced-biliary-tract-cancers-100626565","NCT07437287","Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers","Countering Immunotherapy Resistance With Novel Combinations in Advanced Biliary Tract Cancers","CROCOBIL","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Histologically-proven intrahepatic cholangiocarcinoma, extrahepatic (perihilar\u002Fdistal) cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)\n3. Measurable tumor according to RECIST v1.1 classification\n4. Non-resectable or metastatic disease or recurrent after surgery (if recurrence more than 6 months after adjuvant treatment stop)\n5. Participants having received a standard first-line treatment (CISGEM + durvalumab or pembrolizumab) and eligible for second- or third-line treatment with FOLFOX. Participant could have received a previous targeted therapy in case of targetable alteration, but only one line of chemotherapy is permitted.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate bone marrow reserve, normal renal and liver functions:\n\n   * Neutrophil count ≥ 1500\u002Fmm³\n   * Platelet count ≥ 150 000\u002Fmm³\n   * Hemoglobin ≥ 10 g\u002Fdl\n   * Estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n   * Total bilirubin \\\u003C 1.5 x ULN (after biliary stent placement in case of biliary obstruction)\n8. No dihydropyrimidine dehydrogenase deficiency, as assessed by pre-treatment uracil blood level ≤ 16 ng\u002FmL\n9. Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization.\n10. Participants must agree to use adequate contraception methods for the duration of study treatment and for within 15 months for women and 12 months for men after completing treatment.\n11. Participants must be affiliated to a Social Security System (or equivalent).\n12. Participant must have signed a written informed consent prior to any trial specific procedures. When the participant is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the participant's consent.\n13. Participants must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n14. Have archival tumor tissue sample that has been identified and confirmed as available\n15. Participant having consented for a new tumor biopsy at inclusion for ancillary studies (participants with non-contributory new biopsy may still be included in the study).\n\nExclusion Criteria:\n\n1. Participants having received previous treatment with fluoropyrimidine, oxaliplatin or CD40 agonist, except for capecitabine given as adjuvant treatment (if last administered \\> 6 months).\n2. Concurrent malignancy (other than BTC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 3 years or more and are deemed at negligible risk for recurrence, are eligible for the trial\n3. Known CNS metastases or carcinomatous meningitis\n4. History of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n5. History of myocardial infarction within 12 months of the first administration of mitazalimab, uncontrolled angina pectoris, unstable cardiac arrhythmias, or congestive heart failure of New York Heart Association class II or greater\n6. QTc \\>450 msec\n7. Known history of HIV, hepatitis B or active hepatitis C infection\n8. Toxicities from first-line treatment not resolved to Grade ≤ 1 (according to NCI-CTCAE v6.0) before randomization with the exception of alopecia\n9. Contraindication to mitazalimab or to FOLFOX regimen, or their excipients\n10. Prior toxicities of grade ≥ 3 with durvalumab or pembrolizumab (except from vitiligo, alopecia, hypothyroidism, adrenal insufficiency and diabetes) or other immune-related toxicities that led to definitive discontinuation\n11. Has received attenuated vaccine within 28 days before the first dose of study treatment\n12. Any condition which in the Investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol (including uncontrolled comorbidities, active infections or untreated central nervous system metastases)\n13. Participation in another therapeutic trial within the 30 days prior to randomization\n14. Pregnant women or women who are breast-feeding\n15. Participant unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n16. Individual deprived of liberty or placed under protective custody or guardianship.",{"count":490,"type":22},160,[25,59],"The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.\n\nThe main questions it aims to answer are:\n\n* Does the addition of Mitazalimab enhance efficacy?\n* What medical problems do participants have when taking Mitazalimab + mFOLFOX?\n\nParticipants will:\n\n* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle.\n* Visit the clinic once every 2 weeks for checkups and tests\n* Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.",[494],"Biliary Tract Cancer (BTC)",[274,496,497],"Mitazalimab","Resistance to immunotherapy","2026-02-20",{"date":474,"type":37},{"date":74,"type":22},{"date":502,"type":22},"2031-10",{"name":43,"class":44},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":54,"minAge":512,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100626087","phase-2-immunotherapy-master-trial-for-advanced-cancers-100626087","NCT07431073","Immunotherapy Master Trial for Advanced Cancers","Adaptive Master Trial for Advanced Cancers With Rapid Evaluation of Molecular & Immune Status for Stratified Immunotherapies in Oncology","METAREM","Inclusion Criteria:\n\n1. Age ≥12 years with at least 40kg body weight or otherwise as per specified in sub-protocol.\n2. Prior to the inclusion in the METAREM master protocol, patients must have signed a written informed consent to baseline PORTRAIT evaluation and on-treatment PORTRAIT evaluation.\n\n   Note:\n   1. When the patient is physically unable to give his\u002Fher written consent, an impartial witness a trusted person of his\u002Fher choice, independent from the investigators or the sponsor, can confirm in signing the patient's consent.\n   2. For patients aged between \\> 12 and \\\u003C 18, specific consent from legal tutors should be obtained on top of the minor consent and prior procedures.\n3. Patients with advanced cancer, as defined as unresectable locally advanced malignancies or metastatic cancers (including leukemias and lymphomas).\n4. Having measurable disease (i.e one measurable lesion according to RECIST v1.1 for solid tumors or one consensus method of blast quantification \u002F minimal residual disease assessment for leukemias).\n5. Eastern cooperative oncology group (ECOG) performance status between 0 and 2.\n6. Patients amenable to undergo a blood draw procedure and a tumor biopsy procedure. For patients with more than 10% malignant cells in their bone marrow or blood, a bone marrow aspirate or blood draw could replace the tumor biopsy.\n7. Adequate organ function as defined by the following criteria:\n\n   * Total bilirubin ≤1.5 ULN, or ≤3.0 ULN in participants with Hepato-Cellular Carcinoma (HCC) or known Gilbert's syndrome if the increase is predominantly due to unconjugated bilirubin.\n   * ALT ≤ 3 x ULN; if liver metastases ALT ≤ 5 x ULN\n   * Absolute Neutrophils count (ANC) ≥ 1000 cells\u002Fmm³ in the absence of G-CSF or GM-CSF within ≤2 weeks before the first dose of study treatment.\n   * Platelets ≥100 000 cells\u002Fmm³\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Albumin ≥ 30 g\u002FL\n   * Calculated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2\n8. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment.\n9. Both sexually active WOCBP and males (and their WOCBP partners) patients must agree to use two methods of effective contraception, one of them being a physical barrier method, or to abstain from sexual activity during the study and for the period indicated in specific sub-protocol after the last study drug administration.\n10. Patient affiliated to the French social security regimen.\n11. Patients with mental and legal ability to fully consent for undergoing the exploratory procedures (blood draws and biopsies) prior (at baseline PORTRAIT) and upon treatment and (on-treatment PORTRAIT).\n12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Any life-threatening allergy to one of the experimental products tested in the sub-protocol where the patient is eligible. In case of allergy to contrast media, patient monitoring should be performed with alternate methods (both CT-scan or MRI).\n2. History of life threatening autoimmune\u002Fimmune mediated inflammatory disease, including but not limited to severe colitis, pneumonitis, Guillain-Barré syndrome, anti-phospholipid syndromes and myocarditis. Patients with a history of auto-immune endocrinopathy (hypo\u002Fhyper thyroiditis, type 1 diabetes mellitus, …) and who are stable on hormone replacement therapy are eligible for the study. Patients with a history of vitiligo, alopecia areata, cutaneous psoriasis and grade 1-2 Sjogren syndrome are eligible.\n3. Treatment with systemic long-term immunosuppressive medications unless otherwise specified in the specific therapeutic sub-protocols. Those immunosuppressive drugs must have been stopped at least 4 weeks prior to enrollment. Hormone replacement therapy with physiological doses of hydrocortisone is acceptable.\n4. Chemotherapy, hormonotherapy, radiotherapy or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks or 5 half-life times (whatever the shortest) prior to treatment with the trial drugs.\n5. Administration of a live, attenuated vaccine within 4 weeks before registration.\n6. Radiotherapy to the chosen RECIST target lesion(s) (unless a progression after radiotherapy has been documented).\n7. Persistence of a clinically relevant treatment-related toxicity from previous chemotherapy, targeted therapy and\u002For radiotherapy which could hamper the safety or efficacy assessment of the therapy tested (for previous disease).\n8. Patients with symptomatic brain metastases or leptomeningeal disease are excluded unless otherwise specified by a specific therapeutic sub-protocol. Clinically asymptomatic brain metastases and clinically asymptomatic leptomeningeal disease are allowed (treatment with steroids prior to initiation of the trial is not allowed).\n9. Patients with evolving tumors next to cavitary or major blood vessels at high risk of massive bleeding and\u002For perforation.\n10. History of clinically significant hemoptysis within the past 3 months.\n11. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial.\n12. Major injuries and\u002For surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and\u002For planned major surgery during the on-treatment study period.\n13. History of clinically significant hemorrhagic or thromboembolic event in the past 3 months.\n14. History of significant cardiovascular diseases (i.e., supraventricular tachycardia, uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure \\> NYHA II, serious cardiac arrhythmia, pericardial effusion).\n15. Ongoing uncontrolled endocrinopathy. Ancient endocrinopathy currently stable with substitutive therapy should not be excluded from the trial.\n16. Other malignancies within the past 5 years other than superficial malignancies (e.g localized squamous or basal cell skin cancer) or carcinoma in situ (e.g cervix, breast, prostate, bladder) which have undergone curative therapies. A history of more than 3 years without subsequent relapse of local prostate cancer treated by surgery and without PSA elevation since surgery, or local breast carcinoma treated by surgery without relapse or resected non-muscle invasive bladder cancers are eligible.\n17. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. A wash out of more than 3 weeks is required after last systemic antibiotics to allow reconstitution of the microbiome. Patients infected by HIV but having efficient anti-retroviral therapy and CD4+ T-cell counts \\>500\u002Fmm³ are eligible. Patients with a history of HBV or HCV that are cured and have eligible liver function criteria are also eligible.\n18. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug in case an oral drug is tested in the sub-protocol for which the patient is screened.\n19. Pregnancy or breast feeding.\n20. Intake of Ganoderma Lucidum mushroom (also called \"Reishi\") and\u002For herbal remedies and\u002For traditional medicines within the past weeks prior to start of study treatment or concomitantly with the trial because of their potential to increase treatment related adverse events.\n21. Any psychological, familial, sociological, geographical factors, lifestyle, behavior, clinical or biological parameters or elements in the past medical history of the patients that, according to the investigator, could preclude the ability of the trial to directly reach its objectives, or indirectly via treatment observance or study follow up. Patients with active alcoholism and\u002For drug abuse are excluded.\n22. Person deprived of their liberty or under protective custody or guardianship.","12 Years",{"count":514,"type":22},275,[25],"Over the past decade, cancer immunotherapy has profoundly transformed oncology by harnessing the patient's immune system to target tumors. These therapies have demonstrated the potential for durable responses and, in some cases, long-term remission or cure. However, despite these advances, only approximately 20-30% of patients derive significant clinical benefit from current immunotherapies. In parallel, investment in oncology drug development continues to grow, with global spending projected to reach $307 billion by 2026. Yet, the overall failure rate in oncology drug development remains extremely high, at around 95%, highlighting a critical gap between scientific innovation and clinical success.\n\nOne major contributor to these failures lies in traditional drug development and regulatory paradigms, which have historically relied on cancer histology as the primary framework for patient selection and treatment evaluation. This approach is based on the flawed assumption that tumors of the same histological type share similar biological behavior and therapeutic vulnerabilities, and that localized and advanced disease are biologically comparable. In reality, tumor biology-rather than histology-plays a decisive role in determining immunotherapy efficacy. Substantial heterogeneity exists within the same cancer type, leading to widely variable patient outcomes even among individuals receiving identical treatments.\n\nThe recent emergence of tumor-agnostic approvals for immunotherapies has reinforced the importance of shared biological features across cancer types. Approvals of anti-PD-1 therapies for microsatellite instability-high (MSI-H), mismatch repair-deficient (dMMR), or tumor mutational burden-high (TMB-H) cancers have demonstrated that biological characteristics can transcend tissue of origin. However, the predictive value of current companion diagnostic assays remains limited. Only 30-40% of biomarker-positive patients respond to treatment, underscoring the inadequacy of existing patient selection strategies.\n\nThese limitations are partly driven by the methodologies used in industry-sponsored clinical trials, which typically rely on tumor samples processed by contract research organizations (CROs). For logistical reasons, analyses are performed on formalin-fixed paraffin-embedded (FFPE) or frozen tissues using conventional techniques such as immunohistochemistry (IHC) and DNA\u002FRNA sequencing. While informative, these methods are often slow, complex, and insufficiently sensitive or specific to guide timely treatment decisions, particularly when results are required within the 3-4 week window following trial consent. Moreover, they offer limited insight into dynamic parameters such as target expression, saturation, and engagement during treatment.\n\nThere is therefore a pressing need for innovative oncology drug development strategies that prioritize biologically driven patient selection, support tumor-agnostic approaches, and enable truly personalized cancer therapy. Addressing this need requires technologies capable of rapid, comprehensive, and functional immune and tumor profiling.\n\nMETAREM is part of the broader REMISSION program, which aims to improve treatment stratification and generate early clinical evidence to support the development of novel therapies and patient selection strategies. METAREM is a master protocol designed to test innovative treatment approaches through dedicated sub-protocols in patients with unresectable locally advanced or metastatic cancers. All patients enrolled in METAREM undergo in-depth immuno-biological characterization at both tumor and blood levels using the PORTRAIT immunoprofiling platform.\n\nPORTRAIT analysis is performed on fresh whole blood and fresh tumor biopsies, enabling rapid, sensitive, and highly specific profiling of each patient's immune and tumor biology. This real-time approach overcomes the limitations of conventional tissue-based assays and allows for a comprehensive understanding of disease mechanisms at the individual level. By integrating these data, METAREM aims to stratify patients into the most appropriate therapeutic sub-protocols, thereby advancing personalized cancer treatment and supporting more efficient, biology-driven drug development.",[518,519],"Advanced \u002F Metastatic Solid Tumors","Advanced Malignancy",[521,522,523,524,525,526],"Advanced Cancers","Metastatic tumors","Immunotherapy","Personalized therapy","Tumor Biology","Tumor Microenvironment",{"date":472,"type":37},{"date":419,"type":22},{"date":530,"type":22},"2034-01",{"name":43,"class":44},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":557,"leadSponsor":559,"locationsCount":4},"100620678","phase-2-immunotherapy-without-chemotherapy-for-advanced-lung-cancer-patients-with-high-pd-l1-levels-100620678","NCT07360743","Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels","Anti-PD1 Monotherapy in 1L Advanced NSCLC Patients With PD-L1 TPS > 50% and PTI=0","META-1","Inclusion Criteria:\n\nIn addition to the inclusion criteria of the METAREM master protocol, following additional criteria must be respected during patient inclusion in META-1 trial:\n\n1. Patients with age ≥18 years\n2. Patients in first-line therapy for advanced metastatic NSCLC with PD-L1 Tumor Proportion Score (TPS) \\>50%, without EGFR\u002F ALK\u002F ROS1 mutations and irrespective of their histological subtype (squamous or non-squamous).\n3. Patients with a PTI score of zero in plasma on the baseline PORTRAIT report. Note: Patients with PTI score ≥ 1 who meet all other criteria will be followed up to 36 months or death according to standard of care.\n\nExclusion Criteria:\n\nIn addition to the Exclusion criteria of the METAREM master protocol, following additional criteria must be considered during patient exclusion from META-1 trial:\n\n1. Patients who have previously received an anti-PD(L)1 or anti-CTLA4 or anti-LAG-3 or anti-TIM3 immunotherapy.\n2. Patients with any Hypersensitivity to the active ingredient or to any of the excipients of Pembrolizumab or Cemiplimab.",{"count":514,"type":22},[25],"Anti-PD-1 monotherapy has demonstrated significant clinical efficacy in advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score \\[TPS\\] \\>50%), outperforming platinum-based chemotherapy in terms of objective response rate (ORR) and overall survival (OS). Pivotal randomized trials such as KEYNOTE-024 and EMPOWER-Lung 1 established the superiority of PD-1 blockade in this patient population, leading to regulatory approvals by both the FDA and EMA for first-line treatment. These studies confirmed that a subset of patients can achieve deep and durable responses with immunotherapy alone, highlighting the potential of immune checkpoint inhibition to provide long-term clinical benefit without the toxicities associated with cytotoxic chemotherapy.\n\nDespite these successes, accumulating clinical evidence has revealed a clinically significant risk of hyperprogressive disease (HPD) in a subset of patients treated with anti-PD-1 monotherapy. HPD is characterized by an unexpected and rapid acceleration of tumor growth following treatment initiation and is associated with early clinical deterioration and increased mortality. This phenomenon likely contributes to the early crossover of survival curves frequently observed when comparing immunotherapy alone with chemotherapy in first-line NSCLC trials. In contrast, such early survival crossover is not observed in trials comparing chemotherapy-immunotherapy combinations with chemotherapy alone, including CheckMate-227, CheckMate-9LA, KEYNOTE-189, and KEYNOTE-407. These results have led many thoracic oncologists to favor combined chemo-immunotherapy regimens as first-line treatment, as they reduce the risk of HPD and increase initial ORR.\n\nHowever, while chemotherapy combined with immunotherapy effectively mitigates the risk of hyperprogression and improves early response rates, it also appears to compromise the durability of antitumor immune responses. Clinical data indicate that the median duration of response with chemo-immunotherapy combinations is approximately 10-11 months, compared with more than 22 months for anti-PD-1 monotherapy alone. This difference is likely attributable to the cytotoxic effects of chemotherapy on immune effector cells, which may limit the persistence and depth of immune-mediated tumor control. Consequently, there remains a strong clinical need to identify patients who could safely and effectively benefit from anti-PD-1 monotherapy while avoiding unnecessary exposure to chemotherapy.\n\nMultiple early-phase translational studies have independently identified soluble plasma biomarkers associated with response or resistance to PD-1 blockade in advanced NSCLC. Building on this body of evidence, translational analyses conducted at Gustave Roussy Cancer Center have identified a composite signature of circulating soluble factors, including interleukin-6 (IL-6), interleukin-8 (IL-8), soluble CD14 (sCD14), soluble CD25 (sCD25), and growth differentiation factor-15 (GDF-15). Together, these biomarkers define a Pro-Tumoral Inflammation (PTI) signature that is strongly associated with primary resistance to anti-PD-1 monotherapy. Elevated PTI scores reflect a systemic inflammatory state that promotes tumor progression and immune dysfunction, and have been linked to poor clinical outcomes, including non-response and hyperprogressive disease.\n\nWithin the META-1 sub-protocol of the METAREM master protocol, the investigators propose to integrate these soluble biomarkers into a single PTI score generated through baseline PORTRAIT immunoprofiling. The primary objective of this approach is to prospectively validate the predictive value of the PTI score for anti-PD-1 monotherapy efficacy in advanced NSCLC. By enabling early identification of patients at high risk of resistance or hyperprogression, this strategy aims to refine patient stratification and guide first-line treatment selection. Ultimately, the use of the PTI score could allow clinicians to identify patients most likely to benefit from anti-PD-1 monotherapy, preserving the potential for durable responses while sparing others from ineffective treatment and optimizing the overall therapeutic strategy in advanced NSCLC.",[544],"Non Small Cell Lung Cancer (Squamous or Non Squamous)",[546,547,548,549,550,551,552],"anti-PD1 monotherapy","non-small cell lung cancer (NSCLC)","Tumor Proportion Score (TPS) >50%","without EGFR\u002F ALK\u002F ROS1 mutations","Pro-tumoral inflammatory score (PTI)","Advanced metastatic cancers","Personalized immunotherapy","2026-02-06",{"date":555,"type":37},"2026-02-10",{"date":419,"type":22},{"date":558,"type":22},"2032-04",{"name":43,"class":44},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":575,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":588},"100610671","phase-2-neo-adjuvant-immunotherapy-in-patients-with-localized-melanoma-100610671","NCT07230613","Neo-adjuvant Immunotherapy in Patients With Localized Melanoma","Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma","NEOREM-NEO-1","In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial:\n\nInclusion Criteria:\n\n1. Patients ≥ 18 years old.\n2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.\n3. Patients who received anti-PD-1 and stopped treatment \\> 6 months prior to their inclusion in NEO-1 trial are eligible.\n4. Patients who received target therapy and stopped treatment \\> 3 months prior to their inclusion in NEO-1 trial are eligible.\n\nExclusion Criteria:\n\n1. Patients with clinically or radiologically detectable distant metastases.\n2. Patients with uveal melanoma.\n3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and\u002F ipilimumab.\n4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.",{"count":569,"type":22},50,[25],"The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy.\n\nIn patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination.\n\nThe NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose\u002Fefficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients.\n\nBaseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.",[573,574],"Cutaneous Melanoma, Stage III","Mucosal Melanoma",[576,577,578,579,580],"Neo-adjuvant Immunotherapy","Localized Cancers","Intra-tumoral treatment","Melanoma","Immune-checkpoint blockade",{"date":582,"type":37},"2026-02-11",{"date":584,"type":37},"2026-01-12",{"date":586,"type":22},"2033-12",{"name":43,"class":44},1,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":54,"minAge":512,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":588},"100613123","phase-2-neo-adjuvant-immunotherapy-master-trial-for-localized-cancers-100613123","NCT07262489","Neo-adjuvant Immunotherapy Master Trial for Localized Cancers","Neo-adjuvant Adaptive Master Trial for Localized Cancers With Rapid Evaluation of Molecular & Immune Status for Stratified Immunotherapies in Oncology","NEOREM","Inclusion Criteria:\n\n1. Age≥ 12 years with at least 40kg body weight or otherwise as per specified in sub-protocol.\n2. Prior to the inclusion in the NEOREM master protocol, patients must have signed a written informed consent to baseline PORTRAIT profiling.\n\n   Note:\n   * When the patient is physically unable to give his\u002Fher written consent, a trusted person of his\u002Fher choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent.\n   * For patients aged between \\> 12 and \\\u003C 18, specific consent from legal tutors should be obtained on top of the minor consent and prior procedures.\n3. Localized solid malignancy that is eligible to receive neo-adjuvant therapy and has medical unmet needs related to disease-free survival, overall survival or quality of life.\n\n   Note: Specific sub-protocols could enroll patients with inoperable tumors with the aim of downstaging them to become operable.\n4. Having a measurable disease (i.e. at least one measurable lesion according to RECIST v1.1 for solid tumors.\n5. Eastern cooperative oncology group (ECOG) performance status between 0 and 2.\n6. Patients amenable to undergo blood draw and tumor biopsy procedures.\n7. Adequate organ function as defined by the following criteria:\n\n   * Total bilirubin ≤1.5 ULN, or ≤3.0 ULN in participants with Hepato-Cellular Carcinoma (HCC) or known Gilbert's syndrome if the increase is predominantly due to unconjugated bilirubin.\n   * ALT ≤ 3 x ULN; if liver metastases ALT ≤ 5 x ULN\n   * Absolute Neutrophils count (ANC) ≥ 1000 cells\u002Fmm³ in the absence of G-CSF or GM-CSF within ≤2 weeks before the first dose of trial treatment.\n   * Platelets ≥100 000 cells\u002Fmm³\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Albumin ≥ 30 g\u002FL\n   * Calculated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2\n8. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment.\n9. Both sexually active WOCBP and male (and their WOCBP partners) patients must agree to use two methods of effective contraception, one of them being a physical barrier method, or to abstain from sexual activity during the study and for the period indicated in specific sub-protocol after the last study drug administration.\n10. Patient affiliated to the French social security regimen.\n11. Patients with mental and legal ability to fully consent for undergoing the exploratory procedures (blood draws and biopsies) prior and upon treatment (at baseline PORTRAIT and once on-treatment PORTRAIT).\n12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Cancer patients with advanced stages and\u002For distant metastasis (unless curable oligometastatic disease). Some sub-protocols could enroll patients with loco-regional (N+) stages amenable to curative intention strategies.\n2. Any life-threatening allergy to one of the experimental products tested in the sub-protocol where the patient is eligible. In case of allergy to contrast media, patient monitoring should be performed with alternate methods (both CT-scan or MRI).\n3. History of life threatening autoimmune\u002Fimmune mediated inflammatory disease, including but not limited to severe colitis, pneumonitis, Guillain-Barré syndrome, anti-phospholipid syndromes and myocarditis. Patients with a history of auto-immune endocrinopathy (hypo\u002Fhyper thyroiditis, type 1 diabetes mellitus, …) and who are stable on hormone replacement therapy are eligible for the study. Patients with a history of vitiligo, alopecia areata, cutaneous psoriasis and grade 1-2 Sjogren syndrome are eligible.\n4. Treatment with systemic long-term immunosuppressive medications unless otherwise specified in the specific therapeutic sub-protocols. Those immunosuppressive drugs must have been stopped at least 4 weeks prior to enrolment. Hormone replacement therapy with physiological doses of hydrocortisone is acceptable.\n5. Chemotherapy, hormonotherapy, radiotherapy or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks or 5 half-life times (whatever the shortest) prior to treatment with the trial drugs.\n6. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment.\n7. Radiotherapy to the chosen RECIST target lesion(s) (unless a progression after radiotherapy has been documented).\n8. Persistence of a clinically relevant treatment-related toxicity from previous chemotherapy, targeted therapy and\u002For local treatments which could hamper the safety or efficacy assessment of the therapy tested (for previous disease).\n9. Patients with evolving tumors next to cavitary or major blood vessels at high risk of massive bleeding and\u002For perforation.\n10. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial.\n11. Major injuries and\u002For surgery within the past 4 weeks prior to start of study treatment with incomplete wound healing and\u002For planned major surgery during the on-treatment study period.\n12. History of clinically significant hemorrhagic or thromboembolic event in the past 3 months.\n13. History of significant cardiovascular diseases (i.e. supraventricular tachycardia, uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure \\> NYHA II, serious cardiac arrhythmia, pericardial effusion).\n14. Ongoing uncontrolled endocrinopathy. Ancient endocrinopathy currently stable with substitutive therapy should not be excluded from the trial.\n15. Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix. A history of more than 3 years of local prostate cancer treated by surgery and without PSA elevation since surgery, or local breast carcinoma treated by surgery without relapse or resected non-muscle invasive bladder cancers are eligible.\n16. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy. A wash out of more than 3 weeks is required after last systemic antibiotics to allow reconstitution of the microbiome. Patients infected by HIV but having efficient anti-retroviral therapy and CD4+ T-cell counts \\>500\u002Fmm³ are eligible. Patients with a history of HBV or HCV that are cured and have eligible liver function criteria are also eligible.\n17. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug in case an oral drug is tested in the sub-protocol for which the patient is screened.\n18. Pregnancy or breastfeeding.\n19. Intake of Ganoderma Lucidum mushroom (also called \"Reishi\") and\u002For herbal remedies and\u002For traditional medicines within the past weeks prior to start of trial treatment or concomitantly with the trial because of their potential to increase treatment related adverse events.\n20. Any psychological, familial, sociological, geographical factors, lifestyle, behavior, clinical or biological parameters or elements in the past medical history of the patients that, according to the investigator, could preclude the ability of the trial to directly reach its objectives, or indirectly via treatment observance or study follow up. Patients with active alcoholism and\u002For drug abuse are excluded.\n21. Person deprived of its liberty or under protective custody or guardianship.",{"count":598,"type":22},200,[25],"Most cancer treatments are developed without knowing whether the drug's targets are actually present in a patient's tumor or whether the patient is likely to benefit from the treatment. In addition, the immune environment surrounding the tumor changes significantly during the course of the disease, and the body's immune response to cancer tends to become less effective in later stages.\n\nCurrently, standard blood tests provide only basic information about a patient's immune, inflammatory, and metabolic systems. These tests do not offer a comprehensive picture of how each person's immune system is functioning. Similarly, traditional tests on tumor samples-which require frozen or preserved tissue and take a long time to process-are not fast enough to guide treatment decisions during clinical trials.\n\nNEOREM is a \"Master Protocol\" which includes multiple therapeutic sub-protocols testing new immunotherapy strategies. (Immunotherapy is a type of cancer treatment that helps the immune system fight cancer.) Neoadjuvant immunotherapies are treatments given before surgery. Their goals are to shrink the tumor to make it easier to remove, strengthen the immune system's ability to fight cancer, increase the chances of long-term recovery, and reduce the risk of the cancer returning.\n\nThis master protocol focuses on cancers that are still localized (have not spread) and aims to personalize treatments based on each patient's individual immuno-biological profile. As a part of this master protocol, a rapid analysis called PORTRAIT-which stands for \"Profile in Onco-Immunology for a Rapid Treatment Research Adapted to Immunity and Tumor\"-will be performed using fresh blood and tumor samples from each patient. This profiling uses highly sensitive and specific techniques to accurately detect biological markers that can predict how well someone will respond to immunotherapy before surgery.\n\nNEOREM's overall goal is to test new treatment strategies and new methods of selecting patients (using the PORTRAIT immune profiling) to improve the effectiveness of current standard treatments for certain types of cancer while also reducing their side effects.",[602],"Localized Cancer",[604,605,606],"Neo-adjuvant immunotherapy","Localized cancers","Tumor biology",{"date":555,"type":37},{"date":609,"type":37},"2026-01-21",{"date":611,"type":22},"2034-11",{"name":43,"class":44},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":637},"100585577","phase-2-durvalumab-and-tremelimumab-with-or-without-hepatic-arterial-infusion-of-chemotherapy-in-hepatocellular-carcinoma-100585577","NCT06904170","Durvalumab and Tremelimumab With or Without Hepatic Arterial Infusion of Chemotherapy in Hepatocellular Carcinoma","An Integrated Phase II\u002FIII Randomized Study Comparing Durvalumab and Tremelimumab +\u002F- Hepatic ArteriaL Infusion Chemotherapy With GEMOX in Hepatocellular Carcinoma With High Tumor burdEn","ALICE","Inclusion Criteria:\n\n* Age ≥18 years old,\n* Patient presenting with hepatocellular carcinoma (HCC), diagnosed either by histological or radiological criteria as described by EASL criteria, if no biopsy could be performed safely.\n* High-tumor burden, defined as at least one of the three criteria: (i) Vp4 PVTT, (ii) Vp3 PVTT with bilobar tumoral involvement and\u002For (iii) liver involvement \\>50% (as assessed by the investigator). Extra-hepatic spread is allowed.\n* Child-Pugh A liver function\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0 to 1\n* Must have a life expectancy of at least 12 weeks\n* Body weight \\>30 kg\n* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization\n* Adequate organ and marrow function as indicated by the following laboratory values\n\n  1. Haemoglobin ≥ 7.5 g\u002FdL. Participants with 7.5 g\u002FdL \\\u003C haemoglobin \\\u003C 9.0 g\u002FdL having active or chronic bleeding to be excluded,\n  2. Platelet count ≥75 × 109\u002FL,\n  3. Absolute neutrophil count (ANC ≥1.0 × 109 \u002FL)\n  4. creatinine clearance \\> 40 mL\u002Fmin (according to Cockcroft or MDRD formula)\n  5. AST (SGOT)\u002FALT (SGPT) ≤5x ULN\n  6. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n  7. International normalised ratio (INR) \\\u003C 2.3\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥90 days after the last dose of study drug, and have a negative urine or serum pregnancy test ≤7 days of first dose of study drug. In case of a urine pregnancy test, it must be a highly sensitive urine pregnancy test.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥90 days after the last dose of study drug. A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Males with known \"low sperm counts\" (consistent with \"sub-fertility\") are not to be considered sterile for purposes of this study.\n* Men and women patients must consent to not donate or bank sperm or ova during treatment and for 180 days after treatment stop\n* Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Patient affiliated to a social security regimen\n\nExclusion Criteria:\n\n* Previous systemic treatment (either immunotherapy, anti-angiogenics, chemotherapy, or any combination thereof)\n* Previous treatment with hepatic arterial infusion of chemotherapy\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* History of hepatic encephalopathy within the past 6 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy).\n* Active or prior documented gastrointestinal bleeding (GI; eg, esophageal varices or ulcer bleeding) within the past 6 months. Note: For participants with a history of GI bleeding greater than 6 months or assessed as high risk for esophageal varices by the investigator, including main trunk portal vein thrombosis, a recent endoscopy within 3 months of enrolment and adequate endoscopic therapy according to institutional standards is required.\n* Any unresolved toxicity NCI CTCAE grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n  1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n  2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.\n* Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  1. Patients with vitiligo or alopecia\n  2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  3. Any chronic skin condition that does not require systemic therapy\n  4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  5. Patients with celiac disease controlled by diet alone\n* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases\n* History of leptomeningeal carcinomatosis\n* Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Known to have been tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug\n* History of allogenic organ transplantation, or patient with intent for transplantation\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug. Note: Local surgery of isolated lesions for palliative intent is acceptable\n* Prior malignancy active within the previous 5 years of inclusion except for locally curable cancers considered cured or successfully resected, such as basal or squamous cell skin cancers, superficial bladder cancer, or gastric cancers, or carcinoma in situ of the prostate, cervix, or breast carcinomas. Any oncological concomitant treatment is not allowed during the treatment period.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab and tremelimumab combination therapy.\n* Participation in another therapeutic trial within the 30 days prior to study inclusion\n* Prior randomisation or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* Patients deprived of their liberty or under protective custody or guardianship\n* Patients unable to adhere to the protocol for geographical, social, or psychological reasons or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent",{"count":622,"type":22},196,[25,59],"Liver cancer is a highly lethal malignancy and has become increasingly important in western countries. The management of liver cancer is complex. In advanced disease, two combinations of immunotherapies are recommanded as first line (atezolizumab-bevacizumab or durvalumab-tremelimumab). Results in patients with high tumor burden (Portal vein thrombosis Vp3 or Vp4, or tumoral liver involvement \\>50%) are less impressive. Innovative combinations are necessary to improve the outcome of patients.\n\nRecently, control trials conducted in Asia highlighted the benefit of hepatic arterial infusion chemotherapy, especially in patients with high tumor burden. Studies including a limited number of patients shown that the combination seems feasible.\n\nALICE is a randomized multicentric Phase II\u002FPhase III trial conducted in French medical centers, evaluating the efficacy and safety of durvalumab+tremelimumab with or without Hepatic Arterial Infusion Chemotherapy of the GEMOX regimen (gemcitabine + oxaliplatin), in patients with high tumor burden.\n\nOxaliplatin induce immunogenic cell death, and gemcitabin deplete regulatory immune cells. The GEMOX regimen thus has the potential for a synergic effect with immunotherapy in HCC.\n\nThe trial will provide an innovative treatment to patients with no alternative for locoregional treatment, and with limited results with actual systemic treatments. It will also be the first trial of Hepatic Arterial infusion for such patients in the western population.",[626],"Hepatocellular Carcinoma",[628],"High tumor burden, HAIC, GEMOX, HCC,","2026-01-30",{"date":631,"type":37},"2026-02-03",{"date":633,"type":37},"2025-11-14",{"date":635,"type":22},"2030-09",{"name":43,"class":44},11,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":54,"minAge":432,"maxAge":646,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":653,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":660,"leadSponsor":662,"locationsCount":663},"100620685","study-aiming-to-test-whether-non-invasive-liquid-biopsies-can-safely-reduce-invasive-surveillance-methods-in-lynch-syndrome-100620685","NCT07360834","Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome","Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies","PREDI-LYNCH","Inclusion Criteria:\n\n1. Participant must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Age 35-80\n3. Genetically confirmed class 4-5 (likely pathogenic (LP) or pathogenic (P) variant, respectively) in MLH1, MSH2, MSH6, or EPCAM gene.\n4. The participant should be insurance covered for the financial costs of the standard surveillance and healthcare related to LS, such as affiliated to Social Security System\n\nExclusion Criteria:\n\n1. Previously performed proctocolectomy or equivalent (entire colon and rectum removed)\n2. Active treatment for cancer within 2 years prior to inclusion.\n3. Checkpoint inhibitor therapy within 12 months\n4. Pregnancy\n5. Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n6. Persons deprived of their liberty or under protective custody or guardianship.","80 Years",{"count":648,"type":22},2000,[117],"Lynch syndrome is an inherited genetic predisposition that increases the risk of developing several types of cancer, particularly colon and rectal cancers (colorectal cancer), as well as cancer of the uterine lining (endometrial cancer). It affects around 1 in 400 people in Europe.\n\nToday, surveillance mainly relies on examinations such as colonoscopy (an examination of the colon using a camera) or gynaecological evaluations, sometimes accompanied by biopsies (the removal of a small tissue sample for microscopic analysis). Although effective, these procedures are invasive and demanding; they can affect quality of life and discourage some individuals from adhering to their recommended surveillance programme.\n\nThe European project PREDI-LYNCH is exploring an additional pathway that is simpler and better tolerated. This project relies on \"liquid biopsies\", meaning tests performed on easily collected samples such as blood, urine, stool, and vaginal swabs for women with a uterus. The PREDI-LYNCH study aims to determine whether these non-invasive tests could enable personalised surveillance and potentially increase the interval between more burdensome procedures, while maintaining a high level of medical safety.",[652],"Lynch Syndrome",[654,655],"Lynch Syndrome, hereditary cancer, MMR deficiency, Liquid biopsies, cancer early detection.","Lynch Syndrome, MMR deficiency, Liquid biopsies","2026-01-22",{"date":658,"type":37},"2026-01-23",{"date":450,"type":22},{"date":661,"type":22},"2030-12-01",{"name":43,"class":44},9,{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":646,"enrollmentInfo":672,"targetDuration":4,"studyType":23,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":685},"100619126","phase-3-personalizing-chemotherapy-selection-after-surgery-for-patients-with-stage-iii-colorectal-cancer-using-a-blood-test-100619126","NCT07340567","Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test","Tailoring the Decision for Adjuvant Chemotherapy Using Circulating Tumour DNA, in Patients With Stage III Colorectal Cancer","CIRCULATEIII","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, an impartial witness of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n2. Age ≥18 years and \\\u003C80 years (for patients aged \\>70 years: G8 geriatric questionnaire score\\>14)\n3. Histologically confirmed stage III pMMR\u002FMSS colon and high rectum adenocarcinoma (T, N1 or N2, M0) excluding medium and low rectal cancers (≥12 cm from the anal verge by endoscopy and\u002For above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent.\n4. No metastatic disease on CT-Scan and\u002For liver MRI done within 2 months before inclusion\n5. Inclusion planned between 10 days to 6 weeks after surgery\n6. ECOG performance status 0-1 (fit to receive FOLFIRINOX therapy)\n7. No prior chemotherapy for CRC\n8. No prior abdominal or pelvic irradiation for CRC\n9. Adequate hematological function: neutrophils ≥1,500 \u002Fmm3, platelet count ≥100,000\u002Fmm3, hemoglobin ≥9 g\u002FdL (5,6 mmol\u002FL)\n10. Total bilirubin ≤1.5 x ULN (upper limit of normal)\n11. ASAT and ALAT ≤2.5 x ULN\n12. Alkaline phosphatase ≤2.5 x ULN\n13. Serum creatinine ≤120 μmol\u002FL or creatinine clearance ≥50 mL\u002Fmin according to Modification of Diet in Renal Disease (MDRD) formulae\n14. Tumor tissue available at baseline\n15. Women of childbearing potential must have negative serum pregnancy test done within 7 days before the start of study treatment\n16. Men and women of childbearing potential must agree to use adequate contraception methods for the duration of study treatment and for 6 months after treatment discontinuation\n17. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures\n18. Patient must be affiliated to a social security system (or equivalent) or according to local regulatory requirements\n\nExclusion Criteria:\n\n1. Peripheral neuropathy grade ≥1\n2. Patients who have received neo-adjuvant treatment.\n3. Comorbidity influencing the 3-year patients' survival including clinically relevant cardiovascular disease, such as Ischemic myocardial infarction in the last year and\u002For unstable ischemic cardiopathy\n4. Contra-indication to chemotherapy (inadequate bone marrow, hepatic, renal functions, hypersensitivity to one of the treatments or any of the excipients)\n5. Patient must not have received bone marrow transplant\n6. Patient must not have received blood transfusion within 3 months before inclusion\n7. Participation in another therapeutic trial\n8. Partial or complete dihydropyrimidine deshydrogenase (DPD) deficiency.\n9. MSI\u002FdMMR tumors\n10. Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years.\n11. Pregnant or breastfeeding women.\n12. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial social or psychological reasons\n13. Persons deprived of their liberty or under protective custody or guardianship.",{"count":673,"type":22},2450,[59],"CIRCULATE-III is an international, multicenter, open-label, randomized phase III trial designed to use ctDNA as a selection criterion for intensification or de-escalation of adjuvant chemotherapy. Eligible patients are randomly assigned to the following treatment groups:\n\n* Patients who test negative for ctDNA receive either capecitabine for 6 months (experimental group) or oxaliplatin + capecitabine for 3 months (standard group).\n* Patients who test positive for ctDNA receive either FOLFIRINOX for 6 months (experimental group) or FOLFOX for 6 months (standard group).\n\nPatient participation in the trial will not exceed 66 months after randomization, including a maximum treatment duration of 6 months and a follow-up period of 60 months.",[63],"2026-01-13",{"date":679,"type":37},"2026-01-14",{"date":681,"type":22},"2026-05-01",{"date":683,"type":22},"2035-11-01",{"name":43,"class":44},5,""]