[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,48,61,87,114,144,179,212,243,269,296,327,352,377,401,432,455,477,501,530,555,584,605],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053608","phase-2-multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100053608",false,"NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.","MALE","18 Years","120 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[27,28,29,30,31,32],"Adenocarcinoma","Prostate Cancer","Neoplasms","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[34],"Immune Infiltration","NOT_YET_RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-16",{"date":43,"type":21},"2028-06-15",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":25,"conditions":52,"keywords":53,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":47},"100641793",{"count":20,"type":21},[24],[27,28,29,30,31,32],[34],"2026-07-01",{"date":56,"type":39},"2026-07-02",{"date":58,"type":21},"2026-07-07",{"date":43,"type":21},{"name":45,"class":46},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100622598","phase-3-clinical-study-on-the-efficacy-and-safety-of-lm-302-injection-combined-with-tislelizumab-and-tislelizumab-combined-chemotherapy-for-the-treatment-of-gastric-or-gastroesophageal-junction-adenocarcinoma-100622598","NCT07385703","Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.","A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment:\n\n  * Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included.\n  * The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).\n* Archived specimens or fresh tumor tissue specimens from ≤3 years ago must be provided for CLDN18.2 and PD-L1 testing (PD-L1 results are not a condition for enrollment). When multiple samples are present, the most recent accessible and qualified sample must be provided. After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \\& 3+. For patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on platinum-containing combination chemotherapy regimens, newly obtained tissue from recurrent or metastatic lesions must be provided for CLDN18.2 and PD-L1 testing.\n* A negative report on the expression detection of human epidermal growth factor receptor-2 (HER2) in tumor tissue must be provided. The definition of HER2 negative expression is ImmunoHistoChemistry (IHC) score 0\u002F1+, IHC score 2+, and fluorescence in situ hybridization (FISH) negative.\n* According to the RECIST 1.1 evaluation criteria, there must be at least one measurable lesion.\n* Expected survival duration ≥ 3 months.\n* According to the Eastern Cooperative Oncology Group (ECOG) standards, the physical performance status score is 0 or 1.\n* Good organ function: a. Bone marrow reserve: Platelets (PLT) ≥ 100×10\\^9\u002FL, absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion or supportive treatment such as colony-stimulating factors within 14 days prior to hematology parameter examination during the screening period); b. Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×upper limit of normal (ULN); c. Liver function: Total bilirubin ≤ 1.5×ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5×ULN (if there is liver metastasis, then ALT and AST ≤ 5×ULN) and Albumin (ALB) ≥ 30 g\u002FL; d. Renal function: Creatinine clearance rate ≥ 50 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); e. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QT interval (QTcF) ≤ 470 ms for females and ≤ 450 ms for males.\n* Women of childbearing age must have a negative blood pregnancy test within 7 days before administration; any fertile male and female subjects must agree to use highly effective contraception throughout the study medication period and for 7 months after the last dose of the study. Males must agree to refrain from donating sperm during the study period and for 7 months after the last dose of the study. Females must agree to refrain from breastfeeding during the study period.\n\nExclusion Criteria:\n\n* Other pathological types confirmed by histopathology, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.\n* There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major bleeding.\n* Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled. Stable brain metastases are defined as patients whose brain metastases have undergone treatment and the condition of the metastases has stabilized (brain imaging examination at least 28 days before randomization shows stable lesions, no neurological symptoms, and no immediate need for local or systemic treatment within 14 days before randomization), with no evidence of new or previously existing brain metastases enlarging.\n* Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or planning to undergo local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy) within 14 days prior to screening, or significant increase within 2 weeks after local treatment, meeting any of the above criteria or deemed unsuitable for enrollment by the investigator.\n* Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord compression, there is no evidence indicating that the disease was clinically stable for ≥4 weeks before the first study drug administration; except for patients with asymptomatic spinal cord compression indicated by imaging, who are assessed as stable by a specialist and do not require treatment for spinal cord compression at this time.\n* Accompanied by severe peritoneal metastasis, the main manifestations are: clinically significant intestinal obstruction; barium enema indicating small intestinal stenosis.\n* History of gastrointestinal perforation or gastrointestinal fistula within the previous 6 months. If the perforation or fistula has been treated through resection or repair surgery, and the condition is assessed by the investigator as having been cured or controlled, participation in the study is permissible.\n* Poorly controlled tumor-related pain:\n\n  * For patients requiring analgesic treatment, a stable dosage of treatment must be established before participating in the study.\n  * Symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastasis causing nerve damage) should be treated before enrollment.\n  * Before enrollment, if appropriate, consideration should be given to local treatment for asymptomatic metastatic lesions that may lead to functional deficits or intractable pain due to further growth (e.g., epidural metastasis not currently associated with spinal cord compression).\n* Patients with a body weight of less than 35kg or a body weight loss of more than 10% within 2 months prior to signing the informed consent form.\n\nExclusion criteria for comorbidities or concomitant conditions:\n\n* History of malignancy other than Gastric Cancer (GC)\u002FGastroEsophageal Junction adenocarcinoma (GEJ) adenocarcinoma within 2 years prior to randomization, with the following exceptions: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, squamous cell carcinoma of the skin, etc., which have been completely cured and treated.\n* History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following conditions are excluded: • Subjects with autoimmune-related hypothyroidism who are receiving stable-dose thyroid hormone replacement therapy.\n\n  * Subjects with type 1 diabetes who are well-controlled under a stable insulin treatment regimen.\n  * Only subjects with skin autoimmune diseases that do not require systemic treatment (such as vitiligo, alopecia, psoriasis, or eczema).\n  * Subjects who have recovered from childhood asthma and do not require any intervention in adulthood.\n  * Subjects whose relevant diseases, as assessed by the researchers, are unlikely to recur without external triggers.\n* Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation.\n* Patients with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  * Severe cardiac rhythm or conduction abnormalities, such as arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, left bundle branch block, prolonged QRS complex, etc.;\n  * Patients with thromboembolic events requiring therapeutic anticoagulation, or those with venous filters;\n  * Patients with heart failure of New York Heart Association (NYHA) class III or IV;\n  * Patients who have experienced acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other cardiovascular and cerebrovascular events of grade 3 or above within the previous 6 months prior to randomization.\n  * Have a history of myocarditis or cardiomyopathy.\n* For individuals infected with human immunodeficiency virus (HIV) and those with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the following conditions are allowed for enrollment: • Patients who are HBsAg positive, with or without HBcAb positivity, and have HBV DNA \\\u003C 500 IU\u002FmL or below the lower limit of the reference value set by the research center, and who, based on clinical treatment, manifestations, and other factors, are judged by the investigator to have no active infection; • Patients who are HCV antibody positive but HCV RNA negative.\n* Subjects with known active syphilis infection.\n* Individuals who are unable to control themselves or have severe illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks before the first dose, and interstitial pneumonia\u002Flung disease requiring intervention during screening.\n* Subjects with known active tuberculosis. For patients suspected of having active tuberculosis, a comprehensive evaluation should be conducted based on chest imaging, sputum smear\u002Fculture, or molecular testing results, as well as clinical symptoms and signs, to make a definitive diagnosis.\n* Currently present peripheral sensory or motor neuropathy of ≥ grade 2.\n* Subjects who received systemic corticosteroids (\\>10mg\u002Fd prednisone equivalent) or other systemic immunosuppressants (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs \\[anti-Tumor Necrosis Factor (TNF)\\] within 2 weeks prior to the first study drug administration.\n\n  * Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed;\n  * Patients receiving acute low-dose systemic immunosuppressive drugs (e.g., single-dose dexamethasone for nausea);\n  * Patients requiring baseline and subsequent MRI\u002FCT tumor assessments who have previously experienced allergic reactions to intravenous contrast agents may receive prophylactic steroids;\n  * Inhaled corticosteroids are allowed for the treatment of chronic obstructive pulmonary disease, hydrocortisone for the treatment of orthostatic hypotension, and low-dose corticosteroid hormone maintenance therapy for adrenal insufficiency.\n* There are factors that affect the application and absorption of oral medications, such as dysphagia, clinically uncontrollable persistent and recurrent vomiting (such as caused by gastric outlet obstruction), intestinal obstruction, and chronic diarrhea. 21. Within 28 days before randomization, there was uncontrollable\u002Fsevere gastrointestinal bleeding, active peptic ulcer, or active gastrointestinal inflammation\u002Finfectious diseases (such as active diverticulitis, abdominal abscess). Subjects who have not undergone radical surgical resection of the primary lesion must undergo fecal occult blood testing before enrollment. If the result is positive, further evaluation, including but not limited to gastroscopy, is required before medication administration to confirm the presence of active bleeding from the lesion and assess the risk of bleeding.\n* The adverse reactions from previous anti-tumor treatment within the 14 days prior to randomization have not yet recovered to a level of ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grading system (excluding toxicities that the investigator deems to pose no safety risk, are asymptomatic, or are controllable with stable medication, such as hair loss, long-term toxicity caused by radiotherapy, and other toxicities that are ≤ grade 2).\n* Have a history of allergy to LM-302, Ticagrelor, any control drug, or its excipients.\n* Individuals with known mental illnesses or disorders that may affect trial compliance.\n\nExclusion criteria related to drug treatment:\n\n* Within 28 days prior to randomization, the subject is currently participating or has previously participated in any investigational drug study, or has used an investigational device within 28 days. Subjects who have entered the follow-up period of an investigational drug study and have not used the investigational drug for ≥28 days since the last use may meet the inclusion criteria for this study.\n* Previously received targeted therapy targeting CLDN18.2, such as antibody-drug conjugate (ADC) therapy, antibody therapy, and chimeric antigen receptor T-cell (CAR-T) therapy; previously received ADC therapy using small molecule toxin Monomethyl auristatin E (MMAE).\n* Subjects who have received palliative local treatment (such as radiotherapy or surgery) for non-target lesions within 2 weeks prior to the first dose, or who have previously received radiotherapy for locally advanced unresectable or metastatic gastric cancer or GEJ adenocarcinoma and have not recovered from toxicity within 2 weeks prior to randomization.\n* Within the first 2 weeks before randomization, patients received systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications, or with Chinese herbal medicine, or with drugs with immune regulatory effects (including thymosin, interferon, interleukin, etc.).\n* Having undergone or planning to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within the 28 days prior to randomization or during the study period.\n* Use of strong inhibitors\u002Fstrong inducers of CYP3A4 within 14 days before randomization;\n* Vaccination with any live vaccine or attenuated live vaccine within 28 days before randomization.\n* Other situations where the researcher deems it inappropriate for participation in this study.","ALL",{"count":70,"type":21},752,[72],"PHASE3","This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.",[27],"RECRUITING","2026-06-23",{"date":78,"type":39},"2026-06-25",{"date":80,"type":39},"2026-04-15",{"date":82,"type":21},"2030-05",{"name":84,"class":85},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","INDUSTRY",106,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100612879","phase-2-relacorilant-with-nab-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-adenocarcinoma-100612879","NCT07259317","Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)","Inclusion Criteria:\n\n* Signed and dated informed consent form prior to screening procedures\n* Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)\n* Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study\n* Life expectancy of ≥3 months\n* Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to provide informed consent and comply with protocol requirements\n* Able to swallow and retain oral medication and does not have uncontrolled emesis\n* Has adequate gastrointestinal absorption\n* Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.\n* If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred \\>12 months after completing the last dose, and no persistent treatment-related toxicities can be present.\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n* Agree to use protocol defined precautions to avoid pregnancy\n\nExclusion Criteria:\n\n* Any major surgery within 4 weeks prior to enrollment\n* Prior treatment as follows:\n\n  1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease\n  2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug\n* Received gemcitabine or nab-paclitaxel to treat their PDAC\n* Known germline or somatic breast cancer gene (BRCA) mutation\n* Peripheral neuropathy from any cause \\>Grade 1\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* History of severe hypersensitivity or severe reaction to any of study drugs or their excipients\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Active infection with HIV, hepatitis C or hepatitis B virus\n* Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Taking protocol-prohibited medications\n* Concurrent treatment with other investigational treatment studies for cancer\n* Has received a live vaccine within 30 days prior to the study start date",{"count":95,"type":21},80,[24],"This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).",[27,99],"Carcinoma, Pancreatic Ductal",[101,27,102,103],"Pancreatic","PDAC","Pancreas","2026-06-15",{"date":106,"type":39},"2026-06-17",{"date":108,"type":39},"2026-01-27",{"date":110,"type":21},"2027-09",{"name":112,"class":85},"Corcept Therapeutics",14,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":47},"100219375","phase-2-t-cell-receptor-immunotherapy-for-patients-with-metastatic-non-small-cell-lung-cancer-100219375","NCT02133196","T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer","A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen","* INCLUSION CRITERIA:\n\n  1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)\n  2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n  3. All patients must have had at least one appropriate first line systemic therapy and progressed.\n  4. Clinical performance status of ECOG 0 or 1.\n  5. Age \\>= 18 years of age and \\\u003C= 72 years of age.\n  6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.\n  7. Willing to sign a durable power of attorney\n  8. Able to understand and sign the Informed Consent Document\n\nI. Hematology:\n\n* Absolute neutrophil count \\> 1000\u002Fmm\\^3 without support of filgrastim\n* Normal WBC (\\>= 2500\u002Fmm\\^3).\n* Hemoglobin \\> 8.0 g\u002Fdl. Subjects may be transfused to reach this cut-off.\n* Platelet count \\>= 80,000\u002Fmm\\^3\n\n  j. Serology:\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  k. Chemistry:\n* Serum ALT\u002FAST \\\u003C= 2.5 times the upper limit of normal.\n* Serum creatinine \\\u003C= 1.6 mg\u002Fdl.\n* Total bilirubin \\\u003C= 2 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C= 3 mg\u002Fdl.\n\n  l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\n  m. Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.\n\nn. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.\n\no. Subjects must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.\n2. Ongoing need for pharmacological immunosuppression, including steroids\n3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses\n4. Major bronchial occlusion or bleeding not amenable to palliation.\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\n\n   Disease and AIDS).\n6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \\\u003C= 45%.\n9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \\\u003C= 50%\n10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\n\n    * Greater than 2 invasive thoracic procedures\n    * Poor exercise tolerance\n    * Greater than 66 years of age\n    * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.\n11. Patients who are receiving any other investigational agents.","72 Years",{"count":123,"type":21},85,[24],"Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.\n\nDesign:\n\n* Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed\n* Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n* Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}\n* Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.",[127,128,129,130,27],"Advanced Non-Small Cell Lung Cancer","Squamous Cell Carcinoma","Advanced NSCLC","Adenosquamous Carcinoma",[132,133,134,135],"Metastatic","Non-Small Cell Lung Cancer","NSCLC","Lung Cancer","2026-06-05",{"date":138,"type":39},"2026-06-08",{"date":140,"type":39},"2014-10-23",{"date":142,"type":21},"2027-10-23",{"name":45,"class":46},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":47},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":152,"type":21},25,[154],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[27,157,128,158,159,160,161,162,163,164,165,166,167,168,169],"Basal Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":136,"type":39},{"date":173,"type":39},"2026-05-01",{"date":175,"type":21},"2028-05-01",{"name":177,"class":178},"University of California, Irvine","OTHER",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":186,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100483906","phase-3-para-aortic-lymphadenectomy-in-locally-advanced-cervical-cancer-100483906","NCT05581121","PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer","PAROLA","Inclusion Criteria:\n\n1. Age ≥ 18 years at time of study entry\n2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor\n3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET\u002FCT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes in the common iliac and para-aortic regions. The highest positive lymph node must be located inferior to the common iliac bifurcation in both sides (anatomical level 1).\n4. Patients with TNM T stage I-IIIB.\n5. FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or from final histology - patients are not eligible after radical hysterectomy, and FDG-negative common iliac of para-aortic lymph node on PET\u002FCT (performed before or after SLN procedure)\n6. Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board\n7. ECOG performance status \\\u003C 2 i.e. 0 or 1\n8. Life expectancy more than 12 months\n9. Pretherapeutic imaging FDG-PET\u002FCT images should be available for central review\n10. Prior validation of the surgeon's participation in the study by the Quality Assurance Comity\n11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study entry.\n12. 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\n13. Not applicable since protocol revision V4. Patient participating to other clinical trials including immunotherapy strategies or adjuvant chemotherapy is also eligible for the study. Adjuvant treatment must be decided prior to randomization\n14. Signed informed consent\n15. Patient affiliated to a Social Health Insurance in France (French patients only).\n\nExclusion Criteria:\n\n1. Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n2. Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n3. Metastatic disease confirmed by FDG-PET\u002FCT\n4. Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma\n5. Contraindication for cisplatin-based chemotherapy\n6. Women who received any prior treatment for cervical cancer\n7. Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging\n8. Previous pelvic radiotherapy\n9. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease after 5 years, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ (any location) without evidence of disease.\n10. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n11. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","FEMALE",{"count":188,"type":21},510,[72],"This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET\u002FCT only followed by chemoradiation.\n\nThe planned sample size is 510; including 200 patients in France.\n\nIn this trial, patients will be assigned in one of the two following treatments arms:\n\n* Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO\u002FESTRO recommendations.\n* Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy.\n\nConsidering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician.\n\nEach patient will be followed up for 5 years.\n\nA cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET\u002FCT only followed by chemo-radiation.\n\nThis study also has ancillary objectives:\n\n* Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche.\n* Radiomics: To study the contribution of radiomics and FDG-PET\u002FCT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome.\n* Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.",[192,27,130],"Cervical Carcinoma",[194,195,196,197,198,199,200,201],"Locally advanced cervical cancer","HPV 16+","Stage IIIC1","Radiation therapy","Cisplatin","Para-aortic lymphadenectomy","INTERLACE","KEYNOTE-A18","2026-05-21",{"date":204,"type":39},"2026-05-26",{"date":206,"type":39},"2023-12-20",{"date":208,"type":21},"2033-12-20",{"name":210,"class":178},"Institut Claudius Regaud",35,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":47},"100577113","efficacy-and-safety-of-multimodal-ablation-combined-with-pd-1-monoclonal-antibody-lenvatinib-and-tace-in-the-treatment-of-unresectable-primary-hepatocellular-carcinoma-a-single-arm-single-center-clinical-study-100577113","NCT06794073","Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender.\n2. Clinically or pathologically confirmed HCC.\n3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.\n4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \\>5 cm.\n5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..\n6. ECOG PS 0-1 and an expected survival \\>3 months.\n7. Child-Pugh score ≤7.\n\nExclusion Criteria:\n\n1. Child-Pugh class C liver dysfunction.\n2. Tumor thrombus in the main portal vein or hepatic vein.\n3. Extensive metastatic disease with an expected survival \\\u003C3 months.\n4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).\n5. History of esophageal\u002Fgastric variceal bleeding within the past month.\n6. History of other malignancies.\n7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \\\u003C1 month.\n8. Active infection; HBV co-infection (HBV DNA ≥2000 IU\u002FmL or ≥10⁴ copies\u002FmL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.\n9. History of organ transplantation or hepatic encephalopathy.\n10. Uncorrectable coagulation disorders.\n11. Refractory massive ascites, pleural effusion, or cachexia.\n12. Pregnancy, impaired consciousness, or inability to comply with treatment.\n13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \\>12).\n14. Any other condition deemed unsuitable by investigators that may affect study participation.","80 Years",{"count":220,"type":21},17,[222],"NA","This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.",[225,31,27,226,227],"Carcinoma, Hepatocellular","Digestive System Neoplasms","Liver Neoplasms",[229,230,231,232,233],"Multimodal","Tislelizumab","lenvatinib","TACE","unresectable primary liver cancer","2026-05-08",{"date":236,"type":39},"2026-05-11",{"date":238,"type":39},"2026-01-31",{"date":240,"type":21},"2027-08-31",{"name":242,"class":178},"Shanghai Zhongshan Hospital",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":47},"100444308","early-phase-1-using-a-pet-imaging-agent-18f-clofarabine-cfa-to-measure-deoxycytidine-kinase-activity-in-metastatic-cancer-100444308","NCT05065736","Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer","18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine","Inclusion Criteria:\n\n* Histologically or cytologically proven metastatic cancer (including carcinoma, adenocarcinoma, sarcoma, or neuroendocrine cancer).\n* Subjects must have metastatic disease, confirmed by imaging, typically a CT scan of the chest\u002Fabdomen\u002Fpelvis.\n* Subjects must have measurable disease per RECIST 1.1\n* Over 18 years of age\n* ECOG performance status 0-1\n* Adequate organ function as defined by the following criteria (labs may be no more than 4 weeks prior to the screening date):\n\n  * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \\[SGOT\\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C= 2.5 x laboratory upper limit of normal (ULN)\n  * Total serum bilirubin \\\u003C= 2.0 x ULN\n  * Absolute neutrophil count (ANC) \\>= 1500\u002FuL\n  * Platelets \\>= 75,000\u002FuL\n  * Hemoglobin \\>= 8.0 g\u002FdL\n  * Serum calcium \\\u003C= 12.0 mg\u002FdL\n  * Serum creatinine \\\u003C= 2.9 mg\u002FdL\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document\n* Patient is able to remain still for the duration of the imaging procedure (up to one hour).\n\nExclusion Criteria:\n\n* Within 6 months prior to enrollment on this study: myocardial infarction, severe\u002Funstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary\u002Fperipheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism.\n* Pregnancy or breastfeeding (pregnant or breastfeeding women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects.\n* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.",{"count":251,"type":21},4,[154],"The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET\u002FCT, can be used to image cancer pyrimidine metabolism in participants.\n\nPET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.",[255,30,27],"Metastatic Cancer",[257,258,259],"18F-Clofarabine","Diagnostic Imaging","Cancer","2026-03-17",{"date":262,"type":39},"2026-03-19",{"date":264,"type":39},"2023-03-06",{"date":266,"type":21},"2026-06",{"name":268,"class":178},"Roberto Vargas",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":18,"enrollmentInfo":276,"targetDuration":4,"studyType":278,"phases":4,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100525946","anatomical-clinical-base-of-adenocarcinoma-pancreatic-100525946","NCT06128343","Anatomical-Clinical Base of Adenocarcinoma Pancreatic","BACAP-2","Inclusion Criteria:\n\n* Patient with pancreatic mass syndrome explored by ultrasound endoscopy with cytopuncture or\n* Patient with pancreatic mass syndrome explored by an abdominal scanner with and without injection of product contrast and\u002For puncture of the mass or secondary lesions by radiological route or\n* Patient with pancreatic adenocarcinoma proven histologically and\u002For cytologically\n\nExclusion Criteria:\n\n* Patient with a pancreatic tumor whose analysis histological is not an adenocarcinoma\n* Pregnant or breastfeeding patient",{"count":277,"type":21},1500,"OBSERVATIONAL","BACAP-2 is a prospective biobank dedicated to the pancreatic adenocarcinoma including clinical data and biological samples from tumor. The aim is to enrich the previous propective collection BACAP in order to support future research projects.",[27,30,29],[27,282,283,284,285,286],"fine-needle aspiration","endoscopic ultrasonography","epidemiology","biobank","DNA tumors","2026-03-16",{"date":262,"type":39},{"date":290,"type":39},"2023-11-16",{"date":292,"type":21},"2035-02-28",{"name":294,"class":178},"University Hospital, Toulouse",8,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":304,"targetDuration":306,"studyType":278,"phases":4,"briefSummary":307,"conditions":308,"keywords":314,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100592655","prospective-data-collection-initiative-on-thoracic-malignancies-100592655","NCT06996249","Prospective Data Collection Initiative on Thoracic Malignancies","Prospective Data Collection Initiative on Thoracic Malignancies - a Prospective Observational Cohort Study","DuTOC","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Histo\u002Fcytopathological proof of a thoracic malignancy, or a strong suspicion (after imaging and multidisciplinary board);\n* Informed consent for longitudinal observational data collection;\n\nExclusion Criteria:\n\n* Mentally challenged patients that are unable to provide conscientious informed consent as determined by the investigator.\n* Inability to provide a written or electronic informed consent.",{"count":305,"type":21},12000,"50 Years","Survival after cancer diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of molecular factors, biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage. It is however still unclear which, how, and to what extent these factors will influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) thoracic malignancies such as lung cancer.\n\nAlthough the results from prospective clinical trials will remain the backbone of evidence-based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of patients with cancer do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications:\n\n1. It is highly desirable to validate the results from clinical trials in the general patient population. This is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters.\n2. There is an ever increasing number of therapeutic interventions available for which its efficacy depends on known and unknown tumor-specific, clinical, demographic and other patient characteristics. Large numbers of patients are required to test the relevance of these variables.\n3. As a result of rapid technical and drug developments, new minimally invasive treatment options such as stereotactic irradiation or ablation techniques or sublobar resections and new targeted and immunotherapeutic treatments have entered the clinic. These interventions have potentially less side effects compared to the conventional treatments. Still, these new interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) in a real world setting.\n4. Many hypotheses related to further optimization of personalized medicine can currently not be tested as they require a large prospective cohort of patients, and a less time-consuming and costly research infrastructure.\n\nA prospective observational cohort study has the potential to fill the gap between prospective randomized trials (efficacy) and patients treated in general practice (effectiveness) and it will enable accrual of clinical trials (innovation).",[135,309,310,27,128,311,312,313],"Thoracic Cancer","Lung Cancer, Nonsmall Cell","Large Cell Lung Cancer","Thymus Cancer","Mesothelioma",[315,316],"Dutch lung cancer cohort","lung cancer cohort","2026-03-02",{"date":319,"type":39},"2026-03-03",{"date":321,"type":39},"2025-08-15",{"date":323,"type":21},"2030-01-01",{"name":325,"class":178},"Dutch Society of Physicians for Pulmonology and Tuberculosis",10,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100519636","clinical-genetic-and-environmental-determinants-of-prostate-cancer-progression-100519636","NCT06046131","Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.","KP-CARAIBES","Inclusion Criteria:\n\nInclusion criteria:\n\nAdult patients with incident case of prostate cancer Patient consulting the University Hospital of Guadeloupe or the University Hospital of Rennes Patient who resides in the departments of Guadeloupe or Martinique or the community of Saint-Martin or in Britany Patient affiliated or beneficiary of the social security signed consent\n\nExclusion Criteria:\n\nPhysical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).",{"count":335,"type":21},3000,[222],"The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .",[339,27,340,341],"Prostatic Neoplasm","Neoplasm Recurrence","Neoplasm Metastasis","2025-11-14",{"date":344,"type":39},"2025-11-17",{"date":346,"type":39},"2023-02-28",{"date":348,"type":21},"2039-02-28",{"name":350,"class":178},"Centre Hospitalier Universitaire de la Guadeloupe",2,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":47},"100390268","phase-1-safety-of-combining-irinotecan-with-5-fu-leucovorinfolinic-acid-oxaliplatin-and-docetaxel-chemotherapies-100390268","NCT04361708","Safety of Combining Irinotecan With 5-FU, Leucovorin\u002FFolinic Acid, Oxaliplatin, and Docetaxel Chemotherapies","A Phase 1 Dose Finding Study of the gFOLFOXIRITAX Regimen Using UGT1A1 Genotype-directed Irinotecan With Fluorouracil, Leucovorin, Oxaliplatin and Taxotere in Patients With Untreated Advanced Upper Gastrointestinal Adenocarcinomas: The I-FLOAT Study","I-FLOAT","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with upper GI primary suspected), or other primary GI malignancy for which the treating physician feels that I-FLOAT is a reasonable therapeutic option.\n2. Patients with a history of obstructive jaundice due to the primary tumor must have resolved to \\\u003C1.5 X upper limit of normal and a metal biliary stent in place\n3. Age greater than or equal to 18 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status =1\n5. Life expectancy \\> 3 months\n6. Adequate organ function, as defined by each of the following:\n\n   Absolute neutrophil count (ANC) = 1500\u002FuL Hemoglobin \\> 9g\u002FdL (transfusion permitted with stability for \\> 1 week) Platelets \\> 100,000\u002FuL Total bilirubin = 1.5 mg\u002FdL AST and ALT = 2.5 X upper limit of normal; alkaline phosphatase = 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis.\n\n   AST and ALT = 5 X upper limit of normal if hepatic metastases are present. Creatinine = 1.5 mg\u002FdL\n7. Measurable or non-measurable disease will be allowed.\n8. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.\n9. Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential\n10. Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan.\n\nExclusion Criteria:\n\n1. Prior radiation therapy for any cancer.\n2. Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met\n3. Inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n4. Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v. 4.0\\*). Pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement.\n5. Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0.\n6. Documented brain metastases\n7. Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment.\n8. Active uncontrolled bleeding.\n9. Pregnancy or breastfeeding.\n10. Major surgery within 4 weeks.\n11. Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%, and meets all other eligibility criteria.",{"count":361,"type":21},54,[363],"PHASE1","The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin\u002Ffolinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin\u002Ffolinic acid is a vitamin to make 5-FU work well).",[366,367,27],"Pancreatic Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","2025-09-29",{"date":370,"type":39},"2025-10-01",{"date":372,"type":39},"2020-05-08",{"date":374,"type":21},"2027-05",{"name":376,"class":178},"University of Chicago",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":351},"100367821","phase-2-novel-sequenced-immunotherapy-with-anti-angiogenesis-and-chemotherapy-in-advanced-gastroesophageal-adenocarcinoma-100367821","NCT04069273","Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma","Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma","SEQUEL","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status (PS) of 0-1within 28 days prior to registration. NOTE: Within 0-3 days prior to the anticipated C1D1, ECOG PS must be 0-1.\n* Tumor tissue must be obtained from a biopsy performed either (a) prior to registration or (b) prior to C1D1, as described below.\n\n  * Prior to registration: if a biopsy was performed prior to registration and no interval systemic anti-cancer treatment was administered between the biopsy collection and C1D1, part of that tissue is required for correlative analysis, and must be identified during screening and shipped after registration. In this situation, tissue from a new biopsy is not required.\n  * Prior to C1D1: For all other subjects, a new biopsy prior to C1D1 is required (research biopsy per parallel biopsy protocol entitled: \"Exploration of tumor biology in patients with metastatic esophageal and gastric cancer\", \\[biorepository protocol for prospective tissue collection\\]) to obtain tissue.\n  * NOTE: If tissue cannot be obtained by either of the above approaches (e.g., clinically contraindicated), the subject is not eligible for trial participation.\n* Willingness to provide tissue and blood samples for correlative research purposes and presence of a malignant lesion that is amenable to repeat biopsy while on study protocol (e.g., primary tumor that can be accessed by EGD).\n\n  --NOTE: Enrollment in parallel biopsy protocol, if open for enrollment, is required. Parallel biopsy protocol entitled: \"Exploration of tumor biology in patients with metastatic esophageal and gastric cancer (biorepository protocol for prospective tissue collection)\".\n* PD-L1 results are required, if available. If PD-L1 testing has not been done, it should be ordered as standard of care prior to C1D1. PD-L1 testing must be performed by a CLIA certified lab using the Dako 22C3 antibody.\n* Histologically or cytologically proven adenocarcinoma of the stomach or GEJ.\n* Metastatic, recurrent, or locally advanced unresectable disease.\n* Candidate for pembrolizumab, ramucirumab, and paclitaxel (or nab-paclitaxel)\n* Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration. NOTE: Labs must also be obtained within 10 days prior to C1D1 treatment.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1,100\u002Fmm3\n  * Hemoglobin (Hgb) ≥ 8.5 g\u002FdL without transfusion or EPO dependency\n  * Platelets ≥ 100,000 \u002F mcL\n  * Creatinine OR Calculated creatinine clearance (institutional standard for calculation of CrCl may be used) ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional ULN\n  * Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN OR total bilirubin ≤ 2 x ULN if liver metastases are present (patients with Gilbert's syndrome are allowed)\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 x ULN for subjects with liver metastases\n  * Albumin \\> 3.0 g\u002FdL\n* Females of childbearing potential must have a negative pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use 2 forms of effective methods of contraception from the time of informed consent (females)\u002Fprior to C1D1 (males) until 120 days after treatment discontinuation.\n* Willingness to return to the enrolling institution for follow up\n\nExclusion Criteria for all cohorts:\n\n* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease (relevant for ramucirumab).\n* Any of the following cardiac criteria:\n\n  * Clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., clinically important forms of complete left bundle branch block, third degree heart block, second degree heart block, mean resting corrected QT interval (QTc using Fridericia's formula) \\> 470 msec, PR interval \\>250msec. NOTE: Investigators are encouraged to discuss potentially clinically important arrythmias with a cardiologist and consider implementing more frequent monitoring if appropriate (e.g., more frequent ECGs).\n  * Symptomatic heart failure, uncontrolled hypokalemia despite repletion, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives. NOTE: Factors that increase risk of QTc prolongation or risk of arrhythmia, such as concomitant medications, may require increased monitoring during Combination Therapy (See Section 7).\n  * The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy.\n  * The patient has uncontrolled or poorly-controlled hypertension (\\>160 mmHg systolic or \\> 100 mmHg diastolic for \\>4 weeks) despite standard medical management.\n* The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy (relevant for ramucirumab).\n* Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis (relevant for ramucirumab).\n* Hemoptysis (defined as bright red blood or ≥ 1\u002F2 teaspoon) within 2 months prior to first dose of protocol therapy or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer (relevant for ramucirumab) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has a prior history of GI perforation\u002Ffistula (within 6 months of first dose of protocol therapy) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with ramucirumab.\n* The patient has undergone major surgery within 28 days prior to first dose of protocol therapy prior to the first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial (relevant for ramucirumab).\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.\n* Has active autoimmune disease that has required systemic treatment in the past 6 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when combined with pembrolizumab. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. NOTE: Inhaled steroids or steroid injections for joint disease are allowed.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Prior therapy combining anti-angiogenesis agent with cytotoxic agent(s). NOTE: Prior single-agent anti-angiogenesis therapy (eg, ramucirumab monotherapy) is allowed.\n* Patients known to be HIV positive.\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Prior severe allergic reactions to a monoclonal antibody or hypersensitivity to pembrolizumab or any of its excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb), excluding anti-PD-1\u002F-L1 therapy, within 3 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 3 weeks earlier.\n* Other active malignancy which requires current treatment and which in the opinion of the site investigator is likely to interfere with evaluation of disease assessment. NOTE: Continuation of hormonal therapies is allowed.\n* Patients with known active central nervous system (CNS) metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Uncontrolled intercurrent illness which in the opinion of the investigator poses unacceptably high risk when combined with study treatment, including but not limited to the following:\n\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Severely impaired lung function\n  * Known history of active TB (Bacillus Tuberculosis)\n  * Uncontrolled diabetes as defined by fasting serum glucose \\>1.5 x ULN (NOTE: Optimal glycemic control should be achieved before starting trial therapy.)\n  * Significant underlying liver disease such as severe cirrhosis or hepatic impairment\n  * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has an active infection requiring systemic therapy prior to therapy initiation and that in the opinion of the investigator poses unacceptably high risk as standard clinical practice when starting study treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has known history of or any evidence of active, non-infectious pneumonitis that in the opinion of the investigator poses unacceptably high risk as standard of clinical practice when starting study treatment.\n* Currently uncontrolled hyper\u002Fhypothyroidism or hyper\u002Fhypocortism if in the opinion of the investigator they pose unacceptably high risk when combined with study treatment.\n* Received live vaccine or live attenuated vaccine within 30 days prior to registration. NOTE: Administration of killed vaccines is allowed.\n* Prior toxicity from immune checkpoint inhibitors (eg. pancreatitis, enteritis) that was symptomatic or required medical intervention ≤ 6 months prior to registration, which in the opinion of the investigator poses unacceptably high risk as standard clinical practice when starting study treatment.\n* Pre-existing motor or sensory neurotoxicity grade 3 or higher.\n* Prior solid organ or allogeneic transplant.\n\nEligibility specific to Cohort 1:\n\n* Inclusion: Measurable disease per RECIST v1.1\n* Exclusion: Disease progression according to RECIST v1.1 or irRECIST, or treatment intolerance, during prior therapy with an anti-PD-1, anti-PD-L1, or anti- PD-L2 agent. NOTE: Stable or responsive disease on anti-PD-1\u002FL1-L2 therapy (without concurrent cytotoxic therapy) is allowed.\n* Exclusion: Weight loss ≥ 5% during prior anti-PD-1, anti-PD-L1, or anti- PD-L2-containing therapy (from time of initiation of such therapy to most recent dose).\n\nEligibility specific to Cohort 2:\n\n* Inclusion: Measurable or evaluable disease per RECIST v1.1.\n* Inclusion: Received anti-PD-1 therapy with or without concurrent cytotoxic chemotherapy as preceding therapy.\n* Inclusion: PD-L1 combined positive score (CPS) ≥ 1 or tumor proportion score (TPS) ≥ 1 at any time before registration. NOTE: PD-L1 expression status in tissue samples collected at baseline before receiving any prior systemic anticancer therapy are of highest interest.",{"count":386,"type":21},58,[24],"Cohort 1 \\[CLOSED\\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions.\n\nCohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.",[390,391,27],"Gastric Cancer","GastroEsophageal Cancer","2025-07-29",{"date":394,"type":39},"2025-07-31",{"date":396,"type":39},"2020-12-01",{"date":398,"type":21},"2026-12-10",{"name":400,"class":178},"Harry H Yoon",{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":429,"locationsCount":431},"100483408","imperial-prostate-7---prostate-assessment-using-comparative-interventions---fast-mri-and-image-fusion-for-cancer-100483408","NCT05574647","Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer","Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer","IP7-PACIFIC","Randomisation 1\n\nInclusion Criteria:\n\n* Age 18 years or above (no upper limit)\n* Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).\n* Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and\u002For an elevated PSA (within 6 months of screening visit) PSA \\>\u002F=3.0ng\u002Fml for age 50-69 years PSA \\>\u002F=5.0ng\u002Fml for age \\>\u002F=70 years If family or ethnic risk for prostate cancer, PSA \\>\u002F=2.5ng\u002Fml for age 45-49 years\n\nExclusion Criteria:\n\n* PSA \\>50ng\u002Fml\n* Prior prostate MRI or prostate biopsy in the two years prior to screening visit\n* Prior diagnosis of prostate cancer\n* Contraindication to MRI or gadolinium contrast\n* Previous hip replacement to both hips\n* Contraindication to performing a biopsy guided by a transrectal ultrasound probe\n\nRandomisation 2\n\nInclusion Criteria:\n\n* Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)\n\nExclusion Criteria:\n\n* As above for randomisation 1\n* Patient refusal for biopsy",{"count":410,"type":21},3600,[222],"To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.\n\nTo determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.\n\nTo determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.",[28,27,414,415,29],"Prostatic Neoplasms","Prostatic Diseases",[28,417,418,419,420,421,422],"Prostate-Specific Antigen","bpMRI","mpMRI","Prostate biopsy","Multi-parametric MRI","Biparametric MRI","2025-07-21",{"date":425,"type":39},"2025-07-24",{"date":427,"type":39},"2022-11-02",{"date":238,"type":21},{"name":430,"class":178},"Imperial College London",15,{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100404187","phase-2-chemo4metpanc-combination-chemokine-inhibitor-immunotherapy-and-chemotherapy-in-pancreatic-adenocarcinoma-100404187","NCT04543071","Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma","A Phase 2 Study With Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (BL-8040), and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma","Inclusion criteria:\n\n1. Histological or pathological confirmation of metastatic pancreas adenocarcinoma\n\n   1. Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-treatment biopsy, prior to initiation of any study-related therapy.\n   2. Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy.\n   3. Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. Age ≥18 years\n4. Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment):\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL without granulocyte colony-stimulating factor support\n   2. White Blood Cell Count (WBC) count ≥ 2.5 x 109 \u002FL (2500\u002FuL)\n   3. Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FuL)\n   4. Platelet count ≥ 100 x 109\u002FL (100,000\u002FuL) without transfusion\n   5. Hgb ≥ 9.0 g\u002FdL\n   6. Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) ≤ 2.5X upper limit of normal (ULN), unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to initiation of therapy\n   7. Serum total bilirubin ≤ 1.5X ULN, unless in patients with known Gilbert disease (≤ 3X ULN), or unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to administration of investigational therapy\n   8. Albumin ≥ 3.5 g\u002FdL\n   9. Creatinine within ULN or calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin using the Cockcroft-Gault formula\n   10. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5X ULN, except for those on stable anticoagulation for at least two weeks\n5. Measurable disease according to Immune Modified (IM)-RECIST and tumor accessible for fresh biopsy\n6. Negative pregnancy test: Women of child-bearing potential must have a negative serum pregnancy test at screening and must agree to use an effective form of contraception from the time of the negative pregnancy test until a minimum of 3 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive (injectable or implantable) in conjunction with a barrier method. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.\n7. Birth control agreement: Fertile men must agree to use an effective method of birth control with female partners of childbearing potential (condoms plus an additional contraceptive method such as an injectable or implantable hormonal contraceptive) during the study and for up to 3 months after the last dose of study drug.\n8. Informed consent: Participants must be willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.\n9. Ability to comply: Participants must be able to comply with the study protocol, according to the investigator's judgement.\n10. DVT testing Participants must have undergone lower extremity dopplers to rule out deep venous thrombosis (DVT) within the screening period, and undergo therapeutic anticoagulation if evidence of DVT is identified.\n11. Anticoagulation treatment Subjects who are stable on full-dose anticoagulation medication for at least 2 weeks are considered eligible. However, subjects who have an increased clot burden on full-dose anticoagulation, such as central pulmonary embolism, or peripheral pulmonary embolism, and DVT within the extremities will be considered eligible only with the approval of the Principal Investigator.\n\nExclusion criteria:\n\n1. Prior systemic therapy for PDAC: Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies) prior to initiation of study treatment.\n2. Prior radiation therapy for PDAC Participants may not have had radiation therapy to within two weeks prior to initiation of study treatment. Participants may not have had previous radiotherapy to the primary pancreas lesion or a metastatic site except for palliation for pain. Participants who receive radiation to 25% or more of the bone marrow will be excluded.\n3. Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment\n4. Patients currently receiving any other investigational agents\n5. Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 or better, with the exception of alopecia of any grade and Grade ≤ 2 peripheral neuropathy\n6. Concomitant treatment with other anti-neoplastic agents (hormone therapy acceptable)\n7. Uncontrolled pleural effusion, pericardial effusion, or ascites. Subjects who required drainage within the four weeks prior or require pleural, pericardial, or peritoneal catheters for drainage are ineligible.\n8. Uncontrolled tumor-related pain Patients requiring narcotic pain medication must be on a stable regimen for at least two weeks prior to study entry.\n9. History of leptomeningeal or brain\u002F Central Nervous System (CNS) metastases\n10. Uncontrolled hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.\n11. Recent major surgery or significant traumatic injury Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment, or be recovering from procedure related adverse events of \\> Grade 1.\n12. Active or history of autoimmune disease or immune deficiency Includes, but is not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's 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 stable thyroid-replacement hormone for the past three months are eligible for the study.\n    2. Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen for the past month 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 \\\u003C10% 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.\n13. History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan (history of radiation pneumonitis or fibrosis in the radiation field is permitted).\n14. Positive for HIV at screening or any time prior to screening Patients without prior positive HIV test result will undergo an HIV test at screening, unless not permitted under local regulations.\n15. Hepatitis B virus (HBV) infection (chronic or acute) Defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study.\n16. Active hepatitis C virus (HCV) infection: Defined as positive HCV antibody test followed by a positive HCV RNA test at screening.\n\n    The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n17. Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease.\n18. Active tuberculosis\n19. Infection: Patients may not have had a severe infection requiring antibiotic treatment within the two weeks prior to initiation of study treatment. This includes, but is not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. However, patients who were admitted for biliary tract infection due to bile duct obstruction at time of diagnosis must have a functioning biliary stent (as evidenced by declining total bilirubin and ≤ 2X ULN) and resolved infection (defined by normalization of elevated white blood cell count, absence of signs of infection) and completion of an antibiotic course (at least a seven-day course) prior to initiation of therapy. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n20. Significant cardiovascular disease: Patient may not have significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, seizure disorder, uncontrolled hypertension, or unstable arrhythmia or unstable angina within 3 months prior to initiation of study treatment.\n21. Left ventricular ejection fraction below institutional lower limit of normal or below 50%, whichever is lower.\n22. Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)\n23. Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment\n24. Prior autologous stem cell, allogeneic stem cell, or solid organ transplantation\n25. History of other malignancy Patient may not have a history of malignancy other than PDAC within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5- year overall survival of \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n26. Recent vaccination: Patients may not have been treated with a live, attenuated vaccine within four weeks prior to initiation of study treatment, or anticipate the need for such a vaccine during treatment with cemiplimab or within five months after the last dose of cemiplimab.\n27. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n28. Known allergy or hypersensitivity to any of the study drug excipients\n29. Recent immunosuppressive treatment: Patients may not have been treated with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor alpha agents) within two weeks prior to initiation of study treatment, or anticipate the need for systemic immunosuppressive medication during the course of the study, with the following exceptions:\n\n    a. Patients who received a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after approval from the Principal Investigator.\n30. Pregnancy: Pregnant women are excluded from this study because there is an unknown, but potential risk for adverse events to the fetus. Breastfeeding should be discontinued prior to start of treatment because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment.\n31. Other contraindicated conditions Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator.\n32. Uncontrolled psoriasis, porphyria, proximal myopathy or neuropathy\n33. Severe depression Subjects hospitalized for depression within the past two years, or who have prior suicidal attempts will be excluded.\n34. Has received transfusions of blood products (including platelets or red blood cells) within 4 weeks prior to study Day 1.\n35. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study if receiving equivalent to ≤ 10 mg of prednisone daily (10mg prednisone is equivalent to either cortisone - 50mg; hydrocortisone - 40mg; triamcinolone - 8mg; prednisolone - 10mg; methylprednisolone - 8mg; betamethasone - 1.5mg; or dexamethasone - 1.5mg). Patients receiving \\> 10 mg of prednisone or equivalent per day for greater than five days within 28 days of starting study related therapy are not eligible. Steroids administered prior to gemcitabine and nab-paclitaxel should be administered as per standard institutional guidelines.",{"count":326,"type":21},[24],"The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.",[443,444,27],"Pancreatic Cancer","Adenocarcinoma of the Pancreas","2025-06-16",{"date":447,"type":39},"2025-06-19",{"date":449,"type":39},"2020-11-09",{"date":451,"type":21},"2028-08",{"name":453,"class":178},"Gulam Manji",3,{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":462,"sex":68,"minAge":463,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":278,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":47},"100283764","primer-development-of-daily-online-magnetic-resonance-imaging-for-magnetic-resonance-image-guided-radiotherapy-100283764","NCT02973828","PRIMER: Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy","Development of Daily Online Magnetic Resonance Imaging for Magnetic Resonance Image Guided Radiotherapy (MRIgRT)","Inclusion Criteria:\n\n* All volunteers must undergo and satisfy MRI safety screening\n* Non-patient volunteers must have no known (or suspected) significant medical condition and be 18 years of age\n* Patient volunteers must have histologically confirmed invasive carcinoma of the tumour\u002Ftarget sites listed in this protocol and be under the care of a Clinical Oncologist at the Royal Marsden NHS Foundation Trust or The Christie NHS Foundation Trust and patients be planned to receive radiotherapy to target site to be imaged\n* All volunteers must be willing and able to provide informed consent\u002Fassent for the study\n* Paediatric patient volunteers between the ages of 3 and 18 years, will have consent provided by his or her legal guardian who is 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nExclusion Criteria:\n\nAny conditions that would be a contra-indication to MRI including:\n\n* Failure to satisfy the MRI safety screening\n* Implanted pacemakers and\u002For pacing wires\n* Cochlear implants\n* Programmable hydrocephalus shunts\n* Implanted neurostimulation systems\n* Implanted drug infusion pumps\n* Ferromagnetic implants And additional conditions that may place volunteers at increased risk from MRI procedures including:\n* Known susceptibility to seizures or migraines\n* Fever, reduced thermal regulatory capabilities or increased sensitivity to raised body temperature (for example pregnant women)",true,"3 Years",{"count":465,"type":21},173,"In radiotherapy high-tech scans with x-rays (CT scans) are taken before and during treatment to locate the tumour and ensure the radiation is hitting the target.\n\nThese x-rays expose patients to additional radiation and the quality of these scans is often poor which makes it difficult to distinguish tumour from normal tissue and there may be uncertainty in the tumour position due to movement or shrinkage. To allow for these uncertainties a large margin around the tumour is also treated, but this means that large volumes of normal tissue also receive significant doses of radiation, which can result in early and late toxicity.\n\nMRI (magnetic resonance imaging) is better than CT scanning at being able to tell the difference between tumour and normal tissues and does not expose patients to additional radiation. A new machine called an MR Linac (or magnetic resonance imaging-guided linear accelerator) integrates high quality MRI with a state-of-the-art radiotherapy machine and the Institute of Cancer Research (ICR)\u002FThe Royal Marsden Hospital (RMH) are currently installation a prototype, which will be one of the first in the world. This revolutionary technology has the potential to change the way radiotherapy is delivered. We hope the improved precision and accuracy in hitting the target will mean reductions in margins around tumours and that this will lead to higher cure rates with significantly fewer side effects. Studies are required to simulate treatment on the MR Linac before it can be used in routine clinical practice and to conduct these studies, we need to obtain MRI scans on volunteers and patients who are currently undergoing treatment. This study will involve imaging with MRI in healthy volunteers as well as in patient volunteers before and during their standard course of radiotherapy to allow us to develop MRI sequences derived on the MR Linac for MR Linac-based research focusing on clinical application and establishment into a MR-CT and MR only workflow, treatment adaptation and quality assurance.",[27],"2025-05-01",{"date":470,"type":39},"2025-05-06",{"date":472,"type":39},"2017-10-17",{"date":474,"type":21},"2026-12-31",{"name":476,"class":178},"Institute of Cancer Research, United Kingdom",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":278,"phases":4,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":351},"100391222","serum-bank-for-pancreatic-cancer-100391222","NCT04374175","SERum-bank for PANcreatic Cancer","SERPAN","ADENOCARCINOMA GROUP\n\nInclusion Criteria:\n\n* Documented adenocarcinoma (cytology \u002F anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.\n* At the start of treatment (before surgery \u002F 1st course of chemotherapy)\n* Age ≥ 18 years\n* Patient affiliated or entitled to a social security system\n\nExclusion Criteria:\n\n* Patient refusal\n* Acute renal failure\n* Child-Pugh B or C cirrhosis\n* Patient under guardianship or curators\n* Other synchronous cancer or history of cancer \\\u003C5 years\n* Language barrier\n\nCONTROL GROUP\n\nInclusion Criteria:\n\n* Age ≥ 40 years\n* Patient affiliated or entitled to a social security system\n* Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease\n\nExclusion Criteria:\n\n* Patient refusal\n* Acute renal failure\n* Child-Pugh B or C cirrhosis\n* Patient under guardianship or curators\n* Other synchronous cancer or history of cancer \\\u003C5 years",{"count":485,"type":21},400,"This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (\\\u003C2cm), the chances of recovery are very good.\n\nBut the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.\n\nToday, there is no any effective means of detection... Blood markers can be a simple means of early detection",[27],[27,489,490,491],"Pancreatic cancer","Adiponectin","Blood sample","2025-03-17",{"date":494,"type":39},"2025-03-18",{"date":496,"type":39},"2020-04-01",{"date":498,"type":21},"2026-01-01",{"name":500,"class":178},"Centre Hospitalier Universitaire de Saint Etienne",{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":517,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":47},"100565999","evaluation-in-humans-of-the-correlation-between-hepatotoxicity-neurotoxicity-induced-by-oxaliplatin-and-blood-levels-of-hmgb1-100565999","NCT06649474","Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1","HEPATOXALI","Inclusion Criteria:\n\n* ECOG WHO Performance status = 0 or 1\n* Signed and dated informed consent\n* Patients with histological diagnosis of oesogastric or pancreatic adenocarcinoma\n* Resectable tumors\n* Patients able to have a laparoscopy\n* In case of absence of peritoneal invasion on the laparoscopy, patient candidate to a chemotherapy schedule by FLOT or FOLFOX in perioperative setting for oesogastric adenocarcinoma, or FOLFIRINOX in perioperative setting for pancreatic adenocarcinoma\n* Registration in a national health care system (CMU included)\n* Patient speak and understand the french\n\nExclusion Criteria:\n\n* Histology other than adenocarcinoma\n* Metastatic disease\n* History of previous treatment with oxaliplatine\n* History of systemic chemotherapy administration within 5 years prior to inclusion,\n* Patient with an non balanced progressive condition\u002Fdisease (liver failure, renal failure (creatinine clearance \\<30mL\u002Fmin), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months, etc.),\n* Patient on curative dose anticoagulant,\n* Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng\u002Fml),\n* Patient not operable for the pathology concerned,\n* Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure,\n* Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice),\n* Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and\u002For comply with the requirements of the study,,\n* Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy",{"count":509,"type":21},100,[222],"Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration.\n\nThe biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway.\n\nTherefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.",[443,513,27,514,515,516],"Resectable Pancreatic Adenocarcinoma","Resectable Esophageal Cancer","Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","Oesophagogastric Cancer",[518,519,520],"resecable pancreatic, oesophageal, gastric or gastroesophageal junction adenocarcinoma.","Patients able to have a laparoscopy","chemotherapy before surgery","2024-10-17",{"date":523,"type":39},"2024-10-18",{"date":525,"type":39},"2024-09-06",{"date":527,"type":21},"2028-06-30",{"name":529,"class":178},"University Hospital, Clermont-Ferrand",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":68,"minAge":537,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":251},"100231592","beyond-tme-origins-100231592","NCT02292641","Beyond TME Origins","Investigating the Origins of Pelvic Recurrence in Colorectal Cancer","Inclusion Criteria:\n\n1. Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice\n2. Has a confirmed diagnosis of recurrent pelvic colorectal cancer\n3. Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum\n4. Are able to undergo high resolution MRI for staging prior to treatment decisions\n5. Have provided written informed consent to participate in the study\n6. Be aged 16 years or over\n\nExclusion Criteria:\n\n1. Have irresectable extra-pelvic metastatic disease\n2. Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and\u002For CT for colon and sigmoid cancers) are unavailable\n3. Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable","16 Years",{"count":539,"type":21},383,[222],"All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.",[29,27,30],[544,545,258,546,547,29,27,30],"Lower Gastrointestinal Tract","Rectum","Magnetic Resonance Imaging","Pelvic Exenteration","2024-10-16",{"date":521,"type":39},{"date":551,"type":39},"2014-09-25",{"date":553,"type":21},"2031-12",{"name":430,"class":178},{"id":556,"slug":557,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":278,"phases":4,"briefSummary":566,"conditions":567,"keywords":569,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":47},"100542045","young-adults-with-gastro-intestinal-gi-and-neuroendocrine-cancers-100542045","NCT06337760","YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.","YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs (YOUNGSTER).","YOUNGSTER","Inclusion Criteria:\n\n* Age at diagnosis from18 to 39 years of age\n* Carcinoma (without limitations for histologic subtypes) from any primary sites: esophagus, stomach, pancreas, biliary tract, liver, small bowel, colon, rectum, anus and cancer of unknown origin\n* Neuroendocrine neoplasm (NEN) from Gastroenteropancreatic GEP or lung\u002Fthymus origin\n* Tumors at any stage at the first visit\n* Tumors of any grade\n* Histological diagnosis obtained within two years from the time of enrollment or willingness to undergo bioptic procedure for diagnosis\n\nExclusion Criteria:\n\n* Age at diagnosis \\> 39 years old","39 Years",{"count":565,"type":21},90,"The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition \"adolescent and young adults (AYA)\" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available.",[568,27],"Neuroendocrine Neoplasm",[570,571,572,573,574],"young adult","Gastro-intestinal cancer","Neuroendocrine cancer","molecular analysis","prognostic biomarker","2024-03-22",{"date":577,"type":39},"2024-03-29",{"date":579,"type":39},"2023-03-10",{"date":581,"type":21},"2027-06-30",{"name":583,"class":178},"European Institute of Oncology",{"id":585,"slug":586,"hasResults":11,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":218,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":47},"100534641","phase-2-efficacy-and-safety-of-sintilimab-combined-with-nab-paclitaxel-and-tegio-ats-as-first-line-treatment-of-unresectable-locally-advanced-recurrent-or-metastatic-adenocarcinoma-of-gastric-and-gastroesophageal-junctiona-phase-ii-clinical-study-100534641","NCT06241469","Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction，a Phase II Clinical Study","Efficacy and Safety of Sintilimab Combined With Nab-paclitaxel and Tegio (aTS) as First-line Treatment of Unresectable Locally Advanced, Recurrent or Metastatic Adenocarcinoma of Gastric and Gastroesophageal Junction (CZTU-1)：a Phase II Clinical Study","Inclusion Criteria:\n\n1. Non resectable locally advanced, recurrent, or metastatic adenocarcinoma at the junction of the stomach and esophagus (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination.\n2. Age ≥ 18 years old.\n3. The ECOG PS score is 0 or 1.\n4. The time from the end of previous (new) adjuvant chemotherapy\u002Fradiotherapy to disease recurrence is greater than 6 months.\n5. Palliative treatment for local lesions (non target lesions) should last for more than 2 weeks until randomization.\n6. According to RECIST v1.1, there should be at least one measurable or evaluable lesion.\n7. Can provide archived or fresh pathological tissues within 6 months from the signing of the informed consent document for PD-L1 testing and obtain test results.\n8. Having sufficient organ and bone marrow functions, defined as follows:\n\n1\\) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT)≥ 100 × 109\u002FL; Hemoglobin content (HGB) ≥ 8.0 g\u002FdL. No G-CSF, GM-CSF, Meg CSF, TPO, EPO, red blood cell transfusions or platelet transfusions were not used within the first 7 days of the examination.\n\n2\\) Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Patients with liver metastasis require serum total bilirubin (TBIL) ≤ 1.5 × Normal upper limit (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN.\n\n3\\) Renal function: Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin(Calculate using the CKD-EPI formula) 4) Adequate coagulation function is defined as an international standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the range of anticoagulant drugs prescribed; 5) Urinary routine: Urinary protein\\\u003C2+; If the urine protein is ≥ 2+, the 24-hour urine protein quantification needs to be\\\u003C1.0 g.\n\n9\\. Expected survival time ≥ 24 weeks. 10. Female participants of childbearing age or male participants whose sexual partners are female participants of childbearing age are required to take effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\n11\\. Sign a written informed consent form and be able to comply with the visitation and related procedures stipulated in the plan.\n\nExclusion Criteria:\n\n1. Known signs of active bleeding in the lesion (excluding positive fecal occult blood).\n2. Obstruction of the cardia and pylorus can affect the patient's eating and gastric emptying, or hinder the swallowing of medication.\n3. Diagnosed as HER2 positive adenocarcinoma at the junction of the stomach and esophagus.\n4. Previously received systematic treatment for advanced or metastatic adenocarcinoma at the junction of the stomach and esophagus.\n5. Peripheral neurotoxicity has not recovered to level 1 after previous treatment.\n6. It is known that dihydropyrimidine dehydrogenase (DPD) is deficient (or has experienced mucosal toxicity of grade 3 or higher in previous fluorouracil containing treatments).\n7. Known to be allergic to any monoclonal antibody or chemotherapy drug (tigio, albumin bound paclitaxel) formulation component (having experienced grade 3 or above allergic reactions).\n8. Previously exposed to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug targeting T cell co stimulation or checkpoint pathways.\n9. Participate in another intervention clinical study at the same time, unless participating in an observational (non intervention) clinical study or in the follow-up stage of an intervention study.\n10. Within 2 weeks before the first administration, systemic systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor indications has been received;\n11. Within 4 weeks prior to the first dose of study treatment, immunosuppressive drugs were used, excluding local corticosteroids administered through nasal spray, inhalation, or other routes, or systemic corticosteroids administered at physiological doses (i.e. no more than 10 mg\u002Fday of prednisone or equivalent doses of other corticosteroids), or steroids were used to prevent contrast agent allergies.\n12. Within 4 weeks prior to the first dose of study treatment or planned to receive attenuated live vaccines during the study period.\n\n    Note: It is allowed to receive inactivated viral vaccines for seasonal influenza within 4 weeks before the first administration; But it is not allowed to receive attenuated live influenza vaccines;\n13. Have undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or are expected to require major surgery during the study treatment period; Laparoscopic exploration surgery was performed within 2 weeks prior to the first dose of study treatment.\n14. Toxicity (excluding hair loss, non clinically significant, and asymptomatic laboratory abnormalities) at level 0 or 1 of the National Cancer Institute Common Standard Terminology 5.0 (NCI CTCAE v5.0) caused by previous anti-tumor treatments prior to the initial study treatment.\n15. It is known that there are symptomatic central nervous system metastases and\u002For cancerous meningitis. For subjects with brain metastases who have received previous treatment, if their condition is stable (no evidence of imaging progression at least 4 weeks prior to the first administration of the trial treatment, and repeated imaging examinations confirm no evidence of new or enlarged brain metastases), and they do not require steroid treatment for at least 14 days prior to the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its stable clinical condition.\n16. Any ascites that can be detected during physical examination, ascites that have been previously treated or still require treatment, with only a small amount of ascites shown on imaging but no symptoms, can be selected.\n17. Patients with equal amount of fluid accumulation in both sides of the chest cavity, or a large amount of fluid accumulation in one side of the chest cavity, or those who have caused respiratory dysfunction and require drainage.\n18. Patients with bone metastases who are at risk of paralysis.\n19. Known or suspected autoimmune disease or medical history of the disease in the past two years (vitiligo, psoriasis, alopecia or Grave's disease that does not need systematic treatment in the past two years, hypothyroidism that only needs thyroid hormone replacement therapy and type I diabetes patients that only need insulin replacement therapy can be included in the group).\n20. Known history of primary immunodeficiency.\n21. Known to have active pulmonary tuberculosis.\n22. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n23. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive).\n24. Severe infections that are active or poorly controlled clinically.\n25. Symptomatic congestive heart failure (New York Heart Association classification II-IV) or symptomatic or poorly controlled arrhythmia.\n26. Uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) even after receiving standardized treatment.\n27. Have experienced any arterial thromboembolism events, including myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks, within the 6 months prior to enrollment for treatment.\n28. Significant malnutrition (a weight loss of 5% within 1 month of signing the informed consent form, a weight loss of\\>15% within 3 months, or a decrease of 1\u002F2 or more in food intake within 1 week), except for malnutrition correction of more than 4 weeks before the first dose of study drug administration.\n29. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the 3 months prior to enrollment (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered \"severe\" thromboembolism).\n30. Uncontrolled metabolic disorders or other non malignant organ or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and\u002For uncertainty in survival evaluation.\n31. Hepatoencephalopathy, hepatorenal syndrome, or Child Pugh B grade or more severe cirrhosis.\n32. History of tumor related intestinal obstruction (within 3 months prior to the signing of informed consent) or the following diseases: inflammatory bowel disease or extensive bowel resection (partial or extensive bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis.\n33. Known to have acute or chronic active hepatitis B virus (HBsAg positive and HBV DNA viral load ≥ 200 IU\u002FmL or ≥ 103 copy number\u002FmL) or acute or chronic active hepatitis C virus (HCV antibody positive and HCV RNA positive).\n34. Active syphilis infected individuals who require treatment.\n35. There is a history of gastrointestinal perforation and\u002For fistula within the 6 months prior to enrollment in the study, except for patients with gastric cancer perforation who have undergone surgical resection of the primary lesion of gastric cancer.\n36. Suffering from interstitial lung disease that requires steroid hormone treatment.\n37. History of other primary malignant tumors, excluding:\n\n    * Complete remission (CR) of malignant tumors for at least 2 years prior to enrollment and no additional treatment required during the study period;\n    * Non melanoma skin cancer or malignant freckle like nevi that have been adequately treated and have no evidence of disease recurrence;\n    * In situ cancer with sufficient treatment and no evidence of disease recurrence.\n38. Pregnant or breastfeeding female patients.\n39. Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to increased risk of study participation or drug administration, or interference with the interpretation of study results, and the inclusion of patients as ineligible to participate in this study based on the researcher's judgment.",{"count":592,"type":21},40,[24],"The goal of this clinical trial is to find better protocal for adenocarcinoma of the gastric and gastroesophageal juncion.\n\nThe main question is aim to answer is:\n\n1\\. The efficacy and safety of PD-1 monoclonal antibody (Sintilimab) combined with nab-paclitaxel and S-1 in the first-line treatment of advanced gastric and gastroesophageal junction adenocarcinoma.\n\nParticipants will be given PD-1 monoclonal antibody, nab-paclitaxel and tegio.",[390,391,27],"2024-01-28",{"date":598,"type":39},"2024-02-05",{"date":600,"type":21},"2024-02-03",{"date":602,"type":21},"2027-02-02",{"name":604,"class":178},"Wu Jun",{"id":606,"slug":607,"hasResults":11,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":68,"minAge":17,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":625,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":47},"100525435","phase-2-radiotherapy--chemoimmunotherapy-followed-by-surgery-in-patients-with-limited-metastatic-gastric-or-gej-cancer-100525435","NCT06121700","Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer","Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial","Miracle-G","Inclusion Criteria:\n\n1. Histopathologically confirmed adenocarcinoma of stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).\n2. Limited metastatic status of disease.\n3. At least one evaluable lesion in CT\u002FMRI according to RESIST 1.1 is required.\n4. The status of HER2 is clear.\n5. pMMR\u002FMSS confirmed by immunohistochemistry or gene test.\n6. Male or female. Patient age ≥ 18 years and ≤ 75 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n8. Physical state or organ function can tolerate the planned treatment of the study protocol, including systematic chemotherapy, immunotherapy with anti-PD-1 monoclonal antibody (mAb), primary lesion radiotherapy, metastatic lesion radiotherapy, and surgical resection of primary and\u002For metastatic lesions.\n9. No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.\n10. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count ≥ 100×109\u002FL; hemoglobin level ≥ 90 g\u002FL.\n11. Adequate hepatic function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases; ALP ≤ 2.5×ULN; ALB ≥ 30 g\u002FL.\n12. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml\u002Fmin.\n13. Adequate coagulation function: INR\u002FPT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.\n14. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. 13. If the level of T3\u002FT4 is normal, the patients can be selected.\n15. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g.\n16. There is no serious concomitant disease, and the patient's life expectancy is more than 6 months.\n17. Patients agree to sign written informed consent before recruitment.\n18. Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n19. Patients are willing to provide samples of blood and tissue.\n20. Female patients should not be pregnant or breast feeding.\n21. Female patients agree to take contraceptive measures during treatment and within 120 days after the last dose of anti-PD-1 mAb or 180 days after the last use of chemotherapy or radiotherapy.\n\nDefinition of the limited metastatic disease:\n\n1. Retroperitoneal lymph node metastases (RPLM) only or at maximum one organ involved with or without RPLM.\n2. There is no peritoneal seeding on diagnostic laparoscopy (P0).\n3. The definition of RPLM includes but is not limited to para-aortal, intra-aorto-caval, parapancreatic or mesenteric lymph nodes. If the duodenum is invaded, retropancreatic nodes are not regarded as M1.\n4. The definition of single organ metastasis in the study is as follows: a) Liver: maximum of 5 metastatic lesions that are potentially resectable and the metastases should be limited to one lobe and not involve important blood vessels or bile ducts. b) Lung: unilateral involvement, potentially resectable. c) Ovary: uni- or bilateral Krukenberg tumors in the absence of macroscopic peritoneal carcinomatosis. d) Adrenal gland: uni- or bilateral metastases. e) Extra-abdominal lymph node metastases, such as supraclavicular or cervical lymph node involvement. f) Bone: localized bone involvement (defined as being within one radiation field).\n5. Other metastatic disease locations are considered, limited by the investigator and confirmed by the multidisciplinary team (MDT).\n\nExclusion Criteria:\n\n1. Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.\n2. Patients have a history of cancer in the five years before enrollment except for squamous or basal cell carcinoma of the skin that was effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that was treated by operation.\n3. Pregnant or lactating females or females planning to become pregnant or lactating. Women of childbearing age with a positive pregnancy test or without a pregnancy test in the baseline period. Menopausal women must have stopped menstruating for at least 12 months before being considered to have no chance of pregnancy.\n4. Patients who had sexual activity (with the possibility of childbirth) and were unwilling to use contraception during the study period.\n5. Patients with a history of allergies to any drugs that may be used in this study, including chemotherapy drugs.\n6. History of allogeneic stem cell transplantation or organ transplantation.\n7. Vaccinated with live vaccine within 28 days before recruitment.\n8. Immunotherapy (interleukin, interferon, thymine) or other experimental treatment was given 28 days before enrollment.\n9. History of anti-PD-1, PD-L1, PD-L2 or any other specific T-cell costimulation or checkpoint pathway targeted therapy.\n10. History of using steroids (dose \\> 10 mg\u002Fd prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose \\> 10 mg\u002Fd prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.\n11. Patients with weight loss of more than 20% within 2 months before recruitment.\n12. Uncontrolled systemic diseases, including diabetes, hypertension, etc.\n13. Uncontrollable pleural effusion, pericardial effusion, or ascites occurred within two weeks before recruitment.\n14. Failure of important organs (heart, lung, liver, kidney, etc.).\n15. Moderate or severe renal injury \\[creatinine clearance ≤ 50 ml\u002Fmin (according to Cockcroft \\& Gault equation)\\], or SCR \\> ULN.\n16. Dipyrimidine dehydrogenase (DPD) deficiency.\n17. Patients with central nervous system (CNS) disorders or tumors, including brain metastases, peripheral nervous system disorders or psychiatric diseases.\n18. Cerebrovascular accidents occurred within 6 months before recruitment.\n19. Patients with peripheral neuropathy of NCI-CTCAE grade 1, except for those with disappearance of the deep tendon reflex.\n20. Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction or cardiac insufficiency within 6 months prior to study recruitment.\n21. Pulmonary embolism occurred within 28 days before enrollment.\n22. Patients who had the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or acute lung disease.\n23. Patients with gastrointestinal bleeding or a high risk of bleeding within the first 2 weeks of enrollment.\n24. Patients who experienced gastrointestinal perforation or fistula within 6 months prior to enrollment.\n25. Upper gastrointestinal obstruction, dysfunction or malabsorption syndrome may affect the absorption of oral chemotherapy drugs.\n26. Patients who cannot swallow or take medication orally.\n27. Patients with a history of active autoimmune disease or refractory autoimmune disease.\n28. Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.\n29. Known history of human immunodeficiency virus (HIV) infection.\n30. Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU\u002Fml or HCV-RNA positive.\n31. Alcohol\u002Fdrug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results.","75 Years",{"count":615,"type":21},55,[24],"The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients.\n\nParticipants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+\u002FISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.",[27,619,620,621,255,622,623,367,624],"Stomach Neoplasm","Gastroesophageal-junction Cancer","Oligometastatic Disease","Metastatic Gastric Cancer","Adenocarcinoma of the Stomach","Metastatic Adenocarcinoma",[626,627,628,629,630,631,632,633],"gastric cancer","GEJ Cancer","oligometastasis","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","metastasectomy","2023-11-07",{"date":636,"type":39},"2023-11-08",{"date":638,"type":39},"2023-01-01",{"date":640,"type":21},"2027-12-31",{"name":642,"class":178},"Fudan University"]