[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Center Eugene Marquis\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":269},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,43,67,96,123,148,172,197,219,244],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100636807","feasibility-assessment-of-adapted-physical-activity-in-patients-treated-for-a-brain-tumor-100636807",false,"NCT07570485","Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor","APATC","Inclusion Criteria:\n\n* Men or women ≥ 18 years old,\n* Receiving medical oncology treatment at the CLCC Eugène Marquis,\n* Diagnosed with a primary brain tumour, regardless of diagnosis, grade or treatment,\n* Possible motor, sensory, attention, concentration, or memory deficits,\n* Patients who accept the general terms of use for connected watches\n* Patients affiliated with or covered by the French social security system,\n* Patients who have received information and signed informed consent (or their legal representative),\n\nExclusion Criteria:\n\n* WHO score ≥ 3\n* Comprehension disorders that prevent participation in adapted physical activity\n* Pregnant or breastfeeding women\n* Patients without the necessary devices to use a smartwatch (smartphone, tablet or computer),\n* Patients deprived of liberty, under guardianship, or curatorship, or subject to any other administrative safeguard measure.\n\nPatients unable to comply with the study schedule for social, medical, or psychological reasons.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to assess the feasibility of an adapted physical activity (APA) program in adult patients (≥18 years) with primary brain tumors, regardless of tumor type, grade, treatment stage, or the presence of motor, sensory, attention, concentration, or memory deficits.\n\nThe main question it aims to answer is:\n\nWhat is the effective adherence rate to an APA program among eligible patients with primary brain tumors?\n\nAdditional questions include:\n\n* What is the observance rate (number of sessions completed, intensity achieved, and duration) during the 3-month supervised APA program?\n* What is the retention rate (proportion of patients completing the program and continuing APA beyond the initial period)?\n* What is the impact of APA on quality of life, anxiety-depression, and cancer-related symptoms (measured via QLQ-BN20, HADS, and MFI-20 questionnaires at baseline, 3, and 4 months)?\n\nParticipants will:\n\n* Undergo a 3-month supervised APA program (with possible continuation beyond this period).\n* Use connected watches to monitor physical activity (if they accept the general conditions of use).\n* Complete self-questionnaires (IPAQ, BREQ-2, QPP, QLQ-BN20, HADS, MFI-20) at inclusion, 3 months, and 4 months.\n* Be followed for a total of 4 months after inclusion.",[26],"Brain Tumor Adult",[28,29],"Brain Tumor","Adapted physical activity (APA)","NOT_YET_RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":20},"2026-06-01",{"date":38,"type":20},"2028-06-01",{"name":40,"class":41},"Center Eugene Marquis","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100636810","predicting-response-to-immunochemotherapy-in-early-triple-negative-breast-cancer-100636810","NCT07570524","Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer","PRIME-TNBC","Inclusion Criteria:\n\n* Female.\n* Age ≥ 18 years.\n* Histologically confirmed invasive triple-negative breast cancer (ER and PR \\\u003C 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.\n* Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.\n\nIndication for intra-tumoral clip placement.\n\n\\- Signed written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Hematoma requiring Grade II analgesics after diagnostic biopsy.\n* Known coagulation disorders.\n* Adults under guardianship, curatorship, or legal protection, or deprived of liberty.\n* Not affiliated with a social security system.","FEMALE",{"count":52,"type":20},200,"OBSERVATIONAL","The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:\n\n* Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial\u002Fnon-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?\n* Are there specific immune or molecular biomarkers (e.g., TILs, CD3\u002F8\u002F20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.",[56],"Triple-negative Breast Cancer (TNBC)",[58,59],"Biopsy","Residual Cancer Burden score","2026-04-30",{"date":62,"type":34},"2026-05-06",{"date":36,"type":20},{"date":65,"type":20},"2036-05-31",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"100607518","phase-iii-adaptive-adaptive-stereostactic-body-radiotherapy-sbrt-with-dose-escalation-for-high-risk-prostate-cancer-100607518","NCT07189598","Phase III Adaptive Adaptive Stereostactic Body Radiotherapy (SBRT) With Dose Escalation for High-Risk Prostate Cancer","Phase III Study of Adaptive Stereostactic Body Radiotherapy With Dose-escalation on the Dominant Intraprostatic Lesion for High-risk Prostate Cancer: ORION Trial Protocol","ORION","Inclusion Criteria:\n\n* Male.\n* Age ≥ 18 years\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n* Histologically proven prostate adenocarcinoma, not previously treated\n* High-risk or very high-risk according to the National Comprehensive Cancer Network (NCCN) :\n\n  * T3a \u002F T3b (proximal extension only),\n  * and\u002For ISUP (International Society of Urological Pathology) grade 4-5,\n  * and\u002For PSA (Prostate-Specific Antigen) 20ng\u002FmL\n* Non-metastatic, as proven by Prostate Specific Membrane Antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and pelvic MRI (Magnetic Resonance Imaging) less than 2 months before starting hormone therapy\n* Normal testosterone levels prior to hormone therapy\n* Ability to give consent for inclusion in the study\n* Acceptance of treatment and monitoring modalities\n\nExclusion Criteria:\n\n* Presence of nodal or distant metastases\n* Stage T4.\n* Prostate volume \\> 80 cm3.\n* IPSS \\>19\u002F35.\n* Previous local treatment of prostate adenocarcinoma (HIFU (High-Intensity Focused Ultrasound), cryotherapy)\n* Previous TransUrethral Resection of the prostate (PTUR)).\n* Previous pelvic radiotherapy.\n* Chronic inflammatory bowel disease.\n* Active cardiovascular comorbidities (e.g. myocardial infarction or ischemic stroke within the last 6 months).","MALE",{"count":77,"type":20},390,[23],"The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).",[81],"High Risk Prostate Cancer",[83,84,85,86,87],"phase III","stereotactic body radiotherapy","prostate cancer","high-risk","randomized clinical trial","RECRUITING","2026-04-29",{"date":60,"type":34},{"date":92,"type":34},"2026-03-02",{"date":94,"type":20},"2033-04-01",{"name":40,"class":41},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100602329","phase-2-evaluation-of-sirt-followed-by-immunotherapy-for-treatment-of-hepatocellular-carcinoma-with-portal-vein-thrombosis-100602329","NCT07122089","Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis","A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis","IOSPHERE","Inclusion Criteria:\n\n1. Age ≥ 18,\n2. ECOG Performance Status 0-1,\n3. Histologically proven HCC or noninvasive HCC diagnosis according to LiRADS criteria,\n4. HCC with Portal vein involvement (PVT), segmental, sectorial or lobar, evaluated by diagnostic imaging (CT scan or MRI),\n5. At least one measurable lesion≥ 10mm using mRECIST criteria evaluated by diagnostic imaging,\n6. Tumor involvement \\\u003C50% of the liver,\n7. Hepatic reserve after SIRT ≥ 30% (i.e. hepatic parenchyma not treated with SIRT) evaluated by diagnostic imaging\n8. No cirrhosis or Compensated cirrhosis (Child Pugh A, ALBI score 1 or 2),\n9. SIRT indication confirmed by a multidisciplinary team meeting (i.e. patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study),\n10. Registration with a social security scheme,\n11. Written and informed consent of the patient.\n\nExclusion Criteria:\n\n1. Patient with main PVT (partial or complete),\n2. Extrahepatic metastases (patients with EHS), except hilum node \\\u003C 2 cm,\n3. Previous episode of ascites and\u002For presence of ascites, even if only seen on imaging without clinical detection (except minimum blade only peri-hepatic),\n4. Previous episode of hepatic encephalopathy and\u002For hepatic encephalopathy presence at study entry and\u002For episodes of encephalopathy (Grade ≥2) within 6 months prior to study inclusion,\n5. Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of \\\u003C60 mmHg, or oxygen saturation (SaO2) of \\\u003C90% (Roussos \\& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD),\n6. Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality,\n7. Previous HCC therapies:\n\n   1. Any prior systemic treatment for HCC;\n   2. More than 2 prior TACE (or embolization), in the area to be treated;\n   3. Liver resection or ablation \\\u003C6 months from end of previous treatment to TheraSphere administration;\n   4. Liver ablation \\\u003C3 months from end of previous treatment to TheraSphere administration.\n8. Prior exposure to immune mediated therapy for HCC or other disease, such as other anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, antibodies, etc.\n9. Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT) or SIRT\n10. Inadequate hematological, hepatic and renal functions:\n\n    1. Hemoglobin \\\u003C8,5 g\u002Fdl;\n    2. Granulocytes \\\u003C1500\u002Fmm3;\n    3. Platelets \\\u003C 50 000 \u002Fmm3;\n    4. Bilirubin level ≥35 umol\u002Fl;\n    5. Albumin \\\u003C28g\u002FL;\n    6. Transaminases \\> 5 UNL;\n    7. Creatinine \\> 1,5 UNL;\n    8. INR\\>2 (or TP \\\u003C60%) without anti-coagulation.\n11. Any contraindication to angiography or selective visceral catheterization,\n12. History of any organ allograft, including bone marrow allo and autograft,\n13. History of active primary\u002Facquired immunodeficiency, that makes patients unsuitable for additional immunotherapy in this study (per investigator),\n14. Active or prior documented autoimmune or inflammatory disorders (including but not limited to inflammatory bowel disease \\[e.g. ulcerative colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia;\n    2. Patients with hypothyroidism (e.g. following Hashimoto's syndrome) stable on hormone replacement therapy;\n    3. Any chronic skin condition that does not require systemic therapy;\n    4. Patients with celiac disease controlled by diet alone.\n15. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection),\n16. In the case of background systemic corticosteroid use, doses of prednisone or its equivalent \\>10 mg\u002Fday,\n17. Need for premedication of hypersensitivity reactions with Steroids (e.g. CT scan premedication),\n18. History of gastrointestinal bleeding within 42 days prior to study inclusion, active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device). Patients with known varices that have not bled or which have been clinically addressed can enter the study. No endoscopic exploration is required before study inclusion,\n19. Presence of biliary stent or sphincterotomy within one year prior to study inclusion,\n20. History of malignancy, other than HCC, within two years, except the condition is one of the following:\n\n    1. Adequately treated carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, breast ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion;\n    2. Localized prostate cancer under active surveillance;\n    3. Other cancer when there is a negligible risk of recurrence or progression or death (5-year OS rate \\> 90%).\n21. Major surgical procedure (as defined by the Investigator) within 42 days prior to study inclusion,\n22. A history of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically,\n23. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients that cannot be managed medically,\n24. Active infection, including:\n\n    1. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice),\n    2. HBV\\* and Hep D co-infection,\n    3. Human immunodeficiency virus\\*\\* (HIV 1\u002F2 antibodies) plus HCV or HBV\\* co-infection.\n\n       * Patients with active HBV infection or HCV infection must be managed according to local standard of care. Patients must show evidence of viral disease stabilization prior to inclusion.\n\n         * Patients with Human Immunodeficiency Virus (HIV) infection are eligible, provided the HIV infection is well controlled with no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FµL\n25. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab and\u002For tremelimumab. Note: patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and\u002For tremelimumab and up to 30 days after the last dose of durvalumab and\u002For tremelimumab,\n26. Participation in another clinical trial in the 4 weeks prior to enrollment, unless it is an observational study or a 4-week no-treatment follow-up phase of an interventional study,\n27. Female patients who are pregnant (a negative serum pregnancy test is mandatory for inclusion) or breastfeeding and who do not want to stop breastfeeding. Male or female patients of reproductive potential who are not willing to employ any effective birth control method from screening and for at least 3 months post the last dose of study treatment (durvalumab ± tremelimumab and\u002For TheraSphere), whichever is later,\n28. Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere, durvalumab and tremelimumab treatment as deemed by the site principal investigator,\n29. Patients who are not able to follow the TheraSphere, durvalumab or tremelimumab treatment requirements,\n30. Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:\n\n    1. Persons receiving psychiatric treatment;\n    2. Persons admitted to a health or social establishment for purposes other than research;\n    3. Person of full age under curatorship;\n    4. Adult subject to a mandate for future protection, a family authorization, or a guardianship measure.\n\nAngiograhy and dosimetry exclusion criteria:\n\n1. Cone Beam CT (CBCT) or Technetium-99m Macro Aggregated Albumin (99mTc-MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques,\n2. 99mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor targeting and\u002For a poor portal vein thrombosis (PVT) targeting (99mTc-MAA uptake ≤ normal liver uptake),\n3. The dosimetry endpoints cannot be reached (refer to the supplement A \"TheraSphere Treatment Planning, Dosimetry Guidance document\"),\n4. Shunting of blood to the lungs that could result in delivery of \\>30 Gy to the lungs in a single treatment, or \\>50 Gy cumulative dose to the lungs in case of multiple TheraSphere treatments, as seen on 99mTc-MAA hepatic arterial perfusion scintigraphy.",{"count":105,"type":20},80,[107],"PHASE2","Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.\n\nFor advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.\n\nResults for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.\n\nSelective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.\n\nNowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.\n\nThe use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.\n\nSuch kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.\n\nThe aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.",[110],"Hepatocellular Carcinoma Non-resectable",[112,113,114],"Hepatocellular carcinoma","Immunotherapy","Selective internal radiation therapy",{"date":116,"type":34},"2026-05-05",{"date":118,"type":34},"2026-02-25",{"date":120,"type":20},"2030-01-02",{"name":40,"class":41},6,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100459637","phase-2-selective-internal-radiation-therapy-and-capecitabine-chemotherapy-treatment-for-liver-cancer-100459637","NCT05265208","Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer","A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlangiocarcinoma","SIROCHO","Inclusion Criteria:\n\n1. Age \\> 18 years-old,\n2. ECOG Performance Status \\\u003C2,\n3. Histologically-proven ICC,\n4. No previous treatment for ICC,\n5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,\n6. Significant risk of close margins, defined as:\n\n   1. Resection margin predicted by the surgeon \\\u003C1 cm\n   2. Tumour \\>5 cm\n   3. Multifocal lesion deemed resectable, validated by a Surgical Review Board\n7. Registration with a social security scheme,\n8. Patient information and signature of informed consent or legal representative.\n\nNon-inclusion Criteria:\n\n1. Severe fibrosis (F3) ou cirrhosis (F4),\n2. Inadequate haematological, hepatic, renal and coagulation functions:\n\n   1. Haemoglobin ≤ 8,5 g\u002Fdl\n   2. Neutrophils \\\u003C 1,5 Giga\u002FL\n   3. Platelets \\\u003C 60 Giga\u002FL\n   4. Bilirubin \\> 34 µmol\u002FL\n   5. ASAT\u002FALAT \\> 5 x ULN\n   6. Creatinine clearance \\\u003C 30 ml\u002Fmin (MDRD)\n   7. TP et INR \\> 2,3 ULN\n   8. TCA \\> 1,5 x ULN\n3. Uracil blood level \\>16 ng\u002FmL,\n4. Respiratory insufficiency,\n5. Comorbidity precluding surgical resection, such as severe heart disease,\n6. Presence of microvacuolar steatosis \\> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned,\n7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis),\n8. Previous chemotherapy (including for another cancer),\n9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer),\n10. Other invasive malignancies,\n11. Patient participate to an interventional study that tests another medical intervention before surgery,\n12. Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant,\n13. Minors, individual deprived of liberty, or under any kind of guardianship,\n14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.\n\nExclusion Criteria:\n\n1. Pulmonary shunt with dose \\>30Gy,\n2. Digestive shunting, non-correctible by interventional radiology,\n3. Absence of fixation of MAA in the tumour.",{"count":132,"type":20},62,[107],"Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\\\u003C5mm) margins having a higher risk of recurrence.\n\nSelective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics.\n\nGiven the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.",[136],"Resectable Intrahepatic Cholangiocarcinoma",[138],"Selective Internal Radiation Therapy","2025-08-05",{"date":141,"type":34},"2025-08-06",{"date":143,"type":34},"2022-02-04",{"date":145,"type":20},"2030-02-04",{"name":40,"class":41},7,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":42},"100560923","systematic-intervention-to-improve-sexual-dysfunction-100560923","NCT06583460","Systematic Intervention to Improve Sexual Dysfunction","Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients","SISTER","Inclusion Criteria:\n\n* Women ≥ 18 years (menopausal or not),\n* Localized breast cancer with or without lymph node involvement,\n* Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),\n* Patient affiliated or benefiting from the social security system,\n* Patient informed and informed consent signed.\n\nExclusion Criteria:\n\n* History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,\n* Pregnant or breast-feeding women,\n* Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,\n* Patients unable to comply with the study schedule for social, medical or psychological reasons.",{"count":157,"type":20},60,[23],"The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.",[161,162],"Breast Cancer Female","Localized Cancer",[164],"Sexual dysfunction","2025-08-04",{"date":139,"type":34},{"date":168,"type":34},"2024-12-09",{"date":170,"type":20},"2028-06-09",{"name":40,"class":41},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":122},"100558450","phase-2-microbiota-modification-for-immuno-oncology-in-hepatocellular-carcinoma-100558450","NCT06551272","Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma","MOTHER","Inclusion Criteria:\n\n1. Male and Female\n2. Age ≥18 years at time of signing informed consent\n3. Presenting with HCC, diagnosed either by histological or radiological criteria as described by EASL\n4. Locally advanced or metastatic and\u002For unresectable HCC according a Multidisciplinary Team meeting\n5. Progressive disease after exposure to standard-of-care approved first-line immunotherapy\n6. Decision made by the physician to continue the same standard-of-care approved first-line immunotherapy beyond progression\n7. Child-Pugh A within 7 days prior to inclusion\n8. ECOG performance status 0 to 1\n9. Adequate hematological (Hemoglobin \\>8.5g\u002FdL, platelets \\>60G\u002FL, neutrophils \\>1.5G\u002FL) and renal (creatinine clearance \\> 50 mL\u002Fmin according to Cockcroft or MDRD formula) functions\n10. Disease measurable by RECIST 1.1\n11. Signed written Informed consent\n\nExclusion Criteria:\n\n1. Partial response achieved under standard-of-care approved first-line immunotherapy\n2. CTCAE Grade ≥3 or more toxicity under standard-of-care approved first-line immunotherapy, or persistent toxicity Grade \\>1\n3. Liver involvement \\> 50%\n4. Presence of major macro vascular invasion (except Vp1\u002FVp2)\n5. Pregnant woman, or breastfeeding or women of child-bearing potential with no adequate contraception (see §4.3.1)\n6. Under curatorship, guardianship, safeguard of justice or deprived of liberty\n7. History of serious autoimmune disease\n8. Interstitial lung disease\n9. HBV chronic infection with HBV DNA \\> 100 IU\u002FmL or without antiviral therapy; HBV patients with cirrhosis should be treated\n10. HIV infection\n11. Immunosuppression, including subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg\u002Fday prednisone equivalent)\n12. Transplanted liver, or patient with intent for transplantation\n13. Has difficulties in swallowing.\n14. Has undergone major surgery or significant trauma ≤4 weeks prior to Screening. Note: Participants who had surgery \\>4 weeks prior to Screening must have recovered adequately from any toxicity and\u002For complications from the surgery or trauma prior to starting study intervention.\n15. Is currently participating in or has participated in a study with an investigational compound or device within 3 months prior to the first dose of study intervention.\n\n    Note: Participants who have entered the follow-up phase of an investigational study may participate so long as it has been at least 3 months since the last dose of the previous investigational agent.\n16. Has a systemic infection or other serious infection requiring systemic treatment within 30 days prior to Screening.\n17. Has a history of hypersensitivity to EXL01 and\u002For any excipients, which are listed in the IB, and\u002For to soybean or soy-containing products\n18. Has a history of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies\n19. Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea, or other inflammatory disease requiring anti-inflammatory medications\n20. Current probiotics administration, or planned probiotics administration during treatment course.\n21. Specific contra-indication to the continuation of the standard-of-care approved first-line immunotherapy :\n\n21.1: for atezolizumab-bevacizumab:\n\n* Thromboembolic events in the 3 months prior to inclusion\n* Prior bleeding event due to untreated or incompletely treated esophageal and \u002F or gastric varices within 6 months' prior inclusion\n* Has a history of hypersensitivity to the atezolizumab or to any of the excipients listed in section 6.1 of the SmPC of atezolizumab\n* Has a history of hypersensitivity to bevacizumab or to any of the excipients listed in section 6.1 of the SmPC of bevacizumab\n* Uncontrolled hypertension\n* Clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure\n* Proteinuria 21.2: for durvalumab:\n* Has a history of hypersensitivity to the durvalumab or to any of the excipients listed in section 6.1 of the SmPC of durvalumab.",{"count":180,"type":20},34,[107],"Hepatocellular carcinoma (HCC) is the most common liver primary cancer with a high rate of mortality. Since the results of IMbrave150, immunotherapy have emerged as a standard of care for HCC patients advanced and\u002For unresectable in first line of treatment. The objective response rate was about 30%, but half of patients would present only stable disease and about 20% progressive disease.\n\nFaecalibacterium prausnitzii is one of the most abundant bacterial in human gut microbiota, around 5% of total bacteria in feces.\n\nFor patients with metastatic melanoma, treated with ipilimumab, an antibody targeting CTLA-4 (Cytotoxic T-lymphocyte-associated antigen 4), patients with a baseline gut microbiota enriched with Faecalibacterium had a significantly better clinical outcomes. In patients with metastatic melanoma, the level of Faecalibacterium prausnitzi at baseline was predictive of response to anti-PD-1 (programmed death-1) or anti-CTLA-4 therapy. EXL01 is a pharmacological preparation of Faecalibacterium prausnitzii strains. Preclinical murine study suggests that the administration of EXL01 could reverse the resistance to ICI induced by antibiotics (unpublished data).\n\nWe thus plan to test the concept of microbiota modification in patients treated with standard-of-care approved first-line immunotherapy for advanced HCC. We would include patients refractory to first-line treatment, and test the addition of EXL01 to standard-of-care approved first-line immunotherapy in order to reverse resistance.",[184],"Hepatocellular Carcinoma",[113,186,187,188,189],"microbiome","resistance","dysbiosis","Faecalibacterium prausnitzii","2025-07-31",{"date":139,"type":34},{"date":193,"type":34},"2025-03-12",{"date":195,"type":20},"2026-12-12",{"name":40,"class":41},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":42},"100543650","identification-of-risk-factors-for-brain-recurrence-in-patients-with-her2-positive-localised-breast-cancer-100543650","NCT06358625","Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer","CRANIUM","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* be a female patient\n* Patients with histologically proven HER2-positive invasive breast cancer (IHC 3+ or 2+ with positive SISH),\n* Neoadjuvant chemotherapy and intra-tumour clips indicated at the multidisciplinary consultation meeting (RCP).\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women\n* Have had a haematoma requiring level II analgesics at the time of the diagnostic biopsy.\n* Known coagulation disorders\n* Individual deprived of liberty or placed under the authority of a tutor, or a currator\n* Not be affiliated to a social security regimen",{"count":205,"type":20},120,"HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.\n\nAt the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).\n\nThe presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.\n\nInternational guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.\n\nTo date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.\n\nNew tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment.",[208],"HER2-positive Breast Cancer",[210,211,58],"Metastases","Central Nervous System",{"date":213,"type":34},"2025-08-01",{"date":215,"type":34},"2024-06-06",{"date":217,"type":20},"2031-06-06",{"name":40,"class":41},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100349513","erectile-dysfunction-in-good-prognosis-prostate-cancer--comparison-between-brachytherapy-and-stereotactic-body-radiotherapy-100349513","NCT03830788","Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy","Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy","TEMPOS","Main inclusion criteria\n\n* Biopsy proven prostate adenocarcinoma,\n* Low risk prostate cancer according to d'Amico (T1-T2a and PSA \\\u003C10 ng\u002Fml, and Gleason score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor with Gleason score 7 (4 + 3),\n* Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting,\n\nMain exclusion criteria\n\n* Androgen deprivation therapy,\n* Contraindication for prostate Iodine 125 brachytherapy (Prostate volume \\> 50 cc, impossibility if general anesthesia).\n* Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)\n* Participation to another research which could have an impact on the study treatment and the outcomes",{"count":228,"type":20},240,[23],"The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to \"standard\" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.\n\nEight patients\u002Fyear\u002Fcenter are expected to be recruited in 2 years in about twenty participating centers.\n\nIn total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.",[232],"Prostate Cancer",[234,235,236],"SBRT","brachytherapy","localized low-risk and intermediate risk prostate cancer",{"date":213,"type":34},{"date":239,"type":34},"2019-10-04",{"date":241,"type":20},"2031-04-04",{"name":40,"class":41},20,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":42},"100564276","optical-surface-guidance-for-external-radiotherapy-of-head-and-neck-cancer-100564276","NCT06627075","Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer","Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer","SUGAR","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer\n* Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35\n* Patients who have dated and signed an informed consent form\n\nExclusion Criteria:\n\n* Patients with uncontrollable movements\n* Patients under psychiatric care\n* Patients who do not understand or read French\n* Patients participating in an interventional study testing another medical intervention\n* Patients under guardianship, curatorship, safeguard of justice or deprived of liberty\n* Pregnant or breast-feeding women\n* Patients without social security coverage",{"count":253,"type":20},40,[23],"The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.",[257],"Otorhinolaryngeal Cancer",[259,260],"Radiotherapy","Optical surface guidance","2025-02-11",{"date":263,"type":34},"2025-02-13",{"date":265,"type":34},"2024-12-12",{"date":267,"type":20},"2027-01-12",{"name":40,"class":41},""]