[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Federation Francophone de Cancerologie Digestive\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":358},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,73,101,127,149,172,194,222,251,287,313,334],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100642918","phase-2-personalize-signature-driven-neoadjuvant-chemotherapy-trial-for-patients-with-resectable-borderline-pancreatic-ductal-adenocarcinoma-100642918",false,"NCT07616362","Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.","a Multicenter Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.","NEOPREDICT","Inclusion Criteria:\n\n* Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan (including non-contrast acquisition, pancreatic phase and portal venous phase), with stage confirmed by a local pancreatic expert review board including at least medical oncologist\u002Fonco-gastroenterologist, pancreatic surgeon and pancreatic expert radiologist. No central review is required,\n* Measurable pancreatic lesion according to RECIST 1.1 (CT scan or MRI \\\u003C 28 days),\n* WHO PS 1 or 0,\n* Histologically proven pancreas ductal adenocarcinoma,\n* Available FFPE from pancreatic tumor sample with \\> 10% of tumor cells (assessed by a local expert pancreatic pathologist),\n* No prior chemotherapy or radiation for pancreatic cancer (except one cycle of mFOLFIRINOX during waiting time for GEM + signature) or resection of pancreatic cancer,\n* Age ≥18 years old and ≤ 80 years old if geriatric standardized evaluation validates the study chemotherapy regimen administration for patients between 75-80,\n* Written informed consent obtained from patient before any protocol related intervention,\n* Acceptation and ability to conform to the protocol requirement during all the duration of the investigation including treatment, scheduled visits, clinical and biological examinations and follow up,\n* Adequate organ function, as defined by the following:\n* AST and ALT \\\u003C 3.5 x upper limit of normal (ULN),\n* Total serum bilirubin \\\u003C 3 x ULN, (for patients with total serum bilirubin between 1.5 and 3 x ULN, the dose of irinotecan will be adjusted in accordance with the SmPC).\n* Serum albumin \\>30 g\u002FL,\n* Hemoglobin \\>9.0 g\u002Fdl,\n* Absolute neutrophil count (ANC) \\>1.5 G\u002FL,\n* Platelets \\>100 G\u002FL,\n* Creatinine clearance \\> 50 mL\u002Fmin (according to CKD-EPI),\n* Normal Kalemia, calcemia, magnesemia\n* Women of childbearing potential must agree to use contraception during treatment and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments.\n* Patient affiliated to French social security\n\nExclusion Criteria:\n\n* Strictly resectable or locally advanced PDAC according to NCCN criteria,\n* Distant metastases (including inter aortic lymph nodes),\n* Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5FU, GEMCITABINE or NAB-PACLITAXEL,\n* Partial or complete DPD deficiency (uracilemia ≥ 16 ng\u002FmL),\n* Any progressive pathology not stabilized over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure.\n* Other concomitant cancer or a history of cancer during the previous 3 years, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated,\n* Other interventional clinical trial except for non-interventional trial (ie not modifying 1-year EFS),\n* QT\u002FQTc (Fredericia Correction) interval \\> 450 msec for men and \\> 460 msec for women,\n* Pregnant or breastfeeding woman,\n* Known Gilbert's syndrome or known homozygosity for UGAT1A1\\*28 polymorphism,\n* Treatment with millepertuis,\n* Uncompensated asthma,\n* Potentially severe infection \\\u003C 7 days,\n* Inflammatory bowel disease and\u002For intestinal obstruction,\n* Known severe allergy to contrast dye (for CT or MRI) without possible substitution,\n* Hypersensitivity to the active substance or to one of the excipients of one of the study treatments,\n* Treatment with brivudine within 4 weeks prior to the administration of protocol treatment,\n* Concomitant treatment with a strong inhibitor (i.e. ketoconazole) or inducer (i.e. rifampicin, carbamazepine, phenobarbital, phenytoin, apalutamide) of cytochrome P450 3A4 or 2C8 (CYP3A4 or CYP2C8),\n* Patient who has received a live attenuated vaccine (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus) in the 6 weeks prior to randomization,\n* Patient with sensitive peripheral neuropathy with functional discomfort,\n* Impossibility of undergoing medical monitoring during the trial for geographical, social, or psychological reasons,\n* Patient who is under judicial protection (patient who is legally institutionalized or under guardianship or curatorship) or not able to give consent. (as refered at art. art. L. 1121-6, art. L. 1121-8, art. L. 1121-8-1 du Code de la Santé Publique)","ALL","18 Years","80 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Pancreatic ductal adenocarcinoma (PDAC) exhibits significant heterogeneity, making the optimal choice of chemotherapy challenging. While targeted therapies benefit from companion biomarkers, few tools exist to guide the selection of cytotoxic chemotherapy. Transcriptomic signatures now allow for the prediction of sensitivity to cytotoxic agents. Several molecular classifications (such as basal-like, classical, etc.) have been established and correlated with prognosis, but they are rarely used in clinical practice. The PaCaOmics program has developed robust predictive signatures, grouped under the name Pancreas-View Signature, capable of analyzing FFPE samples using minimal material.\n\nLocally advanced or borderline resectable pancreatic cancer (BR-PDAC) accounts for approximately 20% of cases. Neoadjuvant chemotherapy (NAC) has become the standard of care, improving R0 resection rates and overall survival. The two main chemotherapy regimens used are mFOLFIRINOX and GEM\u002FNAB-paclitaxel, which show comparable efficacy and toxicity profiles. However, no clear consensus exists on the superiority of one over the other. Therefore, predictive biomarkers are crucial to help select the most appropriate neoadjuvant regimen, avoid unnecessary toxicities, and maximize the chances of curative surgery. The NEOPREDICT trial aims to evaluate the efficacy of treating patients with borderline resectable PDAC identified with a GEM+ sensitivity transcriptomic signature with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NAC.",[28],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","NOT_YET_RECRUITING","2026-06-09",{"date":32,"type":33},"2026-06-11","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2031-04",{"name":39,"class":40},"Federation Francophone de Cancerologie Digestive","OTHER",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100602541","prospective-national-cohort-evaluating-prognostic-factors-for-efficacy-of-fruquintinib-treatment-in-patients-with-metastatic-colorectal-cancer-100602541","NCT07124858","Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer","PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer","COFRUQ","Inclusion Criteria:\n\n* Patients aged 18 and over.\n* Histologically confirmed colorectal adenocarcinoma with locally advanced disease and\u002For unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate\u002Fearly access and ii) marketing authorisation and reimbursement in France.\n* Obtain informed consent from the patient for the clinical-biological cohort.\n* Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).\n\nExclusion Criteria:\n\n* Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).\n* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).\n* Pregnant or breast-feeding women.\n* Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).",{"count":51,"type":22},300,[53],"NA","The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.",[56,57,58],"Metastatic Colorectal Cancer (CRC)","Antineoplastic Agents, Immunological","VEGFR-TKI",[60,61,62],"Metastatic colorectal cancer","Fruquintinib","cohort","RECRUITING","2026-05-22",{"date":66,"type":33},"2026-05-26",{"date":68,"type":33},"2026-03-10",{"date":70,"type":22},"2031-12-31",{"name":39,"class":40},83,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100613776","phase-3-trifluridinetipiracil--fruquintinib-versus-trifluridinetipiracil-alone-for-metastatic-oeso-gastric-adenocarcinoma-100613776","NCT07270991","Trifluridine\u002FTipiracil + Fruquintinib Versus Trifluridine\u002FTipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma","Randomized Phase III Trial to Compare Trifluridine\u002FTipiracil + Fruquintinib Versus Trifluridine\u002FTipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma","FRUQUITAS","Inclusion Criteria:\n\n1. Age ≥ 18 years (patients enrolled gender independently).\n2. Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus.\n3. Prior treatment by two or three lines of treatment for metastatic setting (patients who received adjuvant therapy and developed metastatic disease within 6 months of completing treatment should be considered as having failed first-line therapy for metastatic disease).\n4. Prior treatment (progression or intolerance) with platinum salts (oxaliplatin or cisplatin), fluoropyrimidine and irinotecan and\u002For taxane (+\u002F- anti-HER2 agents +\u002F- immune checkpoint inhibitors +\u002F- ramucirumab +\u002F- anti-claudin 18.2).\n5. Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n6. World Health Organisation (WHO) performance status 0-1.\n7. Adequate organ function: ANC ≥ 1.5 x 109\u002FL, hemoglobin ≥ 9 g\u002FdL, platelets ≥ 100 G\u002FL, AST\u002FALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), total bilirubin ≤ 1.5 x ULN, creatinine clearance \\> 30 mL\u002Fmin (CKD EPI).\n8. Adequate coagulation tests (INR and activated partial thromboplastin time (APTT) ≤1.5 × ULN) unless the patient is receiving anticoagulant therapy.\n9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\n10. Man and woman of childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (use contraceptive methods that result in a failure rate of \\\u003C1% per year) during the study and for 6 months after the last treatment intake.\n11. Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.\n12. Available tumor block (surgical specimens of primary tumor and if not available tumor biopsies).\n13. Patient willing to participate to biological studies.\n\nExclusion Criteria:\n\n1. Concurrent enrolment in another clinical study - unless it is an observational study or during the follow-up for survival status update only of an interventional study.\n2. Administration of the last dose of anticancer therapy and palliative radiotherapy ≤ 2 weeks prior to the first dose of study drug.\n3. Current or prior bowel obstruction within 28 days before the first dose of study drugs.\n4. Any unresolved clinical significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (except neuropathy).\n5. More than 3 prior lines of treatment.\n6. Major surgical procedure (e.g. exploratory laparoscopy is not considered as a major surgical procedure) within 2 weeks prior to the first dose of treatment.\n7. History of leptomeningeal carcinomatosis or symptomatic or untreated brain metastase(s). Patients whose brain metastase(s) have been treated may participate if any neurologic symptoms that developed as a result of the brain metastases are resolved or stable.\n8. Severe cardiac disorders (including but not limited to acute myocardial infarction, stroke, unstable angina, NYHA class III\u002FIV heart failure, or LVEF\\\u003C50%) within 6 months.\n9. Severe liver dysfunction (cirrhosis Child Pugh B or C).\n10. Gastric or duodenal active ulcer.\n11. Thromboembolic events (including deep vein thrombosis and pulmonary embolism) in the past 6 months\n12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled hypertension (defined as systolic blood pressure ≥140 mm Hg and\u002For diastolic blood pressure ≥90 mm Hg despite optimal medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea,\n13. psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n14. Patients with urine protein test 2+ or more and 24 hours urine protein≥1.0g\u002F24h.\n15. Known positive test for HIV, active hepatitis B or hepatitis C, active tuberculosis.\n16. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (excipients with known effects and potential risk of allergies : tartrazine (E102) ,sunset yellow FCF (E110), Lactose monohydrate).\n17. Prior treatment with trifluridine\u002Ftipiracil and\u002For fruquintinib and\u002For regorafenib and\u002For any anti-VEGFR tyrosine kinase inhibitor.\n18. Active infection requiring intravenous antibiotics at the time of Day 1 of Cycle 1.\n19. Other malignancy within 3 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer or other localized tumor with complete resection.\n20. Treatment with powerful CYP 450 inducers (no contraindication for inhibitors).\n21. Pregnant or breastfeeding female patient.\n22. Congenital galactosemia, total lactase deficiency (lactose intolerance) or glucose-galactose malabsorption syndrome.\n23. Patients with clinically significant bleeding within the past 2 months.",{"count":82,"type":22},324,[84],"PHASE3","Advanced cancer of the stomach and the gastro-esophageal junction (G\u002FGEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life.\n\nFirst treatments usually combine two chemotherapies, but recent years have brought real progress. Immunotherapy - drugs that \"unlock\" the immune system - has shown clear benefits. For patients whose tumors have certain markers (like PD-L1), combining drugs such as nivolumab or pembrolizumab with chemotherapy can help patients live longer. Another breakthrough is zolbetuximab, a targeted therapy that attacks a protein (Claudin 18.2) found on many gastric cancers, also improving survival.\n\nWhen cancer grows despite these therapies, second-line treatments are used. The most common is chemotherapy with paclitaxel + ramucirumab, which blocks the tumor's blood supply. These drugs extend survival, but usually only by a few months.\n\nFor patients who need a third option, the oral drug trifluridine\u002Ftipiracil (TAS-102) can provide extra time, though benefits remain limited. That's why researchers are now exploring combinations. Since stomach tumors rely on forming new blood vessels, combining trifluridine\u002Ftipiracil with anti-angiogenic drugs - medicines that cut off the tumor's blood supply - looks promising.\n\nOne of the most exciting of these drugs is fruquintinib, already proven effective in colorectal cancer. A new international trial, FRUQUITAS (ENGIC 06\u002FPRODIGE 114), is now testing whether adding fruquintinib to trifluridine\u002Ftipiracil can improve survival for patients with advanced stomach or gastro-esophageal cancer.",[87],"Metastatic Oesogastric Adenocarcinoma",[89,61,90,91],"Cancer","oeso-gastric","third line","2026-02-03",{"date":94,"type":33},"2026-02-05",{"date":96,"type":33},"2025-12-15",{"date":98,"type":22},"2030-11-30",{"name":39,"class":40},64,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100543283","prospective-national-cohort-evaluating-predictive-biomarkers-of-resistance-to-immunotherapy-in-patients-with-msidmmr-metastatic-colorectal-cancer-coresim-100543283","NCT06353854","Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI\u002FdMMR Metastatic Colorectal Cancer (CORESIM)","National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer","CORESIM","Inclusion Criteria:\n\n* Patients over 18 years old\n* Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab\n* Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and\u002For PMS2) and\u002For by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center)\n\nExclusion Criteria:\n\n* Patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team.\n* Previous treatment with anti-PD1 or anti-PDL1.\n* Previous treatment with chemotherapy +\u002F- targeted therapy for MSI\u002FdMMR metastatic colorectal cancer.\n* Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons).\n* Pregnant women\n* persons under court protection or under protective supervision (guardianship or curatorship)\n* Opposition to participation in the study.",{"count":110,"type":22},600,"OBSERVATIONAL","The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +\u002F- targeted therapy in first-line treatment of dMMR\u002FMSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR\u002FMSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.",[114,115],"Colorectal Cancer Metastatic","Microsatellite Instability-High Colorectal Cancer",[117],"immunotherapy resistance","2025-10-01",{"date":120,"type":33},"2025-10-06",{"date":122,"type":33},"2024-02-12",{"date":124,"type":22},"2030-02-12",{"name":39,"class":40},20,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100604506","phase-2-second-line-doublet-chemotherapy-folfox-or-folfiri-plus-fruquintinib-versus-doublet-chemotherapy-folfox-or-folfiri-plus-bevacizumab-in-metastatic-colorectal-cancer-100604506","NCT07150403","Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","A Phase II, Open-label, Non-comparative, Randomized Study of Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* \\- Age ≥ 18 years and ≤ 80 years; provided the score of the G8 geriatric questionnaire is \\>14 for patients 75 years or older\n* Patients with a histologically confirmed diagnosis of metastatic colorectal cancer (mCRC), with a documented disease progression (as per RECIST v1.1, assessed by the investigator and confirmed through CT or MRI).\n* Patients must have previously received first-line therapy with Bevacizumab or an EGFRi, in combination with either FOLFOX or FOLFIRI, for non-resectable mCRC. Patients who progressed during the adjuvant chemotherapy (FOLFOX) or within the 6 months following its completion are eligible for inclusion\n* Patients must have an unresectable tumor at the time of enrollment.\n* Patients must have at least one measurable\u002Fevaluable metastatic lesion according to RECIST v1.1 criteria; images have to be available for collection\n* Metastases not amenable to surgery and\u002For thermo-ablation and\u002For stereotaxic radiotherapy\n* WHO performance status 0 or 1\n* Available parameters to compute the SPOD score: WHO PS, hemoglobin, platelet count, WBC\u002Fabsolute neutrophil count ratio, lactate dehydrogenase (LDH), alkaline phosphatase, and the number of metastatic sites.\n* Adequate liver functions: Total Bilirubinemia \\\u003C 2,5 ULN, AST and ALT ≤ 5 ULN\n* Adequate hematological (Hemoglobin ≥10g\u002FdL, platelets ≥100G\u002FL, neutrophils ≥1.5G\u002FL) and renal (creatinine clearance ≥ 50 mL\u002Fmin according to CKD-EPI) functions\n* Proteinuria \\\u003C 2+ (dipstick urinalysis) (if 2+ or more, proteinuria must be ≤1g\u002F24hour)\n* Life expectancy ≥ 3 months\n* Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relations with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments\n* Ability of the patient to understand, sign and date the information note and informed consent form before any study specific procedures\n* Patient affiliated to a social security scheme\n* Available tumor sample and pathology report for collection\n\nExclusion Criteria:\n\n* \\- Patients who have received more than one prior systemic therapy\n* FOLFIRINOX Regimen +\u002F- targeted therapy in the first line setting\n* Unknown RAS status\n* BRAF V600E mutated tumor\n* MSI\u002FdMMR tumor\n* Known brain metastasis\n* Known peritoneal carcinomatosis if there are signs of clinical occlusion or sub-occlusion\n* History of gastric ulceration, or myocardial infarction, or severe coronaropathy or severe cardiac dysfunction, within the past 6 months prior to treatment start\n* Patients with dihydropyrimidine dehydrogenase deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Hypersensitivity to one of the study drugs or one of its excipients\n* Inability to swallow capsules\n* Live attenuated vaccines 30 days prior to treatment start\n* Untreated bone fracture\n* Significant haemorrhagic diathesis or coagulopathy (in the absence of anti-coagulant treatment)\n* Major surgery, open biopsy or major traumatic lesion in the prior 30 days or the need for major surgery during the trial\n* Pregnant or breastfeeding woman or patients with no adequate contraception\n* Known Uridine Diphosphate Glucuronyltransferase (UGT1A1) deficiency or known Gilbert disease\n* Strong inducers of CYP3A4 (treatment with St John's Wort (Hypericum perforatum), fampicin, phenobarbital, primidone, phenytoin and carbamazepine)\n\n  \\-- Strong inhibitors of CYP3A4, continuous use of azole antifungals (posaconazole, voriconazole, itraconazole, isavuconazole), ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to half a fresh grapefruit\u002Fday)\n* Concomitant or recent treatment with sorivudine or its analogs (including brivudine) within 4 weeks prior to the administration of protocol treatment (related to Fluorouracil)\n* Concomitant treatment with phenytoin or its analogs\n* QT\u002FQTc interval \\> 450 ms for men and \\> 470 ms for women\n* Uncontrolled hypertension (defined as systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg) or history of hypertensive crisis (TA systolic\\> 20 mmHg) or hypertensive encephalopathy\n* History of veinous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within the past month prior to study enrollment\n* History of stroke and\u002For transient ischemic attack (TIA) within the past 12 months\n* Residual Oxaliplatin neuropathy (grade ≥ 2) counter indicates FOLFOX administration\n* Persistence of clinically significant symptoms after a thromboembolic event despite anticoagulant treatment\n* Arterial thromboembolism (myocardial infarction, stroke, transient ischemic attack) occurring under antiangiogenic therapy\n* Other active cancers or history of cancer treated within the last 5 years except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured\n* Persons deprived of liberty or under guardianship or unable of giving consent\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons",{"count":135,"type":22},74,[25],"The standard second-line treatment for metastatic colorectal cancer (mCRC) involves chemotherapy (FOLFOX or FOLFIRI) combined with an antiangiogenic agent, such as bevacizumab or aflibercept. Maintaining VEGF inhibition between first and second-line treatments has shown modest clinical benefits, with exploratory analyses suggesting that bevacizumab is more effective in smaller tumors. The ULYSSE trial aims to evaluate the efficacy and safety of Fruquintinib, a potent antiangiogenic agent, combined with a doublet chemotherapy (FOLFOX or FOLFIRI) in second-line treatment for BRAF wild-type, MSS mCRC patients who have failed prior treatment.",[139],"Metastatic Colorectal Carcinoma (mCRC)","2025-09-01",{"date":142,"type":33},"2025-09-08",{"date":144,"type":22},"2025-12-31",{"date":146,"type":22},"2028-10-31",{"name":39,"class":40},45,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100532067","phase-3-phase-iii-study-evaluating-induction-chemotherapy-followed-by-chemoradiotherapy-compared-to-standard-chemoradiotherapy-for-locally-advanced-scca-100532067","NCT06207981","Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA","PRODIGE 85- KANALRAD : Prospective Randomized Phase III Study Evaluating Induction Chemotherapy (Modified DCF 4 Cycles) Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced Anal Squamous Cell Carcinoma (T3-4 or N1a, b or c)","KANALRAD","Inclusion Criteria:\n\n1. Anal Squamous cell carcinoma histologically proven\n2. Locally advanced tumors without metastases\n\n   * Stage T3 or T4\n   * Stage N1 (a, b or c) - any T (T1 to T4)\n3. Age ≥18 and ≤ 75 or \\> 75 in case of score G8 \\> 14 or favourable oncogeriatric assessment\n4. Measurable tumor on MRI\n5. Able to receive chemotherapy and radiotherapy\n6. No major comorbidity that may preclude the delivery of treatment\n7. Adequate hematologic function: absolute neutrophil count ≥ 1500\u002Fmm3, platelet count ≥ 100 000\u002Fmm3, Hb ≥ 9g\u002Fdl\n8. Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml\u002Fmin\n9. Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN\n10. WHO performance status \\\u003C 2\n11. Signature of informed consent\n12. A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a \"urine pregnancy test\", it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)\n13. Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)\n14. Patient to be covered by a regimen of French Social Security system.\n\nExclusion Criteria:\n\n1. Presence of metastases\n2. Stage T1N0 or T2N0\n3. History of pelvic radiotherapy\n4. Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng\u002FmL)\n5. Positive HIV serology with CD4 \\\u003C 400 \u002F mm3\n6. Presence of neuropathy \\> grade 2 according to NCIC-CTC 4.0\n7. Contraindication for chemotherapy and\u002For radiotherapy\n8. Concomitant treatment with CYP3A4 inhibitors or inducers\n9. Symptomatic cardiac or coronary insufficiency\n10. Progressive active infection or any unbalanced progressive severe condition in the last 6 months\n11. No contraindication to MRI imaging\n12. Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular\u002F spinocellular carcinoma or any other carcinoma in situ considered as cured\n13. breastfeeding woman.\n14. Persons deprived of liberty or under guardianship or incapable of giving consent\n15. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.\n16. Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine",{"count":158,"type":22},310,[84],"Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines radiotherapy and chemotherapy with 5FU and mitomycin-C. Chemoradiotherapy (CRT) achieves a good outcome for early stage tumors (T1-T2 tumors without nodal involvement), but more advanced tumors (T3-T4 or N1) are associated with a dismal prognosis. About 35 % of such patients relapse within two years after the end of treatment Recently, for metastatic or recurrent tumors after chemoradiotherapy, a chemotherapy combining docetaxel, cisplatin and 5FU (modified DCF protocol) has given very good results with a median overall survival of 39.2 months in 2 French trials (Epitopes HPV01 and 02). Our idea is to propose a new strategy , associating this chemotherapy (mDCF) followed by chemoradiotherapy to improve efficacy of the treatment for patients with locally advanced anal cancers. To this end, The principal investigator propose a national, multicenter, randomized phase 3 clinical trial to compare induction chemotherapy with mDCF followed by chemoradiotherapy versus standard chemoradiotherapy for locally advanced anal canal cancer.\n\nthe efficacy of the treatment will be evaluated by comparing disease-related event-free survival at 2 years according to the type of treatment. Other endpoints will also be evaluated such as overall survival and colostomy-free survival, treatment tolerability, response rate and quality of life.\n\nThis trial will be offered to patients over 18 years of age with locally advanced anal cancer without metastasis (T3-4 or N1). It is open to patients over 75 years of age subject to a favorable evaluation by an oncogeriatrician. It is also open to immunocompromised patients (HIV+) if their immunity is well controlled under antiretroviral treatment.The standard chemoradiotherapy treatment consists of 33 sessions of radiation, one session per day from Monday to Friday for 6.5 weeks. It is combined with chemotherapy that includes mitomycin during the first and fifth weeks of radiation therapy, as well as capecitabine that are taken on the days of radiation therapy.In the experimental arm, this chemoradiotherapy treatment is preceded by 4 sessions of mDCF chemotherapy performed every 2 weeks.After treatment, patients are followed up at 8 weeks, then every 4 months for 2 years, and every 6 months for the last year with clinical examination and imaging (CT and MRI).",[162],"Anal Cancer","2025-08-29",{"date":165,"type":33},"2025-09-02",{"date":167,"type":33},"2024-02-26",{"date":169,"type":22},"2030-02-01",{"name":39,"class":40},114,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100493563","phase-2-encorafenib-plus-cetuximab-in-a-neoadjuvant-setting-in-patients-with-braf-mutation-localised-colon-or-upper-rectum-cancer-100493563","NCT05706779","Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer","Combination of Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With Braf v600e-mutates Localised Colon or Upper Rectum Cancer (Neoraf Study)","NEORAF","Inclusion Criteria:\n\n* Informed consent signed and dated by the patient and the investigator\n* Age ≥18 years at time of informed consent\n* Adenocarcinoma of the colon or of the upper rectum (supra-peritoneal) considered operable and histologically confirmed, localised, mutated BRAF V600E determined in a biopsy specimen and resectable after CT-scan assessment.\n\nRemark: Centralised analysis of BRAF status will be performed in order to confirm the existence of the mutation concomitantly with the 1st cycle of therapy\n\n* Tumour stage rT4 or rT3 with ≥ 5 mm extra-mural extension in a CT-scan.\n\n  * rT3 with high risk: Tumour spread from the peripheral serosa and extension to the adjacent peritoneal fat of more than 5 mm in its longest diameter (both axial and coronal planes)\n  * rT4: Extension to an adjacent organ\n* Patient able to provide a sufficient quantity of representative tumour sample (slides or extracted tumor DNA) for centralised analysis of RAS and BRAF mutational status.\n* WHO performance status 0 or 1\n* Haematological function considered satisfactory:\n\n  * Polymorphonuclear neutrophils (PMN) ≥ 1,500\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hb ≥ 9g\u002FdL\n* Creatinine clearance \\> 50 mL\u002Fmin (according to MDRD formula).\n* Serum levels of magnesium within normal limits of the centre.\n* Total serum bilirubin ≤ 25 μmol\u002FL, ALT and\u002For AST ≤ 2.5 x ULN.\n* Cardiac function considered satisfactory:\n\n  o Corrected mean QT interval for heart rate according to the Fridericia formula (QTcF) ≤ 480 ms.\n* Patient able to take medicinal products by mouth (OD).\n* Female Patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male and female patients of childbearing potential for 2 months after the end of the investigational treatments\n* A negative pregnancy test for inclusion for all female patients of child-bearing FFCD 2006 - NEORAF Version 1.0- 21\u002FOctober2022 Page 7 of 69 potential.\n* Patient covered by a plan of the French Social Security system\n\nExclusion Criteria:\n\n* Existence of distant metastases or adjacent nodules of peritoneal carcinosis (M1).\n* Existence of a dual-tumour location.\n* known RAS mutation\n* Peritonitis (secondary to perforation of the tumour) or symptomatic colonic occlusion or a temporary colostomy to prevent a sub-occlusion.\n* Patient in whom an indication for radiotherapy exists based on the multidisciplinary meeting\u002Fboard pre-operatively.\n* Previous treatment with a BRAF inhibitor, cetuximab or other anti-EGFR treatment.\n* History of acute or chronic pancreatitis within the 6 months prior to start of the study treatment.\n* A history of chronic inflammatory bowel disease requiring treatment (with immuno-modulators or immuno-suppressants) ≤ 12 months before start of study treatment.\n* Patient with decreased cardiovascular function or clinically significant cardiovascular disease:\n\n  1. History of myocardial infarction, acute coronary syndrome (including unstable angina, coronary artery bypass grafting, coronary angioplasty or stent placement) ≤ 6 months prior to start of the study treatment.\n  2. Symptomatic congestive heart failure (CHF) (grade 2 or higher), history or current evidence of cardiac arrhythmia and\u002For a clinically significant conduction disorder ≤ 6 months prior to start of the study treatment, except atrial fibrillation with controlled heart rate and paroxysmal supra-ventricular tachycardia.\n* Child-Pugh class B or C cirrhosis.\n* Deterioration of gastro-intestinal function or a disease which may significantly impair the absorption of encorafenib, e.g.: ulcer disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, small bowel resection\n* A previous or concomitant malignant tumour within 5 years prior to the study. Except for basal cell or squamous skin cancer, superficial cancer of the bladder, intra-epithelial carcinoma of the prostate, carcinoma in situ of the uterine cervix or any other malignant tumour which has been treated adequately and which has not recurred during the three years prior to entry in the study.\n* A concomitant neuro-muscular disease associated with high levels of creatinine kinase (CK).\n\nRemark: inflammatory muscular disease, muscular dystrophy, amyotrophic lateral sclerosis (ALS), spinal muscular atrophy.\n\n* History of infection with human immunodeficiency virus (HIV).\n* Active infection with hepatitis B or hepatitis C.\n* Known existence of Gilbert syndrome\n* Use of medicinal plants\u002Fdietary supplements or other medicinal products or foods that are potent inducing agents or inhibitors of cytochrome P450 (CYP) 3A4\u002F5 ≤ 1 week before start of the study treatment.\n* Known severe hypersensitivity reactions to monoclonal antibodies or BRAF-inhibitors (grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n* Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, according to the longest period, prior to the first dose of the study treatment.\n* Persons who are deprived of their freedom or who are under guardianship",{"count":181,"type":22},30,[25],"This is a pilot trial which aims to assess the concept of anti-BRAF neoadjuvant treatment (encorafenib) in combination with cetuximab in patients with colon cancer or rT3\u002FT4 supra-peritoneal upper rectal cancer based on a pre-operative CT-scan. About 10% of patients will have a mutated BRAF V600E tumour and the objective is to include 30 patients with this mutation.\n\nIf the tumour is not confirmed as a carrier of the BRAF V600E mutation or has an RAS mutation according to centralised assessment, treatment will be discontinued in this patient and cancer surgery will be organised as soon as possible. The patient will be excluded from the statistical analysis and will be replaced by a new patient in order to obtain 30 patients with confirmed BRAF V600E mutation and RAS wild type . It should be noted that less than a 3% discrepancy between the numbers of local laboratory results and central analysis results, has been reported in over 600 BRAF V600E mutated colon cancers in the BEACON CRC study. Based on these figures, there should be 0 or 1 patient with discrepant results in the study presented here.\n\nFurthermore, in the hypothetical case of a patient who is an early permanent discontinuation of the study prior to surgery, this patient will be replaced in order to obtain a total of 30 patients who underwent surgery after neoadjuvant treatment.",[185,186],"Colorectal Cancer","BRAF V600E Mutation Positive",{"date":165,"type":33},{"date":189,"type":33},"2023-02-13",{"date":191,"type":22},"2029-05-31",{"name":39,"class":40},1,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":209,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100602543","phase-2-5-fluorouracil-plus-panitumumab-anti-egfr-and-sotorasib-kras-g12c-inhibitor-in-first-line-treatment-of-patients-non-eligible-for-a-doublettriplet-chemotherapy-with-advanced-unresectab-100602543","NCT07124884","5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO: Single-arm Phase II Study Evaluating 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.\n* Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test\n* Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).\n* Patient with one these criteria:\n\nPatient with WHO PS=2 Patient between 70 and 75 years old with WHO PS 1 Patient ≥ 75 years old\n\n* Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).\n* No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed if there is more than 6 months between the end of adjuvant treatment and relapse.\n* Adequate organ function: Hemoglobin \\> 9 g\u002Fdl, Absolute neutrophil count \\> 1500 \u002Fmm3, Platelets \\> 80 000\u002Fmm3, Creatinine clearance rate ≥50 mL\u002Fmin as calculated using MDRD formula, ALT\u002FAST ≤5×ULN and total bilirubin ≤1.5×ULN.\n* Ability to understand and sign written informed consent to participate in the study.\n* Provides written informed consent for the study.\n* Life expectancy \\>6 months.\n* Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments.\n* Patient affiliated to a social security scheme for France, or equivalent for other countries.\n\nExclusion Criteria:\n\n\\- Patient with one of these criteria: Patient fit for doublet\u002Ftriplet regimen Patient with WHO PS 3 or 4 Patient \\\u003C 75 years old with WHO PS 0 Patient \\\u003C 70 years old with WHO PS 0 or 1\n\n* Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume \\\u003C50%) severe insufficiency.\n* Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).\n* Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).\n* Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng\u002FmL).\n* Immunotherapy within 3 months before the beginning of the treatment study.\n* Patient under treatment by strong CYP3A4 inducers.\n* Patients treated by brivudine within 4 weeks before the first dose of study treatment, or concomitant treatment with brivudine.\n* Patient with potentially serious infection.\n* Administration of live or live attenuated vaccine within 30 days prior to the first dose of study treatment start.\n* Poor nutritional state (albuminemia \\\u003C 25 g\u002FL or weight loss \\> 10% during the last month).\n* Hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption.\n* Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated.\n* Less than 4 weeks from major surgeries and not recovered adequately from the procedure and\u002For any complications from the surgery.\n* Patients with persistent toxicities related to prior treatment of grade greater than 1.Is c urrently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry.\n* Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments.\n* Patient with interstitial lung disease or pulmonary fibrosis.\n* Patients with history of interstitial pneumonitis or pulmonary fibrosis.\n* Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.\n* Pregnant or breastfeeding woman.\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.",{"count":51,"type":22},[25],"5-fluorouracil (5-FU) is a standard of care in frail\u002Felderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail\u002Felderly patients with unresectable KRAS G12C mutated CRC",[206,207,208],"Colorectal Carcinoma","KRAS G12C Mutation","Unresectable Colorectal Cancer",[210,211,212],"sotorasib","colorectal cancer","KRAS G12C","2025-08-14",{"date":215,"type":33},"2025-08-15",{"date":217,"type":22},"2025-08-31",{"date":219,"type":22},"2030-12-30",{"name":39,"class":40},80,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100602805","phase-2-perioperative-cisgem--rilvegostomig-in-high-risk-resectable-intra-hepatic-cholangiocarcinoma-100602805","NCT07128290","PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma","PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma Phase II Single Arm Study - Multicenter","PEHRICCA","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. WHO Performance Status 0-1\n3. Body weight \\> 30kg\n4. Histo\u002Fcytologically proven intrahepatic cholangiocarcinoma.\n5. Measurable disease as defined by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors).\n6. Naive to systemic treatment and loco regional treatment for biliary tract cancer\n7. At least one of the following high-risk criteria of post resection relapse:\n\n   * Tumor Size ≥ 50 mm and\u002For multiple nodules\n   * cN+\n   * Risk of narrow margin (\\\u003C 10 mm)\n   * Macrovascular invasion\n8. Adequate organ function, as defined by the following:\n\n   * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 2,5 x Upper Limit of Normal (ULN)\n   * Total serum bilirubin ≤ 1.5 ULN This will not apply to patients with confirmed Gilbert's syndrome\n   * Prothrombin ratio \\> 70 % and\u002For Factor V \\> 70 % in case of oral anticoagulation therapy\n   * Serum albumin ≥ 30 g\u002FL\n   * Haemoglobin ≥ 10 g\u002Fdl and no transfusion within 4 weeks before inclusion\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 G\u002FL\n   * Platelets ≥ 150 G\u002FL\n9. Creatinine clearance ≥ 45 ml\u002Fmin (calculated by CKD - EPI formula)\n10. Life expectancy ≥ 3 months\n11. Female postmenopausal for at least one year or surgically infertile for at least 6 weeks, or highly effective contraception for male and female patients of childbearing potential for the duration of study and for 7 months after the last dose of drug for female and 4 months for male.\n12. A negative pregnancy test for inclusion for all female patients of child-bearing potential.\n13. Patient covered by a plan of the French Social Security system.\n14. Written informed consent obtained from the patient prior to performing any protocol-related procedures\n15. Patient with available tumor tissue sample for the study or willing to have a biopsy\n\nExclusion Criteria:\n\n1. Existence of metastases or distant lymph node involvement considered as metastatic\n2. Locally advanced disease considered as definitively non resectable\n3. Cirrhosis with Child Pugh ≥ B7\n\n   1. Any history of liver decompensation: hepatic encephalopathy, presence of ascites\n   2. Presence of clinically significant portal hypertension (platelets counts \\\u003C 150G\u002FL and\u002For liver stiffness \\> 20kPa and\u002For presence of oesophageal and\u002For gastric varices)\n4. Mixed histology (hepatocholangiocarcinoma)\n5. Persistent toxicities (\\> grade 2 NCI-CTCAE version 5.0) caused by previous cancer therapy.\n6. Contraindication to immunotherapy: Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease\n7. Current or prior use of immunosuppressive medication within 14 days before the first dose of protocol treatment\n8. History of allogenic organ transplantation\n9. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients (cisplatin, gemcitabine and Rilvegostomig)\n10. Live vaccine administration within 30 days prior to the first dose of study treatment Note: Patients, if enrolled, should not receive live vaccine whilst receiving investigational product and up to 6 months after the last dose of investigational product.\n11. Uncontrolled infection with human immunodeficiency virus (HIV). Required conditions for inclusion are as follows: undetectable viral RNA, CD4+ count ≥350 cells\u002FμL no history of AIDS-defining opportunistic infection within the past 12 months, stable condition for at least 4 weeks on the same anti-HIV medications.\n12. Active and untreated infection with hepatitis B and\u002For hepatitis C Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen \\[HBc\\] antibody test) are eligible.\n13. Other active cancer or history of cancer within 2 years, except for carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured\n14. History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure (as defined by New York Heart Association class ≥ 3), history of myocardial infarction within the past 6 months. Participation in another clinical study with an investigational product during the last 4 weeks\n15. Pregnant or breastfeeding woman.\n16. Person deprived of liberty or under guardianship or incapable of giving consent\n17. Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.",{"count":231,"type":22},49,[25],"The goal of this trial is to determine whether the combination of CISGEM and Rilvegostomig during the perioperative period works to improve outcomes of patient undergoing surgery of high-risk of intrahepatic cholangiocarcinoma",[235],"Intrahepatic Cholangiocarcinoma (Icc)",[237,238,239,240,241],"Perioperative","Rilvegostomig","CISGEM","High-risk resectable","intrahepatic cholangiocarcinoma","2025-08-13",{"date":244,"type":33},"2025-08-17",{"date":246,"type":22},"2025-10-30",{"date":248,"type":22},"2029-04-30",{"name":39,"class":40},9,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":260,"conditions":261,"keywords":272,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100557710","a-french-multicenter-observational-retrospective-study-of-rare-primary-liver-cancers-100557710","NCT06541652","A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers","FFCD-2205","Inclusion Criteria:\n\n* 18 years of age or older,\n* with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma\n* diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort\n* for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.\n\nExclusion Criteria:\n\n* without social security\n* No access to tumor block",{"count":259,"type":22},150,"The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.",[262,263,264,265,266,267,268,269,270,271],"Hepatocholangiocarcinoma","Fibrolamellar Carcinoma","Hepatic Epithelioid Hemangioendothelioma","Hepatoblastoma","Hepatic Neuroendocrine Carcinoma","Hepatic Carcinosarcomas","Hepatic Cystadenoma","Hepatic Leiomyosarcomas","Hepatic Angiosarcomas","Cholangiocarcinoma",[273,274,275,276,277],"rare primary liver cancers","LIVER","HEPATIC","COHORT","RISK FACTORS","2025-08-04",{"date":280,"type":33},"2025-08-05",{"date":282,"type":33},"2024-03-26",{"date":284,"type":22},"2031-02",{"name":39,"class":40},40,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":231},"100277011","phase-3-systemic-oxaliplatin-or-intra-arterial-chemotherapy-combined-with-lv5fu2---irinotecan-and-an-target-therapy-in-first-line-treatment-of-metastatic-colorectal-cancer-restricted-to-the-liver-100277011","NCT02885753","Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +\u002F- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver","OSCAR","Inclusion Criteria:\n\n* Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)\n* At least one measurable hepatic metastasis according to the criteria RECIST v1.1\n* No other metastatic sites except lung nodules if number ≤ 3 and \\\u003C 10 mm\n* RAS mutation status known (determination of KRAS mutation (exons 2,3 and 4) and determination of the NRAS mutation (exons 2,3 and 4))\n* Age ≥ 18\n* WHO ≤ 2 (Appendix 4)\n* No prior treatment by chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months\n* Life expectancy \\> 3 months\n* PNN \\> 1500\u002Fmm3, platelets \\> 100 000\u002Fmm3, Hb \\> 9 g\u002FdLq\n* Bilirubin \\\u003C 25 mmol\u002FL, AST \\\u003C 5x ULN, ALT \\\u003C 5 x ULN, ALP \\\u003C 5 x ULN, TP \\> 60%, proteinuria from 24H \\\u003C 1 g\n* Creatinine clearance \\> 50 mL\u002Fmin according to MDRD formula (Appendix 4)\n* Patient affiliated to a social security scheme\n* Patient information and signature of the informed consent\n\nExclusion Criteria:\n\n* Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.\n* Patient immediately eligible for a curative therapy (surgical and\u002For percutaneous) after discussion in CPR\n* Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe\u002Funstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack\n* Hypertension not controlled by medical treatment (SBP \\> 140 mmHg and\u002For DBP\\> 90 mmHg with blood pressure taken according to the diagram of the HAS)\n* A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment\n* Progressive gastroduodenal ulcer, wound or fractured bone\n* Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment\n* Transplant patients, HIV positive or other immune deficiency syndromes\n* Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure\n* Peripheral neuropathy \\> 1\n* Patient with interstitial pneumonitis or pulmonary fibrosis\n* History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment\n* History of malignant pathologies during the past 5 years except basocellular skin carcinoma considered in complete remission or in situ cervical carcinoma, properly treated\n* Patient already included in another clinical trial with an experimental molecule\n* Any known specific contraindication or allergy or hypersensitivity to the drugs used in the study (cf RCP Appendix 7)\n* Known deficit in DPD\n* QT\u002FQTc range \\> 450 msec for men and \\> 470 msec for women\n* K+ \\\u003C LNL, Mg2+ \\\u003C LNL, Ca2+ \\\u003C LNL\n* Lack of effective contraception in patients (men and\u002For women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test\n* Persons deprived of liberty or under supervision\n* Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons",{"count":295,"type":22},348,[84],"Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival.\n\nThe intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance.\n\nIn conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.",[299],"Colorectal Neoplasms",[301,302,303,304],"colorectal","cancer","metastasis","hepatic","2025-07-03",{"date":307,"type":33},"2025-07-09",{"date":309,"type":33},"2016-12",{"date":311,"type":22},"2028-09",{"name":39,"class":40},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":193},"100447248","cohort-of-tumors-with-poled1-mutation-100447248","NCT05103969","Cohort of Tumors With POLE\u002FD1 Mutation","Multicenter Prospective Cohort of Tumors With Pole\u002FD1 Mutation","Inclusion Criteria:\n\n* Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R\u002FH\u002FL), 411 (V411L), 459 (S459F), 424 (L424\u002FV\u002FI), (2).\n* Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).\n\nDiagnosis made from the date of launch of the cohort and in the previous year\n\n-Age ≥ 18 years\n\nExclusion Criteria:\n\n* Tumor without POLE or POLD1 mutation\n* Tumor with POLE mutation identified in research studies retrospective research\n* Opposition of the patient to the registration of his data in the cohort",{"count":321,"type":22},100,"Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)\u002FPOLD1 mutation identified by molecular biology platforms for all stages and primary sites combined",[324,325,326],"Tumors","POLE Exonuclease Domain Mutation","POLD1 Gene Mutation","2024-07-05",{"date":329,"type":33},"2024-07-08",{"date":331,"type":33},"2021-10-05",{"date":120,"type":22},{"name":39,"class":40},{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":342,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100236395","phase-3-randomised-study-evaluating-adjuvant-chemotherapy-after-resection-of-stage-iii-colonic-adenocarcinoma-in-patients-of-70-and-over-100236395","NCT02355379","Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over","Randomised Phase III Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over Intergroup Trial: Ffcd, Gercor, Gerico, Unicancer-gi","ADAGE","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Patient considered able to receive chemotherapy\n* Lee score detailed faxed to CRGA\n* Stage III colon adenocarcinoma\n* R0 resection of the primary tumor\n* Start of the potential adjuvant chemotherapy within 12 weeks after surgery\n* No prior chemotherapy for colon cancer\n* Geriatric Self-administered questionnaire completed faxed to CRGA\n* Geriatric Questionnaire completed by the team faxed to CRGA\n* Effective contraception for men patients throughout treatment and for at least 6 months after discontinuation of oxaliplatin\n* Consent signed\n\nExclusion Criteria:\n\n* Other progressive disease (cancer uncontrolled for less than 2 years)\n* Rectal Cancer (located less than 15 cm from the anal verge endoscopy or sub-peritoneal)\n* ANC \\\u003C2000 \u002F mm3 for group 1 and ANC \\\u003C1500 \u002F mm3 for group 2 and platelets \\\u003C100,000 \u002F mm3 or hemoglobin \\\u003C9 g \u002F dL\n* Neuropathy for patients in group 1\n* Known deficit of dihydropyrimidine dehydrogenase (DPD)\n* Patients with severe hepatic insufficiency\n* Any contrindication to the drugs used in the study\n* Inability to submit to medical follow-up for geographical, social or psychological reasons.","75 Years",{"count":344,"type":22},774,[84],"Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.\n\nThe recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.\n\nAltogether there are still two matters of debate:\n\n* First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients?\n* Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy.\n\nThe elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.\n\nSome biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.",[348],"Colonic Adenocarcinoma",[350],"Adjuvant chemotherapy in colonic adenocarcinoma in elderly",{"date":329,"type":33},{"date":353,"type":4},"2015-01",{"date":355,"type":22},"2025-08",{"name":39,"class":40},140,""]