[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GERCOR - Multidisciplinary Oncology Cooperative Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":291},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,70,92,115,140,168,191,214,239,261],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100535575","phase-2-first-line-exl01-with-nivolumab-and-folfox-for-pd-l1-cps-5-metastatic-gastric-cancer-100535575",false,"NCT06253611","First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer","Gut Microbiome Intervention With EXL01 in Combination With Nivolumab and FOLFOX as First-line Treatment for Patients With PD-L1 CPS ≥5 Metastatic Gastric Cancer: A Randomized GERCOR Phase II Study (BIG)","BIG","Inclusion Criteria:\n\n1. Patients must have dated and signed an approved written informed consent form. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care.\n2. Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study,\n\n   Target Population\n3. Inoperable, advanced, or metastatic gastric cancer or gastroesophageal junction or distal esophageal carcinoma and histologically confirmed predominant adenocarcinoma,\n4. Expression of PD-L1 with a combined positive score (PD-L1 CPS) ≥5, Note: information must be available at the time of inclusion, the examination will be performed locally in the center and secondarily confirmed centrally,\n5. No prior systemic cancer treatment given as primary therapy for advanced nonresectable or metastatic disease, Note: if patient received neoadjuvant\u002Fadjuvant therapy, this therapy should be completed at least 6 months prior to the diagnosis of metastatic or recurrent disease is made. Palliative radiotherapy is allowed and must be completed 2 weeks prior to randomization,\n6. At least one measurable lesion as assessed by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and feasibility of repeated radiological assessments; radiographic tumor assessment should be performed within 28 days prior to randomization,\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1,\n8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization of study treatment:\n\n   1. White blood cell ≥ 2000\u002FμL;\n   2. Neutrophils ≥ 2000\u002FμL;\n   3. Platelets ≥ 100.000\u002FμL;\n   4. Hemoglobin ≥ 9.0 g\u002FdL;\n   5. Serum albumin ≥ 30 g\u002FL;\n   6. Serum creatinine level ≤ 150 μM and calculated creatinine clearance (Cockcroft-Gault) \\> 50 mL\u002Fminute,\n   7. Total bilirubin ≤ 1.5 x upper normal limit (ULN);\n   8. Alanine aminotransferase (ALT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present);\n   9. Aspartame aminotransferase (AST) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present);\n   10. Potassium ≥ 1.0 x lower limit of normal (LLN),\n   11. Magnesium ≥ 1.0 x LLN,\n   12. Calcium ≥ 1.0 x LLN,\n9. Baseline-corrected QT interval ≤ 450 msec for males and ≤ 470 msec for females,\n10. Availability of a representative tumor tissue specimen for exploratory translational research; tumor tissue samples, either formalin- fixed paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections (minimum of 20 positively charged slides) from primary or metastatic site must be submitted to the central laboratory,\n11. Registration in a national health care system (PUMa-Protection Universelle Maladie included.\n\n    Age and reproductive status\n12. Age ≥ 18 years,\n13. Women must not be pregnant, breastfeeding, or expecting to conceive during the study,\n14. Reproductive status:\n\n    1. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study drug,\n    2. WOCBP must agree to use an adequate method of contraception or birth control for the duration of study treatment and 5 months (nivolumab), 9 months (oxaliplatin), 6 months (5-FU) or at least 1 month (EXL01) of the patient's last dose of the study drug,\n    3. Males who are fertile and sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 6 months (nivolumab, oxaliplatin, or 5-FU) or at least 1 month (EXL01) after the last dose of study treatment. In addition, males must be willing to refrain from sperm donation during this time,\n\nExclusion Criteria:\n\nTarget Disease Exceptions\n\n1. Known HER-2 positive status or unknown HER-2 status before inclusion,\n2. Active brain metastases or known history of leptomeningeal carcinomatosis,\n3. Ascites, which cannot be controlled with appropriate interventions,\n\n   Exclusion criteria related to medical history and concurrent disease\n4. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast,\n5. Active, known, or suspected autoimmune disease; type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted,\n6. Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity,\n7. Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co- stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents,\n8. Condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days (2 weeks) of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone equivalent, are permitted prior to randomization in the absence of active autoimmune disease,\n9. Persistence of toxicity (The National Cancer Institute Common Terminology Criteria for Adverse Event \\[NCI CTCAE\\] v 5.0) grade \\>1 related to prior anticancer treatments,\n10. Major surgery within 28 days (4 weeks) prior to first dose of study treatment, 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.\n11. Concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy),\n\n    Exclusion criteria related to EXL01\n12. GI obstruction, poor oral intake, or difficulty in taking oral medication or difficulties in swallowing; nasogastric tubes are not permitted,\n13. Known GI malabsorption,\n14. Is currently participating in or has participated in a study with an investigational compound within 28 days prior to the first dose of study treatment, 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,\n15. Prior allogeneic bone marrow transplantation or prior solid organ transplantation,\n16. Fecal microbiota transplant within 3 months prior to screening, Note: Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention.\n17. Current probiotics administration, or planned probiotics administration during treatment course is not allowed, Note: The following therapies should be avoided during the study; however, they are not prohibited if, in the assessment of the\n\n    Investigator, they are required for clinical management:\n    * Nonsteroidal anti-inflammatories,\n    * Antacids,\n    * Proton-pump inhibitors.\n18. Excessive alcohol intake: moderate consumption, defined as no more than 1 drink per day for women and no more than 2 drinks per day for men, is permitted,\n19. Known allergy and\u002For hypersensitivity to any component or excipients of study treatments (nivolumab, EXL01), any other live pro- biotherapeutic product, and\u002For to soybean or soy-containing products,\n20. Known history or newly diagnosed GI parasitic infection within 3 months prior to screening, Note: Patients must have recovered adequately from the toxicity and\u002For complications from the treatment prior to starting study intervention,\n21. 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 (according to exclusion criteria n°8),\n\n    Exclusion criteria related to chemotherapy\n22. Active or chronic hepatitis B virus (HBV), hepatitis C virus (HCV) and\u002For human immunodeficiency virus infection (HIV 1\u002F2 antibodies).\n\n    Participants are eligible if they:\n    * Have controlled HCV load defined as undetectable hepatitis C RNA by polymerase chain reaction either spontaneously or in response to a successful prior course of anti-hepatitis C therapy,\n    * Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis,\n    * Are HBV surface antigen (HBsAg)- and anti- Hepatitis B core antibody (HBc)+ (i.e., those who have cleared HBV after infection),\n    * Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions below:\n\n      * HBV DNA viral load \\\u003C100 IU\u002FmL,\n      * Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HBV infection,\n      * Start or maintain antiviral treatment if clinically indicated as per the investigator,\n23. Any (attenuated) live vaccine use within 28 days (4 weeks) prior to randomization, while in the study; live vaccines include, but are not limited to, the following: yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza,\n24. Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine,\n25. Dihydropyrimidine dehydrogenase deficiency (DPD; uracilemia dosage \\>16 ng\u002Fml), Uracilemia dosing results must be available before inclusion,\n26. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results,\n27. Known peripheral sensory neuropathy with functional impairment according exclusion criteria n°9) prior to first treatment, according to the Summary of product characteristics (SmPC) of oxaliplatin,\n28. Known potentially serious infection, according to the SmPC of 5-FU\n29. Has clinically significant active heart disease or myocardial infarction within 6 months given the cardiotoxicity of 5-FU, according to the SmPC of 5-FU,\n30. Known history of hypersensitivity to 5-FU, oxaliplatin, or leucovorin, or to any of their excipients, according to the SmPCs of these products.\n\n    Exclusion criteria related to geographical, social, and legal issues\n31. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness,\n32. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his\u002Fher consent.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized non-comparative, multicenter phase II study in patients with PD-L1 PD-L1 combined positive score (CPS) ≥5 advanced gastric cancer to evaluate the efficacy and safety of nivolumab and FOLFOX in combination with EXL01 as first-line treatment.\n\nAfter signing the informed consent form, and upon confirmation of the patient's eligibility, patients will be randomized in a 2:1 ratio to either the nivolumab and FOLFOX plus EXL01 arm (experimental) or the nivolumab and FOLFOX arm (control). In both arms, treatment will be given until PD, unacceptable toxicity or for a maximum of 24 months (52 cycles).",[27],"Gastric Cancer","RECRUITING","2025-09-16",{"date":31,"type":32},"2025-09-22","ACTUAL",{"date":34,"type":32},"2024-04-16",{"date":36,"type":21},"2029-04",{"name":38,"class":39},"GERCOR - Multidisciplinary Oncology Cooperative Group","OTHER",37,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100504576","acupuncture-for-oxaliplatin-induced-peripheral-neuropathy-in-gastro-intestinal-cancer-patients-100504576","NCT05850130","Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients","A Multicenter, 2-cohort Phase II GERCOR Study to Evaluate the Interest of Acupuncture on Oxaliplatin-induced Peripheral Neuropathy in Patients With Gastro-intestinal Solid Tumors Who Discontinued Oxaliplatin-based Chemotherapy (ACUPOX)","ACUPOX","Inclusion Criteria\n\nPatient is included if:\n\n1. Agree to participate in this study, voluntarily signing a written informed consent form,\n2. Aged ≥ 18 years,\n3. Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2,\n4. Have histologically or cytologically confirmed gastro-intestinal solid tumors, previously treated with any oxaliplatin-based chemotherapy; a concomitant radio-chemotherapy course is allowed,\n5. Had the last oxaliplatin infusion \\> 2 weeks before inclusion,\n6. Present OIPN with a numerical rating score (NRS) ≥ 4\u002F10 at inclusion,\n7. Currently receiving or recently completed chemotherapy (adjuvant, neoadjuvant, or advanced stage). Patients may receive current chemotherapy treatment (e.g., with FOLFIRI, 5-fluorouracil, bevacizumab regimens), excluding platinum salts and taxane-based regimens during the study,\n8. Are able to understand\u002Fread French,\n9. Are registered in a national health care system (PUMa - Protection Universelle Maladie included),\n\nExclusion Criteria\n\nPatients is excluded if:\n\n1. Had acupuncture sessions for the prevention of chemotherapy-induced side effects in the last 3 months prior to inclusion,\n2. Had previous and\u002For current chemotherapy treatments with taxane-based regimens (e.g., the TFOX regimen \\[docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil\\]),\n3. Have a history of preexisting clinically-significant peripheral neuropathy due to any cause other than chemotherapy (borrelia infection, human immunodeficiency virus infection, hereditary factors, tumor compression, nutritional deprivation, alcohol, diabetes, etc.),\n4. Have a recent history (within 4 weeks prior to start of acupuncture) of abusing alcohol, prescription, or illicit drugs (including cannabinoid), or medical, psychological, or social conditions that may interfere with the patient's compliance with the study intervention, NB: The patient should be informed that drinking alcohol should be avoided while on study.\n5. Have any other condition that, in the opinion of the investigator, is unstable or could jeopardize the safety of the patient and her\u002Fhis compliance during the study,\n6. Have limb edema of grade 3 (CTCAE v5),\n7. Had phytotherapy within 2 weeks before a week 1-14 intervention,\n8. Are pregnant or breastfeeding,\n9. Are under the tutorship or guardianship of the state or in custody of the justice system.",{"count":50,"type":21},182,[52],"NA","ACUPOX is a multicenter, open label, 2-cohort based phase II clinical study evaluating the interest of a standardized protocol of verum acupuncture in treatment of Oxaliplatin-induced peripheral neuropathy in patients with gastro-intestinal solid tumors who discontinued oxaliplatin-containing chemotherapy.",[55,56,27,57,58],"Colorectal Cancer","Liver Cancer","Pancreas Cancer","Esophagus Cancer",[60],"acupuncture","2025-07-22",{"date":63,"type":32},"2025-07-23",{"date":65,"type":32},"2023-11-22",{"date":67,"type":21},"2027-12",{"name":38,"class":39},5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100499741","ctdna-in-crc-patients-undergoing-curative-intent-surgery-for-liver-metastases-100499741","NCT05787197","ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases","Circulating Tumor DNA in Patients With Colorectal Cancer Undergoing Curative-intent Surgery for Liver Metastases: Prospective, Multicenter, GERCOR Cohort","CLIMES","Inclusion criteria\n\nThe patient will be included if:\n\n1. Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,\n2. Is ≥ 18 years of age,\n3. Has histologically confirmed colorectal adenocarcinoma,\n4. Has resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,\n5. Has isolated CRLM that is deemed resectable or potentially resectable (extrahepatic metastases excluded, except infracentimetric non-specific lung lesions with largest diameter \\\u003C1 cm and maximal number of ≤3) as judged by a multidisciplinary team meeting (based on CT scans of chest, abdomen, and pelvis \\[or MRI if CT not possible\\]),\n6. Is eligible to surgical procedure,\n7. Is fit for the chemotherapy-surgery combination treatment,\n8. Is registered in a national health care system (Protection Universelle Maladie \\[PUMa\\] included).\n\nExclusion criteria\n\nThe patient will be excluded if:\n\n1. Has definitively unresectable CLRM,\n2. Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,\n3. Has not resected primary rectal tumor (low and middle),\n4. Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,\n5. Has no more than two surgical procedures planned for complete resection of primary tumor and\u002For liver metastases,\n6. Has deficient mismatch repair (dMMR)\u002F microsatellite instability (MSI) tumors treated with immunotherapy,\n7. Blood samples cannot be collected if surgical procedure,\n8. Is pregnant or breastfeeding,\n9. Cannot be followed-up due to geographical, social, or psychic conditions,\n10. Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,\n11. Is under guardianship, curatorship, or under the protection of justice.",{"count":79,"type":21},232,"OBSERVATIONAL","This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.",[83,84],"Metastatic Colorectal Cancer","Circulating Tumor DNA",{"date":63,"type":32},{"date":87,"type":32},"2024-01-09",{"date":89,"type":21},"2027-06-30",{"name":38,"class":39},16,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100434340","prognostic-and-predictive-markers-of-response-to-treatment-in-patients-with-bile-duct-cancer-acabi-pronobil-study-100434340","NCT04935853","Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study","Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL","Inclusion Criteria:\n\n* All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of the gallbladder; ampullomas excluded)\n* Age \\> 18 years\n* Diagnosed between 2003 and 2030 (minimum follow-up 2 years)\n* Written written non-opposition +\u002F- signed informed consent for genetic studies (N.B.:\n\nexemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol\n\nExclusion Criteria:\n\n* Patient under guardianship, curatorship or legal protection\n* Pregnant or breastfeeding women\n* Any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment\n* Refusal to participate in the study",{"count":100,"type":21},1350,"The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.",[103],"Biliary Tract Cancer",[105,106,107],"predictive","prognostic","biliary track cancer",{"date":63,"type":32},{"date":110,"type":32},"2022-05-23",{"date":112,"type":21},"2040-06-01",{"name":38,"class":39},32,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100383091","phase-2-efficacy-of-neoadjuvant-chemotherapy-in-terms-of-dfs-in-patients-with-localized-digestive-neuroendocrine-carcinomas-100383091","NCT04268121","Efficacy of Neoadjuvant Chemotherapy in Terms of DFS in Patients With Localized Digestive Neuroendocrine Carcinomas","Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas","NEONEC","Inclusion Criteria:\n\nPhase II\n\n1. Histologically proven digestive CNE, (the WHO 2017 classification: poorly differentiated and Ki 67 \\> 20%),\n2. Patients with localized CNE, without metastasis (computed tomography \\[CT\\], thoraco-abdominopelvic CT scan \\[TAP\\] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),\n3. Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and\u002For bone disorders, 4. Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,\n\n5\\. Age ≥ 18 years, 6. Written informed consent obtained from the patient, willing and able to comply with the protocol, 7. Registration in a National Health Care System (Protection Universelle Maladie \\[PUMa\\] included), 8. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nProspective cohort\n\n1. Patients with localized digestive CNE histologically proven on the operative specimen (the WHO 2017 classification: poorly differentiated and Ki 67\\> 20%),\n2. Localized, without metastasis on computed tomography \\[CT\\], thoracoabdominopelvic CT scan \\[TAP\\] RECIST 1.1, and\u002For locoregional lymph node involvement,\n3. Age ≥ 18 years,\n4. Written informed consent obtained from the patient, willing and able to comply with the protocol,\n5. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included),\n6. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.\n\nMen and women are required to use a reliable and adequate birth control methods during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration.\n\nExclusion Criteria:\n\nPhase II\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law\n\nProspective cohort\n\n1. Well-differentiated NEC, whatever the grade,\n2. Metastatic disease,\n3. Cancer of unknown primary\n4. Organ failure that does not allow chemotherapy treatment,\n5. Previous malignancy within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ\n6. Tumor with a mixed component (component accounts for ≥ 30%),\n7. Patient impossible to follow-up,\n8. Other than platinum-etoposide chemotherapy administrated,\n9. Tutelage or guardianship or patient protected by law.",{"count":124,"type":21},78,[24],"NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery.\n\nThe objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy.\n\nIn parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).",[128,129],"Neuroendocrine Carcinoma","Digestive Cancer",[131,132],"Neoadjuvant treatment","Adjuvant treatment",{"date":63,"type":32},{"date":135,"type":32},"2021-01-05",{"date":137,"type":21},"2031-01",{"name":38,"class":39},14,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100598465","phase-2-between-biweekly-bevacizumab--trifluridinetipiracil-to-reduce-grade-3-4-neutropenia-in-mcrc-patients-100598465","NCT07071844","BETWEEN: Biweekly Bevacizumab + Trifluridine\u002FTipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients","BEvacizumab Plus Trifluridine\u002FTipiracil in a Bi-WEEkly Administration to Reduce Grade 3-4 Neutropenia in Patients With mCRC: A Prospective, Multicenter, Comparative, Randomized GERCOR G-124 BETWEEN Phase II Study","BETWEEN","Inclusion Criteria:\n\n1. Signed and dated informed consent,\n2. Patients willing and able to comply with protocol requirements,\n3. Age ≥ 18 years,\n4. ECOG PS 0-1,\n5. Histologically proven colorectal adenocarcinoma,\n6. Stage IV disease,\n7. Previous chemotherapy regimens with each of the following agents: fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy (bevacizumab, aflibercept, and anti-EGFR therapy (cetuximab or panitumumab for tumors with RAS and\u002For BRAF wild-type),\n8. Tumor assessment (CT-scan or MRI) no later than 21 days prior to treatment - at least one measurable or evaluable lesion as assessed by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to RECIST,\n9. Known BRAF and RAS mutational status, and microsatellite instability\u002Fmismatch repair deficiency (MSI\u002FdMMR) status,\n10. Have life expectancy of at least 3 months,\n11. Adequate hematologic function: neutrophils \\>1.5 x 10\\^9\u002FL; platelets \\>100 x 10\\^9\u002FL; hemoglobin ≥ 9 g\u002FdL,\n12. Adequate renal function: Calculated (regardless of the calculation method) creatinine clearance (CrCl) ≥30 mL\u002Fmin), proteinuria \\\u003C 2+ (dipstick urinalysis) or ≤1g \u002F 24h,\n13. Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit normal (ULN; ≤5 x ULN in case of liver metastasis), total bilirubin ≤1.5 x ULN (\\\u003C2 x ULN if hyperbilirubinemia is due to Gilbert's syndrome), albumin ≥25 g\u002FL,\n14. Clinical and blood baseline evaluations no later than 14 days prior to treatment,\n15. Ability to swallow oral tablets,\n16. Women must be surgically sterile or postmenopausal, or not be pregnant, breastfeeding, or expecting to conceive during the study. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to starting trifluridine\u002Ftipiracil treatment. WOCBP must agree to use an adequate method of contraception or birth control for the duration of study treatment and least 6 months (trifluridine\u002Ftipiracil, bevacizumab) after the last dose of the study treatment,\n17. Males who are fertile and sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and at least 6 months (trifluridine\u002Ftipiracil, bevacizumab) after the last dose of the study treatment.\n18. Is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,\n19. Registration with the French National Health Care System or PUMA (Protection Universelle Maladie).\n\nExclusion Criteria:\n\n1. ECOG PS 2,\n2. Medical history or evidence of CNS metastasis upon physical examination, unless adequately treated (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, patients are stable without evidence of progression for at least 28 days prior to inclusion),\n3. Local or locally advanced disease (stage I to III),\n4. Concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),\n5. Unresolved grade ≥3 non-hematologic toxicity related to previous chemotherapy regimen (excluding alopecia and skin pigmentation),\n6. Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia dosage \\>16 ng\u002Fml); Uracilemia dosing results must be available before inclusion,\n7. Treatment with warfarin,\n8. Treatment with any other investigational medicinal product (IMP) within 28 days prior to inclusion,\n9. Symptomatic carcinomatosis with occlusive symptoms or ascites requiring paracentesis,\n10. Other serious and uncontrolled non-malignant disease (e.g., active infection requiring systemic therapy, coronary stenting or myocardial infarction, or stroke in the past 6 months prior inclusion),\n11. Severe or uncontrolled active acute or chronic infection,\n12. Major surgery within 28 days (4 weeks) prior to inclusion,\n13. Gastrointestinal disease that could potentially interfere with study drug absorption,\n14. Uncontrolled diabetes mellitus, hypertension, or cardiac arrhythmia,\n15. Active (or history of) interstitial lung disease or pulmonary hypertension,\n16. Major adverse cardiovascular event within 6 months prior to inclusion,\n17. Severe\u002Funstable angina, or NYHA class III or IV heart failure,\n18. Systemic immunosuppressive therapy, except steroids given prophylactically or at chronic low dosage (≤20 mg\u002Fday prednisone equivalent),\n19. Radiotherapy within 28 days (4 weeks) before randomization, except for palliation,\n20. Serious nonhealing wound, ulcer or bone fracture,\n21. Deep vein thromboembolic event within 28 days (4 weeks) prior to inclusion,\n22. Known clinically relevant coagulopathy, bleeding diathesis or bleeding event within 28 days (4 weeks) prior to inclusion,\n23. Malignant disease other than mCRC,\n24. Other concomitant or previous malignancy, except i\u002F adequately treated in-situ carcinoma of the uterine cervix, ii\u002F basal or squamous cell carcinoma of the skin, iii\u002F cancer in complete remission for \\>5 years,\n25. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.\n\n    Note: In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided, if possible.\n\n    Note: Caution is required when using medicinal products that are human thymidine kinase substrates, e.g., zidovudine. Such medicinal products, if used concomitantly with trifluridine\u002Ftipiracil, may compete with the effector, trifluridine, for activation via thymidine kinases. Therefore, when using antiviral medicinal products that are human thymidine kinase substrates, monitor for possible decreased efficacy of the antiviral medicinal product, and consider switching to an alternative antiviral medicinal product that is not a human thymidine kinase substrate, such as lamivudine, didanosine, and abacavir.\n\n    Note: It is unknown whether trifluridine\u002Ftipiracil may reduce the effectiveness of hormonal contraceptives. Therefore, women using hormonal contraceptive must also use a barrier contraceptive method.\n26. Human immunodeficiency virus (HIV)-infected patients or otherwise known to be HIV-positive,\n27. Untreated hepatitis B virus (HBV) or hepatitis C virus (HCV),\n28. Concomitant administration of prophylactic phenytoin and live attenuated virus vaccine such as yellow fever vaccine 28 days (4 weeks) prior to treatment,\n29. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness,\n30. Under legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapability of giving consent.",{"count":149,"type":21},162,[24],"This study was design to:\n\n* To assess the impact of a biweekly (experimental arm) compared to a conventional administration (control arm) on the rate of grade 3-4 neutropenia in metastatic colorectal cancer (mCRC) patients treated with trifluridine\u002Ftipiracil plus bevacizumab, and\n* To identify predictive clinical and biological factors for grade 3-4 neutropenia in this patient population.",[83],[154,155,156,157],"Trifluridine\u002FTipiracil","metastatic colorectal cancer","neutropenia","bevacizumab","NOT_YET_RECRUITING","2025-07-15",{"date":161,"type":32},"2025-07-17",{"date":163,"type":21},"2025-09",{"date":165,"type":21},"2029-12",{"name":38,"class":39},10,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100595128","phase-2-panoramix--optimizing-1st-line-nalirifox-and-exploring-microbiotas-role-in-2nd-line-pancreatic-cancer-treatment-100595128","NCT07028424","PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment","Pancreatic Cancer First-line NALIRIFOX Optimization With 5-FU Maintenance and Role of Antibiotics and Microbiota Exploration in Second-line Treatment - A Non-comparative, Randomized Phase II PANORAMIX GERCOR G-116 PRODIGE 105 Study.","PANORAMIX","Inclusion Criteria:\n\nOverlapping inclusion criteria for STEP 1 AND STEP 2\n\n1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations (only after interim analysis at Step 2 for patients who were not randomized in first randomization \\[R1\\]),\n2. Age ≥18 years old. STEP 1: The patient over 75 years of age is eligible only if the patient's G8 score (G8 questionnaire) is \\> 14,\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1,\n4. Histologically or cytologically proven PDAC,\n5. ≥1 measurable lesion according to RECIST v 1.1 (Computed tomography thorax-abdomen-pelvis \\[TAP-CT\\] scan ≤ 4 weeks), Note: abdominal magnetic resonance imaging (MRI) is allowed (e.g., in case of contra-indication to CT scan contrast injection) provided that this imaging modality is used consistently throughout the tumor evaluations,\n6. Availability of archival tissue samples for exploratory research. Step 2: can be the same as in Step 1 or it can be newly obtained sample,\n7. Adequate organ function, obtained within 21 days prior to randomization of study treatment, as defined by the following:\n\n   * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN; ≤ 5 x ULN in case of liver metastases) - STEP 2, if paclitaxel administration,\n   * Total serum bilirubin \\\u003C 1.5 x ULN (STEP 2, if paclitaxel administration),\n   * Serum albumin ≥ 28 g\u002FL,\n   * Hemoglobin ≥ 9.0 g\u002Fdl,\n   * Absolute neutrophil count (ANC) ≥ 2 x 10\\^9L,\n   * Platelets - STEP 1: ≥ 150 x 10\\^9L; STEP 2: ≥ 100 x 10\\^9L,\n   * Creatinine clearance ≥ 50 mL\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\]),\n8. Evidence of post-menopausal status or negative serum pregnancy test within 7 days before starting study treatment for female pre- menopausal patients. Women of childbearing potential (WOCBP) should use effective contraception during study treatment and: 1 month (paclitaxel), 6 months (5FU, LV), 7 months (NAL-IRI), 15 months (oxaliplatin), and 6 months (gemcitabine+\u002F-paclitaxel and ciprofloxacin\u002Fplacebo) after the patient's last dose of treatment. Males who are fertile should use effective contraception during study treatment and 4 months (NAL-IRI), 6 months (5-FU, LV), 12 months (oxaliplatin), and 6 months (gemcitabine+\u002F-paclitaxel and ciprofloxacin\u002Fplacebo) after the patient's last dose of treatment.\n9. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up,\n10. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included).\n\n    Distinct inclusion criteria for STEP 1 and STEP 2 STEP 1\n11. No prior first-line chemotherapy (5-FU or gemcitabine based, or FOLFIRINOX) for metastatic disease; if treatment with any investigational medicinal product (IMP) the delay before the last dose and inclusion more than or equal to 28 days, Note: relapse after FOLFIRINOX adjuvant chemotherapy in case of resectable disease is NOT allowed,\n12. No dihydropyrimidine dehydrogenase (DPD) deficiency (Uracilemia dosage \\>16 ng\u002Fml), Uracilemia dosing results must be available before inclusion).\n\nSTEP 2 11. Metastatic disease, 12. L2 therapy after progression under 5-FU-based chemotherapy for localized\u002Flocally advanced or metastatic stage, Note: relapse \\\u003C4 months after the end of adjuvant chemotherapy in case of resectable disease is allowed.\n\nExclusion Criteria:\n\nOverlapping exclusion criteria for STEP 1 AND STEP 2\n\n1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study,\n2. History of allogenic organ transplantation or active autoimmune, connective tissue disorder, or inflammatory disease requiring systemic treatment,\n3. Diagnosis of any second malignancy that required any treatment within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,\n4. History of idiopathic pulmonary fibrosis, interstitial lung disease (ILD), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening (TAP-CT-scan),\n5. Current systemic steroid therapy (\\>10 mg daily dose of prednisone or equivalent; minimal wash-out of 1 week \\[7 days\\]) or immunosuppressive therapy,\n6. Prior radiotherapy treatment to more than 30% of the bone marrow or a wide field of radiation within 4 weeks (30 days) prior to the first dose of study drug,\n7. Major surgical procedure (as defined by the Investigator) within 4 weeks (30 days) prior to the first dose of trial treatment (Step 1 and Step 2), Note: Local surgery of isolated lesions for palliative intent is acceptable,\n8. Uncontrolled central nervous system metastases and\u002For carcinomatous meningitis,\n9. Uncontrolled massive pleural effusion or massive ascites,\n10. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions (e.g. bleeding, inflammation, occlusion, malabsorption syndrome, ulcerative colitis, gastrointestinal ulceration, infection or sepsis, inflammatory bowel disease or partial bowel obstruction) associated with diarrhea, or geographical\u002Fsocial\u002F psychiatric illness situations that would limit compliance with study requirement and study follow-up, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent,\n11. History or current evidence of any condition, therapy, laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant in the opinion of the treating investigator,\n12. QT\u002FQTc interval \\>470 ms (for women) and \\> 450 ms (for men), previous ventricular arrhythmia, known or suspected long-QT syndrome, Note: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: \u002F\u002Fwww.crediblemeds.org.\")\n13. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients,\n14. Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (HBV, known positive HBV surface antigen \\[HbsAg\\] result), hepatitis C (HBC, with positive RNA), or human immunodeficiency virus (HIV positive 1\u002F2 antibodies), 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; patients with previously treated and cured HCV infection (negative RNA) are also eligible,\n15. Live vaccine administration within 4 weeks (30 days) prior to the first dose of study treatment,\n16. Pregnancy\u002Fbreast-feeding\u002Flactation,\n17. Under a legal protection measure (guardianship, curatorship, or judicial safeguard), administrative decision, and\u002For incapable of giving his\u002Fher consent.\n\nDistinct exclusion criteria for STEP 1 and STEP 2 STEP1 18. Any unresolved NCI CTCAE toxicity of grade ≥ 2 from previous anticancer therapy (including peripheral neuropathy of grade ≥ 1) except for alopecia or vitiligo, 19. Any previous chemotherapy for advanced disease, 20. Uncontrolled central nervous system metastases and\u002For carcinomatous meningitis, 21. Peripheral neuropathy with functional discomfort \\> grade 2, 22. Clinically significant active heart disease or myocardial infarction within 6 months given the cardiotoxicity of 5-FU, 23. Abnormal values of potassium, magnesium, and calcium levels at inclusion, 24. Patients with known homozygous UGT1A1\\*28 (Gilbert's disease), 25. Any use of strong CYP3A4 inducers\u002Finhibitors and\u002For strong UGT1A1 inhibitors (patients are ineligible if unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving first dose of NAL-IRI injection), or presence of any other contraindications for irinotecan), 26. Brivudine-based treatment within 4 weeks preceding treatment initiation. STEP 2 18. Antibiotics use in the month before the day of treatment initiation or for \\> 5 days within 3 months before the day of treatment initiation, 19. Previous gemcitabine-based chemotherapy, 20. Known previous colonization or infection with K. pneumoniae resistant to quinolones, 21. Prophylactic phenytoin within 1 week (7 days) prior to the first dose of study treatment, 22. Any contra-indication to ciprofloxacin: history of fluoroquinolone-related severe side effects (muscle, tendons, joint…), severe aortic disease (aneurysm, dissection), myasthenia, epilepsy, 23. Inability to take oral treatment, 24. Concomitant medication with CYP1A2 substrates (e.g., theophylline, clozapine, duloxetine, tizanidine, olanzapine, propranolol, amitryptilin, and methotrexate, 25. Known glucose-6-phosphate dehydrogenase deficiency.",{"count":177,"type":21},206,[24],"The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.",[181],"PDAC - Pancreatic Ductal Adenocarcinoma","2025-06-26",{"date":184,"type":32},"2025-07-01",{"date":186,"type":21},"2025-07",{"date":188,"type":21},"2030-12",{"name":38,"class":39},12,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100463126","phase-2-nivolumab-and-ipilimumab-in-anti-pd1-resistant-dmmrmsi-mcrc-100463126","NCT05310643","Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR\u002FMSI mCRC","Nivolumab and Ipilimumab in Patients With dMMR and\u002For MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial (NIPIRESCUE)","NIPIRESCUE","Inclusion Criteria:\n\n1. Signed and dated patient informed consent form and willingness to comply with all study procedures and availability for the study duration,\n2. Age ≥ 18 years,\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, and 2,\n4. Histologically confirmed colorectal adenocarcinoma,\n5. Documented metastatic disease not suitable for complete surgical resection,\n6. Disease progression per iRECIST criteria (i.e., iCPD: immune confirmed PD) during monotherapy with anti-PD1 monoclonal antibody or less than 6 months after the discontinuation of anti-PD1 monoclonal antibody\n7. Disease progression during, after, or patients who are intolerant or have contraindications to approved standard therapies for the metastatic disease, which must include at least: • Fluoropyrimidine, oxaliplatin, and irinotecan, • Anti-EGFR therapy if wild-type RAS, • Anti-VEGF therapy,\n8. At least one measurable lesion as assessed by CT-scan or magnetic resonance imaging (MRI) according to RECIST 1.1 and feasibility of repeated radiological assessments,\n9. dMMR and\u002For MSI tumor status defined by: - Loss of MMR protein expression using immunohistochemistry with four (anti-MLH1, anti-MSH2, anti-MSH6, and anti-PMS2) antibodies, - and\u002For ≥ two unstable markers by pentaplex polymerase chain reaction (BAT-25, BAT-26, NR-21, NR-24, and NR-27), NB: In case of loss of expression of only one MMR protein immunohistochemistry, it is necessary to confirm the tumor is MSI using pentaplex PCR.\n\n   NB: In cases with two unstable markers, comparison with matching normal tissue is required.\n\n   NB: Agreement of the Sponsor (GERCOR) is mandatory to include the patient (the patient's file will be verified to confirm MSI\u002FdMMR status before inclusion \\[an anonymized fax\\] and confirmation of a patient's allocation will be sent by mail to the Investigator within 24h).\n10. For all patients, a new biopsy must be performed to obtain fresh anti-PD1 resistant tumor tissue prior to study treatment initiation,\n11. For all patients, archival formalin-fixed paraffin-embedded tissue (FFPE) blocks and\u002For FFPE unstained slides (minimum of 30 positively charged slides representative of tumor tissue and non-tumor adjacent prior to anti-PD1 therapy (i.e., primary or metastatic site naïve of immunotherapy) must be submitted to the central laboratory,\n12. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior inclusion: - Adequate hematological status (White blood cell \\> 2000\u002FμL; o Neutrophils \\> 1500\u002FμL; Platelets \\> 100.000\u002FμL; Hemoglobin \\> 10.0 g\u002FdL; - Adequate renal function: Serum creatinine level \\\u003C 120 μM; Clearance \\> 50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault, - Adequate liver function: Serum bilirubin ≤ 1.5 x upper normal limit (ULN); Alkaline phosphatase (ALP) ≤ 3.0 x ULN; Alanine aminotransferase (ALT) ≤ 3.0 x ULN; Aspartate aminotransferase (AST) ≤ 3.0 x ULN; Hemostasis: Prothrombin time (PT)\u002FInternational normalized ratio (INR) and activated partial PT (aPTT) ≤ 1.5 x ULN unless participants are receiving anticoagulant therapy and their INR is stable and within the recommended range for the desired level of anticoagulation,\n13. Females of childbearing potential must have negative serum pregnancy test within 7 days before starting study treatment,\n14. Women of childbearing potential should use effective contraception during treatment and at least 5 months thereafter.\n15. Registration in a national health care system (Protection Universelle Maladie \\[PUMa\\] included)\n\nExclusion Criteria:\n\n1. Known brain metastases or leptomeningeal metastases,\n2. Persistence of toxicities related to prior treatments (chemotherapies or anti-P1 therapies) grade \\> 1 (NCI CTCAE v 5.0; except dysthyroidism, adrenal gland deficiency, alopecia, fatigue or oxaliplatin-induced peripheral sensory neuropathy which can be ≥ grade 2),\n3. Discontinuation of anti-PD1 treatment due to treatment-related adverse event (AE) grade \\> 2 (NCI CTCAE v 5.0),\n4. Prior treatment with an anti-LAG-3, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, except anti-PD1 antibodies,\n5. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy),\n6. Major surgical procedure within 4 weeks prior to initiation of study treatment,\n7. Patients receiving any investigational drug, biological, immunological therapy within the previous 21 days before study treatment,\n8. Patients with an active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to be enrolled,\n9. History of interstitial lung disease or pneumonitis,\n10. Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of inclusion.\n\n    NB : Exceptions to this criterion: - Inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease, - Systemic corticosteroids at physiologic doses not exceeding strictly 10 mg\u002Fday of prednisone or its equivalent,\n11. Prior malignancy active within the previous 3 years, except for: - Locally curable cancers that have been apparently cured (e.g. squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast), - Lynch syndrome-related non-colorectal cancer in complete remission for \\> 1 year,\n12. Active hepatitis B (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test prior to randomization) virus (HBV) or hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing is negative for HCV ribonucleic acid.\n13. Prior allogeneic bone marrow transplantation or prior solid organ transplantation,\n14. Any serious or uncontrolled medical disorder that, in the opinion of Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results,\n15. Known allergy\u002Fhypersensitivity to any component of study agents,\n16. Administration of a (attenuated) live vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,\n17. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his\u002Fher consent,\n18. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.",{"count":200,"type":21},30,[24],"NIPIRESCUE evaluates nivolumab and ipilimumab in patients with MSI\u002FdMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.",[83],[205,206],"dMMR","MSI",{"date":184,"type":32},{"date":209,"type":32},"2022-05-05",{"date":211,"type":21},"2027-09",{"name":38,"class":39},9,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":238,"locationsCount":167},"100565766","phase-2-neoadjuvant-pembrolizumab-with-a-watch-and-wait-strategy-for-dmmrmsi-h-localized-colon-cancer-premices-study-100565766","NCT06646445","Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR\u002FMSI-H Localized Colon Cancer: PREMICES Study.","Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for Patients With Mismatch Repair-deficient or Microsatellite Instability-high (dMMR\u002FMSI-H) Localized Colon Cancer: a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial","PREMICES","Inclusion Criteria:\n\n1. Signed and dated informed consent (IC),\n2. Aged ≥18 years,\n3. An Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1,\n4. Newly diagnosed, histologically confirmed colonic or upper third rectal adenocarcinoma, NB: material must be available from biopsy done during colonoscopy.\n5. Radiological tumor assessment at screening performed within 21 days before inclusion according to RECIST v1.1 by chest, abdomen, and pelvis (TAP- CT) showing resectable localized disease (cT0-4 cN0-2 cM0) and no metastatic disease,\n6. dMMR and\u002For MSI-high (MSI-H) tumor status as follows:\n\n   * loss of expression of ≥1 MMR protein (MLH1, MSH2, MSH6, or PMS2) or a dimeric couple (MLH1 and PMS2 or MSH2 and MSH6) on immunohistochemistry (IHC; using hMLH1, hMSH2, hMSH6, hPMS2 antibodies),\n   * And\u002For ≥ 3 instable markers by the pentaplex by polymerase chain reaction (PCR) (BAT-25, BAT-26, NR-21, NR-24, and NR-27),\n\n   NB:\n   * In case of two instable markers by PCR, it is required to present confirmation of the dMMR status by IHC or comparison of PCR test with matched normal tissue.\n   * In case of loss of expression of only one MMR protein by IHC or any other IHC pattern, it is required to confirm MSI status using pentaplex PCR; Agreement of Sponsor on a dMMR\u002FMSI status is mandatory to include the patient (the patient's file \\[an anonymized mail\\] must be send to Sponsor before inclusion). Approval\u002Frefusal email for inclusion of the patient will be sent by Sponsor within 24 hours of receipt of the Investigator email. In case of discrepancy between IHC and PCR, the final decision about the dMMR\u002FMSI status will be taken by Sponsor or coordinating investigator,\n7. Adequate hematological status, renal, and liver function obtained within 14 days prior to randomization of study treatment:\n\n   1. absolute neutrophil count (ANC) ≥1.5 x 10\\^9\u002FL; platelets ≥100 x 10\\^9\u002FL; hemoglobin ≥9 g\u002FdL,\n   2. serum creatinine level \\\u003C150 µM or clearance \\>50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault),\n   3. serum bilirubin ≤1.5 × upper limit of normal (ULN), alkaline phosphatase \\\u003C5 x ULN, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 x ULN,\n8. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 × ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic range is deemed appropriate by the Investigator,\n9. Has no contraindications to administration of oxaliplatin, capecitabine, or 5-fluorouracil, according to their respective summaries of product characteristics (SmPCs),\n10. Is able to undergo surgery and receive adjuvant treatment (chemotherapy) as part of standard care,\n11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n    1. Is a woman of non-childbearing potential as defined: i\u002F ≥45 years of age and has not had menses for \\>1 year, ii\u002F amenorrhea for \\\u003C2 years without a hysterectomy and oophorectomy and have a high follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, iii\u002F post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan,\n    2. Negative pregnancy blood test within 72 hours before the first dose of pembrolizumab, AND\n    3. If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception (Appendix 24.9) from screening throughout the study treatment and 4 months after the last dose of pembrolizumab,\n12. Male patient is eligible to participate if he agrees to the following during the study treatment and for 4 months after the last dose of pembrolizumab:\n\n    1. Refrain from donating sperm,\n    2. Must use contraception\u002Fbarrier as follows:\n\n       * Agree to use a male condom when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.\n       * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,\n13. Primary tumor tissue samples (archival or fresh biopsy specimen) acquired during coloscopy together with images availability (mandatory), NB: The patient's agreement will be specifically requested for endoscopic images in the patient information note and informed consent for their use as clinical data that may be analyzed and presented in publications. These data will be used in the same manner as other personal data. The confidentiality of these data will be maintained,\n14. Patient willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,\n15. Registeration in the National Health Care System (PUMa - Protection Universelle Maladie included).\n\nExclusion Criteria:\n\n1. Tumor that is not readily resectable,\n2. Bifocal colorectal adenocarcinoma,\n3. Locally advanced middle or low rectal cancer (\\\u003C10 cm from the anal verge on MRI, sagittal slide) staged as cT3\u002FT4 and\u002For N+ and\u002For with predictive circumferential margin \\>2 mm on pretreatment MRI, NB: for rectal cancers, the margin of the tumor relative to the anal margin should be indicated on the endoscopy report,\n4. Major surgical procedure within 4 weeks prior to the first dose of study treatment,\n5. Pre-existing hemostatic disorder or medical condition requiring chronic anticoagulation that cannot be interrupted for the purpose of study specified tumor resection or endoscopic biopsies,\n6. Metastases (stage IV disease),\n7. Has history of uncontrolled or symptomatic cardiac disease,\n8. Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents,\n9. Prior malignancy active within the previous 3 years apart from: i\u002F locally curable cancers that have been apparently cured (e.g., squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast); ii\u002F Lynch syndrome-related non-CRC in complete remission for \\> 1 year,\n10. Patient is human immunodeficiency virus (HIV)-positive with CD4+ cell count \\\u003C600 cell\u002Fml or detectable viral load,\n11. Has complete or partial dihydropyrimidine dehydrogenase deficiency (uracilemia ≥16 ng\u002Fml), In particular, the uracilemia level must be determined before patient inclusion. Patients with altered uracilemia will be excluded.\n12. Patient has active hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test) or hepatitis C virus (HCV) prior to inclusion, NB: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible. NB: Patients positive for HCV antibody are eligible only if PCR testing is negative for HCV RNA.\n13. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.\n14. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his\u002Fher consent,\n\n    Non-eligible to immunotherapy:\n15. Any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, NB: History of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n\n    NB: Controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.\n16. Prior (non-infectious) pneumonitis requiring systemic corticosteroid therapy or has currently pneumonitis,\n17. Any live, attenuated vaccine within 30 days prior to the first dose of study treatment or such administration is anticipated during the study,\n18. Prior allogeneic bone marrow transplantation or prior solid organ transplantation,\n19. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days (2 weeks) prior to the first dose of trial treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n20. Ongoing anti-cancer treatment for another cancer (to be discussed with the coordinator in case of hormone therapy in patients with prostate and breast cancer),\n21. Known hypersensitivity to any of the excipients of pembrolizumab, NB: L-histidine, L-Histidine Hydrochloride monohydrate, sucrose, polysorbate-80 (E433).\n\nNB: L-histidine, L-Histidine Hydrochloride monohydrate, sucrose, polysorbate-80 (E433).",{"count":223,"type":21},60,[24],"The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair \u002F high microsatellite instability (dMMR\u002FMSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR\u002FMSI-H localized CRC when treated with neoadjuvant pembrolizumab.\n\nEligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).",[227],"Colon Cancer",[229,230,231,232],"pembrolizumab","watch-and-wait","microsatellite instability","mismatch repair deficient","2025-06-12",{"date":235,"type":32},"2025-06-13",{"date":163,"type":21},{"date":165,"type":21},{"name":38,"class":39},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100498906","prognostic-and-predictive-markers-of-treatment-response-in-patients-with-pac-100498906","NCT05776342","Prognostic and Predictive Markers of Treatment Response in Patients With PAC.","Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma","CANOPE","Inclusion Criteria:\n\n* Patient with histologically confirmed pancreatic adenocarcinoma.\n* Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery\n* Diagnosis between January 1, 2003, and December 31, 2030.\n* First-line treatment with chemotherapy and\u002For radiotherapy and\u002For clinical trials.\n* Age ≥ 18 years.\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient under guardianship, curatorship, or judicial protection.\n* Pregnant or breastfeeding women.\n* Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.\n* Refusal to participate in the study",{"count":248,"type":21},4050,"The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.",[251],"Pancreatic Adenocarcinoma","2025-03-21",{"date":254,"type":32},"2025-03-25",{"date":256,"type":32},"2003-01-01",{"date":258,"type":21},"2031-12-31",{"name":38,"class":39},15,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100520663","phase-2-watch-and-wait-approach-with-dostarlimab-in-localized-dmmrmsi-h-gastric-cancer-gercor-phase-ii-study-100520663","NCT06059495","Watch-and-Wait Approach With Dostarlimab in Localized dMMR\u002FMSI-H Gastric Cancer: GERCOR Phase II Study","Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and\u002For Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study","DEWI","Inclusion Criteria:\n\n1. Capable of giving signed and dated informed consent,\n2. An ECOG PS of 0-1,\n3. ≥18 and ≤75 years old,\n\n   The patient over 75 years of age is eligible only if all the following conditions are met:\n   * The patient's G8 questionnaire score is above 14 AND\n   * The patient is eligible for surgery and has no contraindications to repeated UGI endoscopy with biopsies,\n4. Histologically proven non-metastatic gastric or OGJ adenocarcinoma cT2 to T4, Nx, M0 after computed tomography thorax-abdomen-pelvis (TAP-CT) and echo-endoscopy (EUS) according to the 7th Edition of the International Union Against Cancer; NB: Echo-endoscopy will be performed only if the tumor is not obstructive at UGI endoscopy ± a new UGI endoscopy with 10 biopsies, photos (if not done at the first UGI endoscopy done for diagnosis) and if possible (not mandatory) tumor tattooing\u002Finking. If obstructive, the tumor will be classified as cT3 or cT4 (in the situation when the tumor was obstructive and prevented EUS, it was classified T3N+, if it did not invade the adjacent organs on CT scan, because obstructing tumours represented locally advanced disease in the vast majority of cases in previous studies). In this case a new UGI endoscopy must be done with 10 biopsies, photos (if not done at the first GGI endoscopy done for diagnosis) and if possible (not mandatory) tumor tattooing\u002Finking to follow the location of the tumor.\n5. No peritoneal carcinomatosis (optional coelioscopy; recommended in case of doubt\u002F suspicious on CT\u002F imaging),\n6. No prior therapy (chemotherapy, radiotherapy, or immunotherapy) for localized gastric or OGJ adenocarcinoma,\n7. Tumor status confirmed to be dMMR\u002FMSI-H as follows:\n\n   \\- MMR protein expression status will be evaluated by immunohistochemistry (IHC) with four antibodies (anti-hMLH1, anti-hMSH2, anti-hMSH6, anti-hPMS2) according to the local procedures. dMMR will be defined as loss of MLSH1 and PMS2, loss of MSH2 and MSH6, or loss of only one protein with presence of MSI-H.\n\n   MSI analysis will be performed by polymerase chain reaction \\[PCR\\] using a pentaplex panel (BAT-25, BAT-26, NR-21, NR-24, and NR-27; PROMEGA). MSI-H is defined as instability in two or more of the five studied markers. For the purpose of this study samples with 2 unstable markers will also undergo MMR analysis by IHC. Agreement of Sponsor (GERCOR) on a dMMR\u002FMSI status is mandatory to include the patient (the patient's file \\[an anonymized mail\\] has to be send to Sponsor). Approval\u002Frefusal email for inclusion of the patient will be send by the Sponsor within 24 hours of receipt of the Investigator email. In case of discrepancy between IHC and PCR, the final decision about the dMMR\u002FMSI status will be taken by GERCOR or coordinating investigator,\n8. Hematological status: absolute neutrophil count (ANC) ≥1.5 x 109\u002FL; platelets ≥100 x 109\u002FL; hemoglobin ≥9 g\u002FdL,\n9. Adequate renal function: serum creatinine level ≤150 μM and clearance ≥50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault),\n10. Adequate liver function: ≤1.5 x upper limit of normal (ULN) of direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5 x ULN (inclusion possible if known Gilbert syndrome), alkaline phosphatase \\\u003C5 x ULN, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5 x ULN,\n11. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 x ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic range is deemed appropriate by the Investigator,\n12. Radiological tumor assessment at screening performed within 28 days before inclusion according to RECIST version 1.1 by chest, abdomen, and pelvis CT, showing the absence of metastatic or non-surgical disease,\n13. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n    * Is a woman of non-childbearing potential as defined: i\u002F ≥ 45 years of age and has not had menses for \\>1 year, ii\u002F Amenorrheic for \\\u003C2 years without a hysterectomy and oophorectomy and have a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, iii\u002F post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, magnetic resonance imaging (MRI), or CT scan. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must fulfill the criteria in Inclusion criteria 15. Information must be captured appropriately within the site's source documents,\n    * Negative pregnancy blood test within 72 hours before the first dose of dostarlimab, AND\n    * If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception from screening throughout the study treatment and 4 months after the last dose of dostarlimab,\n14. Male participants are eligible to participate if they agree to the following during the study treatment and for 4 months after the last dose of dostarlimab:\n\n    * Refrain from donating sperm,\n    * Must use contraception\u002Fbarrier as follows:\n\n      * Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.\n      * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,\n15. Providing primary tumor tissue samples (processed as formalin-fixed, paraffin-embedded \\[FFPE\\] blocks or freshly frozen) acquired during UGI endoscopy together with images (mandatory), NB: The patient's agreement will be specifically requested for endoscopic images in the patient information note and informed consent for their use as clinical data that may be analyzed and presented in publications. These data will be used in the same manner as other personal data. The confidentiality of these data will be maintained,\n16. Willingness and capablility to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,\n17. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included).\n\nExclusion Criteria:\n\n1. Prior concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),\n2. Treatment with any investigational medicinal product within 28 days prior to study entry,\n3. Treatment anticoagulant or hemostasis disorder contraindicating - biopsies during endoscopy,\n4. Major surgical procedure within 28 days (4 weeks) prior to the first dose of study treatment,\n5. Other serious and uncontrolled non-malignant disease (including active infection) or is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study,\n6. Other concomitant or previous malignancy other than the disease under study, except as noted below:\n\n   i\u002F adequately treated in-situ carcinoma of the uterine cervix, ii\u002F basal or squamous cell carcinoma of the skin, iii\u002F cancer from which the patients was in complete remission for ≥3 years,\n7. Metastases (M stage disease) whatever the location,\n8. Pregnancy or breastfeeding,\n9. Human immunodeficiency virus (HIV),\n10. Active hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test) or hepatitis C virus (HCV) prior to inclusion, Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible.\n\n    Note: Patients positive for HCV antibody are eligible only if PCR testing is negative for HCV RNA.\n11. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his\u002Fher consent,\n12. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.\n\nNon-eligible to immunotherapy:\n\n1. Pyloric tumor, NB: tumors of the pylorus will be excluded because of the risk of high occlusion in case of pseudo progression and associated surgery,\n2. Any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, Note: History of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n\n   Note: Controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.\n3. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest imaging,\n4. Any live, attenuated vaccine within 14 days prior to the firs dose of study treatment or such administration is anticipated during the study,\n5. Prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting CD137, CTLA-4, PD-1, or PD-L1 or other checkpoint pathways,\n6. Prior allogeneic bone marrow transplantation or prior solid organ transplantation,\n7. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\nNote: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of the Medical Contact. Note: Subjects are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses \\>10 mg daily prednisone is permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.","75 Years",{"count":271,"type":21},59,[24],"This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)\u002Fmicrosatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma.\n\nThe goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR\u002FMSI-H gastric\u002FOGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.",[275,276],"Adenocarcinoma - GEJ","Gastric Adenocarcinoma",[205,278,279,230,280,281],"MSI-H","dostarlimab","surgery","immunotherapy","2024-02-02",{"date":284,"type":32},"2024-02-05",{"date":286,"type":32},"2023-12-18",{"date":288,"type":21},"2028-09-01",{"name":38,"class":39},2,""]