[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut Paoli-Calmettes\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":581},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,40,68,92,120,140,160,179,201,222,240,262,289,310,337,358,387,408,429,449,468,492,515,537,557],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644194","metabolic-reprogramming-and-microenvironment-in-pancreatic-adenocarcinoma-100644194",false,"NCT07664891","Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma","Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma: Identification of New Therapeutic Targets","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Signed written informed consent specific to the PROMETAP study\n3. Affiliation with a social security system\n4. Treatment and follow-up performed at the Institut Paoli-Calmettes\n5. Metastatic PDAC requiring biopsy as part of routine care (group1 and 2)\n6. Prior treatment:\n\n   * No previous chemotherapy for the \"initial\" group\n   * No prior chemotherapy in the metastatic setting for the \"Metastatic Relapse\" group\n7. Eligible for chemotherapy (ECOG \\\u003C 2)\n\nNon-Inclusion Criteria:\n\n1. Contraindication to biopsy of the pancreatic tumor or a hepatic or pulmonary metastasis (group 1 and 2)\n2. Absence of a metastasis accessible to biopsy (group1 and 2)\n3. Concurrent treatment for another active cancer\n4. Pregnant or breastfeeding women\n5. Patients in emergency situations\n\n5\\. Adult individuals under legal protection (guardianship, trusteeship, judicial protection) or unable to provide informed consent","ALL","18 Years",{"count":20,"type":21},64,"ESTIMATED","6 Months","OBSERVATIONAL","The present project aims to elucidate the metabolic interactions within the tumor microenvironment of pancreatic adenocarcinoma, both in the primary tumor and in hepatic and pulmonary metastatic sites, as well as in circulating blood biomarkers.\n\nDeciphering these complex interactions aims to identify exploitable vulnerabilities for predicting treatment efficacy or for guiding therapeutic strategies.",[26],"Pancreatic Adenocarcinoma Metastatic","RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2025-09-11",{"date":35,"type":21},"2028-09-01",{"name":37,"class":38},"Institut Paoli-Calmettes","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":39},"100638439","immuno-lung--identification-of-biomarkers-and-therapeutic-targets-for-pulmonary-immunotherapy-100638439","NCT07608835","IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy","IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069","IMMUNOLUNG","Inclusion Criteria:\n\n* Patients aged 18 years or older, male or female.\n* Willing to participate in the study and having signed a written informed consent form.\n* Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.\n* Affiliated with a social security system or benefiting from such a system.\n\nExclusion Criteria:\n\n* Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.\n* Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.\n* History of solid organ transplantation or hematopoietic stem cell transplantation.\n* Pregnant or breastfeeding women.",{"count":49,"type":21},200,"INTERVENTIONAL",[52],"NA","Immunotherapy has helped improve the prognosis of metastatic lung cancer. However, only about 40% of patients respond to conventional immunotherapy with anti-PD(L)-1 agents. This research aims to identify biomarkers of response to immunotherapy at the tumor level and to characterize new therapeutic targets",[55],"Non-small Cell Lung Cancer",[57,58,59],"lung cancer","immunotherapie","progression free survival","2026-05-19",{"date":62,"type":31},"2026-05-27",{"date":64,"type":31},"2026-02-12",{"date":66,"type":21},"2033-05-12",{"name":37,"class":38},{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":50,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100637433","phase-2-fludarabine-treosulfan-reduced-intensity-conditioning-regimen-prior-haploidentical-stem-cell-transplantation-with-post-transplantation-cyclophosphamide-for-older-andor-frail-patients-with-aml-100637433","NCT07598110","FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND\u002FOR FRAIL PATIENTS WITH AML","FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND\u002FOR FRAIL PATIENTS WITH AML: FT-RIC-HAPLO-IPC 2025-016","FT-RIC-HAPLO","Inclusion Criteria:\n\n* Patient with age between 60 and 75 years old ; or aged 18-59 years if considered by the investigator for any reason as ineligible for MAC regimen (as defined by the EBMT criteria17), notably in case of HCT-CI ≥ 3 (patients planned by the investigators to receive a RIC regimen in clinical routine practice);\n* Patients with AML according to the ELN2022 classification criteria requiring allo-HSCT including the MDS\u002FAML sub category);\n* Less than 5% bone marrow blast at the time of inclusion (i.e. CR, CRi, CRh, or MLFS after prior treatment, according to ELN 2022);\n* Allo-HSCT planed with a haploidentical donor;\n* Covered by a Healthcare System;\n* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.\n\nExclusion Criteria:\n\n* Left ventricular function \\\u003C 40% ;\n* Renal clearance \\\u003C 50 mL\u002Fmin ;\n* Any severe uncontrolled medical condition considered by the investigator as a contraindication for using treosulfan;\n* Pregnant women or those who may become pregnant (without effective contraception) or breastfeeding;\n* Adults under legal protection (guardianship, curatorship, or judicial protection);\n* Inability to comply with the medical follow-up of the trial for geographical, social, or psychological reasons.","75 Years",{"count":78,"type":21},77,[80],"PHASE2","Acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS) predominantly affect older adults, and their incidence continues to rise with advanced age. For many patients, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative option capable of providing long-term disease control through the graft-versus-leukemia (GVL) effect. Historically, however, allo-HSCT was rarely offered to patients older than 50 years because of the high morbidity and mortality associated with myeloablative conditioning regimens and limited supportive care strategies. Over the past two decades, advances in reduced-intensity conditioning (RIC), infection prophylaxis, and donor availability have profoundly transformed the landscape, allowing increasing numbers of older patients to access transplantation.\n\nMultiple studies have demonstrated that allo-HSCT confers a survival benefit in older AML patients in complete remission compared with consolidation chemotherapy alone.\n\nThe intensity of conditioning profoundly influences both relapse risk and non-relapse mortality (NRM). myeloablative conditioning (NMAC) regimens are attractive for older adults due to their low toxicity but rely solely on the immunologic GVL effect and thus carry a higher relapse risk. Reduced-intensity conditioning (RIC) regimens, incorporating intermediate-dose alkylating agents such as busulfan, melphalan, or thiotepa, offer stronger anti-leukemic effect but at the cost of greater toxicity.\n\nThese observations underscore the central question: can a conditioning regimen combine strong anti-leukemic potency with the low toxicity required for older patients undergoing Haplo-SCT? The main objective is to evaluate the efficacy of FT-RIC regimen before Haplo-SCT for older and\u002For frail patients diagnosed with AML, who are not eligible for a myeloablative conditioning (MAC) regimen.\n\nTo achieve this objective, the investigators will assess Progression Free Survival (PFS) defined as the time from allo-HSCT to AML relapse or death.\n\nThis is a Multicenter trial, single arm prospective of phase II. Once the conditioning has been administered and the transplant performed, the patient will receive standard routine follow-up care, with the addition of questionnaires, and for patients followed at the Institut Paoli Calmettes only, blood samples will be collected.",[83],"Acute Myeloid Leukemia","NOT_YET_RECRUITING",{"date":86,"type":31},"2026-05-20",{"date":88,"type":21},"2026-10-10",{"date":90,"type":21},"2031-02-10",{"name":37,"class":38},{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":50,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100637776","a-trial-using-transcriptomic-signatures-to-personalize-neoadjuvant-chemotherapy-nac-for-patients-with-resectable-borderline-pancreatic-adenocarcinoma-pdac-100637776","NCT07592819","A Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)","A Multicenter Randomized Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)","PRODIGE 104 B","Inclusion Criteria:\n\n* Borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC) as defined by the National Comprehensive Cancer Network (NCCN) v2.2025 criteria, identified on contrast-enhanced CT scan and reviewed by a local multidisciplinary pancreatic expert board including at least a medical oncologist \u002F onco-gastroenterologist, a pancreatic surgeon, and an expert pancreatic radiologist. No central review required.\n* WHO Performance Status 0-1.\n* Histologically confirmed pancreatic ductal adenocarcinoma, including histological variants.\n* Patient included-but not randomized-in the PRODIGE 104 A NEOPREDICT study due to a negative gemcitabine sensitivity signature (GEM-).\n* Negative gemcitabine transcriptomic signature (test centrally performed in PRODIGE 104 A NEOPREDICT).\n* No prior chemotherapy or radiotherapy for pancreatic cancer, and no previous definitive pancreatic cancer resection (except one cycle of mFOLFIRINOX administered while awaiting the signature result).\n* Age \\> 18 years and \\\u003C 80 years, with the possibility to include patients aged 75-80 if a standardized geriatric assessment confirms eligibility for the study chemotherapy regimen.\n* Ability and willingness to comply with protocol requirements during the entire study period (treatment, scheduled visits, clinical and biological examinations, follow-up).\n* Patient's non-opposition to participation in the study.\n* Affiliation to the French national health insurance system.\n\nExclusion Criteria:\n\n* Strictly resectable or locally advanced PDAC according to NCCN criteria.\n* Distant metastases, including inter-aortocaval lymph nodes.\n* Any condition contraindicating the use of irinotecan, oxaliplatin, or 5-FU.\n* Complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Any uncontrolled or unstable medical condition within the past 6 months (e.g., hepatic, renal, respiratory, or cardiac insufficiency).\n* Another concomitant malignancy or history of cancer within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal\u002Fsquamous cell skin carcinoma.\n* Pregnancy or breastfeeding.\n* Patients under legal protection, guardianship, curatorship, or under judicial\u002Fadministrative protection.\n* Patients receiving psychiatric care or unable to provide consent.\n* Inability to comply with medical follow-up for geographical, social, or psychological reasons.","80 Years",{"count":102,"type":21},367,[52],"Pancreatic cancer exhibits significant heterogeneity, which poses a major challenge in selecting the best treatment for patients from the very beginning of care. Modern oncology recognizes the use of companion biomarkers to guide targeted therapy or immune checkpoint inhibitors. However, with regard to chemotherapy-which has long been the cornerstone of cancer treatment and remains crucial for most cancers-few predictive tests are available to guide the choice between monotherapy and combination chemotherapy.\n\nPatients included in the PRODIGE 104 B - NEOPREDICT study will be those for whom the GEM transcriptomic signature is negative. This population will be treated according to the standard strategy and will be followed clinically and biologically to describe and identify the characteristics specific to this subgroup, and to compare the usual prognostic factors of this population with those of the GEM-positive population included in the parallel PRODIGE 104 A - NEOPREDICT study",[106,107],"Pancreas Adenocarcinoma (MSI-H)","Pancreatic Cancer Resectable",[109,110,111],"Transcriptomic-guided chemotherapy","Borderline-resectable pancreatic cancer","Predictive biomarker validation","2026-05-11",{"date":114,"type":31},"2026-05-18",{"date":116,"type":21},"2026-05",{"date":118,"type":21},"2031-11",{"name":37,"class":38},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":50,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":139,"locationsCount":39},"100583911","post-immunotherapy-nephrectomy-for-metastatic-kidney-cancer-after-complete-or-major-response-to-systemic-therapy-100583911","NCT06882486","Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy","NAMECAR","Inclusion Criteria:\n\n1. Patient aged ≥ 18 years\n2. Diagnosed with synchronous metastatic kidney cancer\n3. With primary tumor still in place (no primary cytoreductive nephrectomy)\n4. Having received systemic ICI immunotherapy-based combination therapy\n5. In CR or mPR (defined as \\>75% response in metastatic lesions from baseline) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), excluding the primary renal lesion.\n6. Signed consent to participate\n7. Affiliated to the national social security scheme or beneficiaries of such a scheme\n\nExclusion Criteria:\n\n1. Women who are or may become pregnant (without effective contraception) or who are breast-feeding.\n2. Person in an emergency situation or unable to give consent.\n3. An adult under legal protection (guardianship, curators or safeguard of justice),\n4. Inability to undergo medical follow-up for geographical, social or psychological reasons.\n5. Patients who have undergone prior cytoreductive nephrectomy\n6. Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in metastatic disease\n7. Patients with non-metastatic disease at diagnosis who have received ICI in a neo-adjuvant setting\n8. Patients with contraindications to surgery or ineligible for nephrectomy\n9. Patients not wishing to undergo nephrectomy\n10. Patients with end-stage renal disease",{"count":128,"type":21},60,[52],"In the current era of immune checkpoint inhibitors (ICI), the role and timing of nephrectomy remains unknown, particularly in cases of residual kidney disease after a major response at metastatic sites. In these cases, the rationale for a delayed nephrectomy is that it might achieve a long-term response. This strategy could allow some patients to discontinue treatment and maintain tumor response. Furthermore, this approach might provide a potentially curative option for patients with metastases that are managed with and responding to ICI.\n\nRegarding the results of our first retrospective cohort data (showing that two thirds of patients are free from recurrence without systemic treatment after nephrectomy), we designed a non-comparative randomized phase II trial assessing progression-free survival of patients with complete response or major partial response after ICI-based treatment, operated on delayed nephrectomy with discontinuation of systemic therapy (experimental arm) and in patients managed with continuation of systemic therapy without nephrectomy (control arm).\n\nIn a de-escalation approach, this strategy may have sense to allow patients with an excellent response to immunotherapy to stop systemic treatment with a curative objective and a substantial impact from a medico-economic point of view.",[132],"Kidney Cancer","2026-03-18",{"date":135,"type":31},"2026-03-20",{"date":116,"type":21},{"date":138,"type":21},"2031-04",{"name":37,"class":38},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":50,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":39},"100558922","phase-2-de-escalation-study-evaluating-venetoclax-and-azacitidine-discontinuation-in-aml-responding-patients-100558922","NCT06557421","De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients","STOP VEN","Inclusion Criteria:\n\n1. Female\u002FMale ≥ 18 years of age;\n2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;\n3. VEN-AZA given as first-line treatment;\n4. Duration of VEN-AZA therapy of 12 months (+\u002F- 28 days), regardless of duration of VEN-AZA cycles and the doses;\n5. Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);\n6. Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD \\\u003C0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers \\\u003C0.1% in the blood);\n7. ECOG \\\u003C3;\n8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n9. Affiliated to the French Social Security or beneficiary of such a health Insurance;\n10. Signed informed consent.\n\nNon inclusion Criteria:\n\n1. VEN-AZA given as salvage therapy;\n2. Prior allogeneic stem cell transplant;\n3. Discontinuation of treatment because of absence or loss of response;\n4. Patient in emergency situation or unable to give consent;\n5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.",{"count":148,"type":21},50,[80],"The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:\n\n* Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.\n* Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.\n\nPatients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.\n\nParticipants will:\n\n* Stop VEN-DASA treatment\n* Be closely monitored by regular evaluation of the disease",[83],"2026-03-11",{"date":154,"type":31},"2026-03-13",{"date":156,"type":31},"2026-02-04",{"date":158,"type":21},"2028-11-01",{"name":37,"class":38},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":50,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":39},"100520365","phase-2-evaluation-of-dasatinib-monotherapy-efficacy-in-acute-myeloid-leukemia-patients-refractory-to-venetoclax-azacitidine-100520365","NCT06055621","Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE","Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE","VEN-R DASA","Inclusion Criteria:\n\n* Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)\n* Age ≥ 18 years\n* ECOG ≤3\n* VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration\n* Signed informed consent form\n* Affiliation to a social security system, or beneficiary of such a system\n\nExclusion Criteria:\n\n* Patient eligible to a targeted therapy having a market authorization\n* Central nervous system involvement\n* Heart failure\n* Liver failure\n* Kidney failure\n* Contraindication to DASATINIB\n* Positive for HIV (detectable viral load), Hepatitis B or C\n* Pregnant or breastfeeding woman\n* No efficient contraception for the women of childbearing age\n* Emergency situation person or not able to express his\u002Fher informed consent\n* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)\n* Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons",{"count":169,"type":21},35,[80],"The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.\n\nParticipants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.",[83],{"date":154,"type":31},{"date":175,"type":31},"2024-05-22",{"date":177,"type":21},"2027-10-31",{"name":37,"class":38},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":186,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":50,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100628400","reduction-of-hematologic-toxicity-in-locally-advanced-cervical-cancers-100628400","NCT07461142","Reduction of Hematologic Toxicity in Locally Advanced Cervical Cancers","RETHEMCOL","Inclusion Criteria:\n\n* Signed informed consent specific to the study.\n* Age ≥ 18 years. Patients aged over 70 must be screened using the G-8 geriatric assessment tool; if required (G-8 score ≤ 14), an onco-geriatric consultation is mandatory to confirm eligibility.\n* Histologically confirmed cervical cancer: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n* Locally advanced cervical cancer according to the FIGO 2018 classification, confirmed by clinical staging and\u002For imaging.\n* FIGO stage IB3 to IVA, for which definitive chemoradiotherapy with curative intent is planned.\n* No evidence of metastatic disease outside the para-aortic region at initial staging (clinical exam, pelvic MRI, FDG-PET, and\u002For para-aortic lymph node staging by laparoscopy if applicable).\n* Adequate hematologic and organ function, defined as laboratory results within 15 days prior to first study treatment:\n\nAbsolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ without G-CSF support Total white blood cells \\> 2,000\u002Fmm³ Lymphocytes ≥ 500\u002Fmm³ Platelet count ≥ 100,000\u002Fmm³ without transfusion Hemoglobin ≥ 9.0 g\u002FdL (transfusion allowed to meet this criterion)\n\n* Patients eligible to receive cisplatin or carboplatin-based concurrent chemotherapy, with or without prior carbo-taxol neoadjuvant chemotherapy (as discussed in the protocol comments).\n* Women of childbearing potential must have a negative pregnancy test (β-HCG) within 7 days before treatment and commit to highly effective contraception until 6 months after chemotherapy.\n\nExclusion Criteria:\n\n* Histologic types of cervical cancer other than those listed in the inclusion criteria.\n* FIGO IB1, IB2, or IIA stages without regional lymph node metastasis (N0).\n* FIGO IVB cervical cancer with distant metastases beyond para-aortic lymph nodes.\n* Previous surgery for cervical cancer, except conization or para-aortic lymphadenectomy.\n* Previous pelvic radiotherapy, other radiotherapy, or immunotherapy, except allowed neoadjuvant chemotherapy.\n* Any malignancy other than the study disease within the past 5 years, except non-melanoma skin cancers (BCC, SCC).\n* Pregnant or breastfeeding women, or women planning pregnancy during the study.\n* For patients ≥70 with G-8 ≤14: non-confirmation of eligibility by the onco-geriatrician.\n* Contraindication to cisplatin and\u002For carboplatin.\n* Peripheral neuropathy ≥ grade 2.\n* Systemic corticosteroids or systemic immunosuppressive drugs within 2 weeks before randomization (inhaled corticosteroids and mineralocorticoids such as fludrocortisone are allowed).\n* Untreated osteoporosis (T-score ≤ -3) diagnosed on bone densitometry performed within 6 months prior to inclusion.","FEMALE",{"count":188,"type":21},72,[52],"Cervical cancer is the fourth most common cancer among women and is mainly linked to infection with high-risk human papillomaviruses (HPV). Although most HPV infections resolve spontaneously, 570,000 women were diagnosed with cervical cancer in 2018, and more than half of them died from the disease.\n\nFor locally advanced disease, concurrent chemoradiotherapy (RT-CT) followed by brachytherapy is considered the standard therapeutic treatment. Even though progress has been made in chemotherapy, external beam radiotherapy, and brachytherapy over the past decades-on the one hand by reducing the duration of chemotherapy-induced cytotoxicity, and on the other hand by decreasing radiation doses delivered to organs at risk-hematologic toxicity following concurrent chemoradiotherapy remains a frequent complication.\n\nThe indication and benefit of chemotherapy have been demonstrated in phase III clinical trials; however, grade 3 hematologic toxicity (anemia, leukopenia, and thrombocytopenia) remains between 18.7% and 21.3%. Since total treatment duration is a prognostic factor for local control, brachytherapy must be administered near the end of or immediately after RT-CT so that total treatment time is as short as possible (≤ 50 days). If grade 3 hematologic toxicity persists after RT-CT (prior to brachytherapy), brachytherapy will be delayed, leading to a loss of disease control (Tanderup et al., 2016).\n\nDose reduction to the bone marrow is possible, but to date no randomized trial has evaluated it. The objective of this multicenter French study is to assess whether bone-sparing-contouring of the pelvic and\u002For lumbosacral osseous structures as an organ at risk (OAR) during external radiotherapy planning-reduces the incidence of grade ≥ 3 hematologic toxicity and the use of leukocyte growth factors, platelet transfusions, and\u002For blood transfusions, while adhering to current recommendations and without compromising clinical outcomes in patients treated with RT-CT and brachytherapy for locally advanced cervical cancer.",[192],"Cervical Cancer by FIGO Stage 2018","2026-03-04",{"date":195,"type":31},"2026-03-10",{"date":197,"type":21},"2026-07-15",{"date":199,"type":21},"2031-08-30",{"name":37,"class":38},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":186,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":39},"100401246","real-time-molecular-analysis-of-breast-cancer-receiving-neo-adjuvant-chemotherapy-100401246","NCT04504747","Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy","Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance","NEO-R","Inclusion Criteria:\n\n1. Woman over 18\n2. Signed consent to participate\n3. Invasive mammary adenocarcinoma proven histologically and \u002F or cytologically\n4. Indication of CNA retention by the referring clinical team.\n5. No contraindication to CNA.\n6. Selected indication of the post-CNA surgery sequence, then radiotherapy\n7. Performance index ≤ 1 (WHO).\n8. Affiliation to a social security scheme, or beneficiary of such a scheme\n\nExclusion Criteria:\n\n1. Planned therapeutic sequence: CNA, followed by neoadjuvant radiotherapy (HIST-RIC clinical trial for example) before surgery\n2. Metastatic disease at diagnosis\n3. Patient relapsed from breast cancer precede\n4. Other malignant disease in the previous 3 years, with the exception of cervical carcinoma in situ or skin basal cell carcinoma and any other cancerous pathology considered to have been properly treated and at low risk of relapse.\n5. Woman pregnant or likely to be (without effective contraception) or breastfeeding\n6. Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent.\n7. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons",{"count":210,"type":21},150,"The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the molecular analyses of biopsies sampled before and after NAC, from in vitro BC Patient-Derived Organoids (PDO) mimicking patient's response to NAC, and from Circulating Tumor Cells (CTCs) isolated before\u002Fduring\u002Fafter NAC.",[213],"Breast Cancer Female","2025-06-13",{"date":216,"type":31},"2025-06-15",{"date":218,"type":31},"2022-11-03",{"date":220,"type":21},"2030-01",{"name":37,"class":38},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":50,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":39},"100376726","butyrophilins-role-in-colon-cancer-100376726","NCT04185272","Butyrophilins Role in Colon Cancer","Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation","Inclusion Criteria:\n\n* Patient is older than 18 years old,\n* Signed participation consent,\n* Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.\n* Performance Status (PS) 0 or 1\n* affiliated to the social security or beneficiary\n\nExclusion Criteria:\n\n* Rectal cancer, colon cancer recurrence\n* Emergency of colon cancer Surgery\n* History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)\n* Patient who received neoadjuvant therapy other than chemotherapy\n* Patient treated with immune-suppressors or long-course corticosteroids \\\u003C12 months\n* Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding,\n* Person in urgent situation, person under legal protection measure, or unable to express his \u002F her consent,\n* Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons",{"count":49,"type":21},[52],"quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer",[233],"Colonic Cancer",{"date":216,"type":31},{"date":236,"type":31},"2020-06-30",{"date":238,"type":21},"2028-06",{"name":37,"class":38},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":50,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":39},"100519687","efficacy-of-first-line-gemcitabine-chemotherapy-in-gemcore-metastatic-pancreatic-adenocarcinoma-patients-100519687","NCT06046794","Efficacy of First-Line Gemcitabine Chemotherapy in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients","Phase IV Study Assessing Efficacy of First-Line Chemotherapy With Gemcitabine in GemCore+ Metastatic Pancreatic Adenocarcinoma Patients Ineligible to FOLFIRINOX Treatment","GemSign-01","Inclusion Criteria:\n\n* Metastatic pancreatic adenocarcinoma histological proved\n* FOLFIRINOX chemotherapy-ineligible patient and going to receive first-line metastatic chemotherapy with gemcitabine monotherapy\n* Tumor material allowing assessment of GEMCore status (i.e. FFPE block with tumor cellularity ≥ 10%);\n* Life expectancy \\> 2 months;\n* Measurable target according to RECIST 1.1 criteria;\n* No previous treatment in metastatic situation;\n* Age ≥ 18 years;\n* Patient not opposed to study participation;\n* Affiliation to a social security system, or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Contraindication to Gemcitabine treatment;\n* ECOG performance status ≥ 3;\n* Person in emergency situation or unable to express non-opposition;\n* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice);\n* Unable to undergo medical follow-up for geographical, social or psychological reasons.",{"count":249,"type":21},100,[52],"The goal of this interventional study is to learn about the efficacy of first-line chemotherapy with Gemcitabine in metastatic pancreatic adenocarcinoma patients expressing the GemCore signature in their tumor. The main question it aims to answer is to assess efficacy of Gemcitabine (tumor response, survival rate) in the population of patient bearing the GemCore signature.\n\nParticipants will start the chemotherapy with Gemcitabine as usually performed in standard care of their center. They will consent to a genomic analyze of their tumor to know if it bears the GemCore signature. The center will manage the participant's follow up as usually realized in standard care.",[253],"Cancer Of Pancreas","2025-06-10",{"date":256,"type":31},"2025-06-11",{"date":258,"type":31},"2024-05-23",{"date":260,"type":21},"2027-11-01",{"name":37,"class":38},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":270,"targetDuration":4,"studyType":50,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":39},"100402489","pancreatic-radiofrequency-under-high-echo-endoscopy-in-the-management-of-pancreatic-neuroendocrine-tumors-100402489","NCT04520932","Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors","Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size","RFANET","Inclusion Criteria:\n\n* Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI;\n* Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\\\u003C3%,\n* Non-secretory lesion.\n* Homogeneous HEE contrast taking;\n* No positron emission tomography (PET) FDG binding to the pancreatic mass;\n* Lesion \\\u003C20mm on conventional imaging at 6 months monitoring;\n* Age 18 to 80 years inclusive;\n* Patient in good general condition, World Health Organization \\[0-1\\];\n* Signed consent to participate;\n* Affiliation to healthcare insurance system or beneficiary of this regimen.\n\nExclusion Criteria:\n\n* Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;\n* A person in an emergency situation or deprived of liberty or placed under the authority of a tutor.\n* Life expectancy \\\u003C 1 year;\n* Severe hemostasis disorders;\n* Pancreatic and\u002For biliary ductal dilation;\n* Lesion considered to be adjacent to the pancreatic duct and\u002For bile duct;\n* Node extension and\u002For metastatic disease;\n* Patient being managed for another malignant lesion which is progressive or under treatment.",{"count":271,"type":21},82,[52],"Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.",[275,276],"Neuroendocrine Tumor of Pancreas (Disorder)","Neuroendocrine Tumor Grade 1",[278,279,280,281],"Radio Frequency treatment","Echoendoscopy","Ablation","Efficacy","2025-05-23",{"date":284,"type":31},"2025-05-25",{"date":286,"type":31},"2021-03-30",{"date":138,"type":21},{"name":37,"class":38},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":39},"100584801","study-of-radiology-manipulator-work-validation-by-the-radiologist-100584801","NCT06894082","Study of Radiology Manipulator Work Validation by the Radiologist","COOPERATION BETWEEN THE MEDICAL ELECTRORADIOLOGY MANIPULATOR (MEM) AND THE RADIOLOGIST IN TUMOR IMAGING ASSESSMENTS: CIMER-IPC 2023-030","Cimer","Inclusion Criteria:\n\n* Male or female aged 18 and over\n* Patient included in a clinical research protocol in oncology for solid cancer including RECIST 1.1 interpretation\n* Disease measurable according to RECIST 1.1\n* Patient not objecting to study participation\n* Member of a social security scheme, or beneficiary of such a scheme.\n\nNon inclusion Criteria:\n\n* Patients with lymphoma or leukemia\n* Patient contraindicated to iodinated contrast media injection\n* Person in an emergency situation, adult subject to a legal protection measure (major under guardianship, curatorship or safeguard of justice), or unable to express, his\u002Fher non-opposition to participate in the study\n* Unable to undergo medical follow-up for geographical, social or psychological reasons.\n\nor psychological reasons.\n\nExclusion Criteria:\n\n* Patient with renal insufficiency or allergy during the trial no longer allowing injection of iodinated contrast medium\n* Patient refusing iodinated PDC injection during the study\n* Patient withdrawn from the study including scanner interpretation in Recist 1.1",{"count":298,"type":21},87,"The main objective of this study is to evaluate the pre-filling work on target and non-target lesions, and the detection of any new lesions reported by the MEM trained in protocol evaluations, in a structured table to prepare the radiologist's work in interpreting RECIST 1.1 scans.\n\nTo meet this objective, patients taking part in the CIMER study will first have been included in a research protocol requiring scans with RECIST 1.1 interpretation.\n\nThe Baseline examination will be performed and interpreted according to RECIST 1.1 without informing the radiologist performing the reading that the patient is included in the study, so as not to introduce an interpretation bias.\n\nDuring the first evaluation. The investigating MEM alone will carry out a preliminary analysis of the first evaluation and will present his results to the radiologist in charge of the evaluation, who will validate the conformity of the results.",[301],"Solid Cancer","2025-03-18",{"date":304,"type":31},"2025-03-25",{"date":306,"type":31},"2024-12-12",{"date":308,"type":21},"2027-05",{"name":37,"class":38},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":50,"phases":320,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":39},"100360795","evaluation-of-the-use-of-a-biodegradable-endoprothesis-in-the-prevention-of-post-endoscopic-retrograde-choloangiopancreatography-pancreatitis-100360795","NCT03977779","Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis","Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis","ARCHIMEDE","Inclusion Criteria:\n\n* Age\\>18 years\n* Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and\u002For patient-related risk factors\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Recent diagnosis (\\\u003C1 month) of acute pancreatitis\n* contraindication to endoscopy\n* Hypersensitivity to indomethacine",{"count":319,"type":21},46,[52],"The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.",[323,324,325],"Obstructive Jaundice","Biliary Stricture","Sphincter of Oddi Dysfunction",[327,328],"biodegradable stent","Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis","2024-10-23",{"date":331,"type":31},"2024-10-24",{"date":333,"type":31},"2022-01-20",{"date":335,"type":21},"2024-12-15",{"name":37,"class":38},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":346,"studyType":23,"phases":4,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":39},"100512649","test-of-cd47-sirp-inhibitors-on-the-immune-microenvironment-colon-cancer-100512649","NCT05955196","Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer","MACROSWITCH","Inclusion Criteria:\n\n* Patient over 18 years old\n* Patient who has signed a consent to participate;\n* Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;\n* Patient affiliated to a social security scheme, or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patient who had emergency colon cancer surgery\n* Person in an emergency situation or unable to express their consent.\n* Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),\n* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons",{"count":345,"type":21},115,"24 Months","Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .\n\nIn order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.",[349],"Cancer of the Colon","2024-10-08",{"date":352,"type":31},"2024-10-09",{"date":354,"type":31},"2023-01-09",{"date":356,"type":21},"2027-01-09",{"name":37,"class":38},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":186,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":50,"phases":368,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":39},"100515020","phase-1-iii-phase-study-evaluating-m1774-in-combination-with-fulvestrant-in-hr-and-her2--advanced-breast-cancers-100515020","NCT05986071","I\u002FII Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers","A Phase I\u002FII Study Evaluating M1774, an ATR Inhibitor, in Combination With Fulvestrant in Hormone Receptor-positive and HER2-negative, Advanced Breast Cancers, Resistant to CDK4\u002F6 Inhibitor Plus Aromatase Inhibitor-based Endocrine Treatment","MATRIX","Inclusion Criteria:\n\n1. Age ≥ 18 years of age (or \\> 18, depending on countries' legal age of majority) at the time of signing the informed consent.\n2. Man or postmenopausal woman due to either surgical\u002Fnatural menopause or chemical ovarian suppression (maintained during all the study treatment) with a gonadotropin-releasing hormone (GnRH) agonist or radiation-induced ovarian suppression.\n3. Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.\n4. Patient has pathologically confirmed hormone receptors (HR)-positive (ER+ and\u002For PgR+) and HER2-negative advanced BC by local laboratory on the last tissue examined. HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing\n5. Patient has disease progression while receiving aromatase inhibitor therapy (i.e. letrozole, anastrozole, exemestane) in combination with CDK4\u002F6 inhibitors (palbociclib, ribociclib, abemaciclib) administered in the advanced setting or patients has recurrence while receiving aromatase inhibitor therapy (i.e. letrozole, anastrozole, exemestane) in combination with CDK4\u002F6 inhibitors (palbociclib, ribociclib, abemaciclib) or within 12 months of the end of CDK4\u002F6 inhibitors when administered in the early setting.\n6. For phase 2 part only : patient whose tumor displays (according to local tumor boards) either\n\n   * Germline or somatic BRCA1, BRCA2 or PALB2 mutations and prior exposure and resistance to PARP inhibitors (cohort 1).\n   * Documented deleterious germline or somatic alterations associated with HRD : BARD1 BRIP1, CDK12, CHEK2, FANCA, FANCD2, FANCL, MRE11A, NBN, PPP2R2A, RAD51B, RAD51C, RAD51D and RAD54L (cohort 2). Patients with sBRCA1, sBRCA2 and g\u002FsPALB2, without previous exposure to PARP inhibitors, may be enrolled in this cohort.\n   * Oncogenic driver amplification (such as MYC, RAS, Cycin E1) or mutations of the following genes: ATM, ARID1A, ERCC4, XRCC1, RB1, ATRX, DAXX, suspected to favor RS and thereby sensitivity to ATR inhibitors as determined by a local molecular tumor board and validated by the central molecular tumor board (cohort 3).\n7. Tumor site accessible for baseline biopsy or archival tissue available without any specific anticancer treatment after collection\n8. No more than one previous chemotherapy regimen for advanced disease (including antibody drug conjugates) ; (neo)adjuvant chemotherapy is allowed\n9. No more than 1 previous endocrine therapy administered for metastatic disease\n10. Patient with gBRCA1\u002F2 must have received PARP inhibitors and have experienced disease progression during or after treatment\n11. Patient has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n12. Patient must have normal organ and marrow function\n\n    Adequate hematologic function as indicated by:\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Absolute neutrophil count \\> 1,500\u002FµL with no growth factor treatment within the last 14 days\n    * Hemoglobin ≥ 10.0 g\u002FdL, with no erythropoietin or red blood cell transfusion within the last 14 days.\n\n    Adequate hepatic function as indicated by:\n    * Total bilirubin ≤ 1.5 × ULN. In the case of documented Gilbert's syndrome, total bilirubin ≤ 2.0 × ULN is allowed.\n    * AST and ALT levels ≤ 3 × ULN or ≤ 5 × ULN in presence of liver metastases.\n13. Adequate renal function defined as: serum creatinine ≤ 1.5 × ULN. If serum creatinine is \\> 1.5 × ULN, creatinine clearance needs to be ≥ 60 mL\u002Fmin by calculation using the Cockcroft-Gault formula or by measured 24-hour urine collection. The Cockcroft-Gault formula is (glomerular filtration rate \\[mL\u002Fmin\\] = {(l40-age) × weight\u002F(72 × serum creatinine \\[mg\u002FdL\\])} × 0.85 \\[if female\\]).\n14. A female participant must have a negative serum pregnancy test, as required by local regulations, before the first dose of study intervention).\n\n    Contraceptive use will be consistent with local regulations on contraception methods for those participating in clinical studies.\n\n    Female participants of childbearing potential will be using highly effective contraception for throughout the study and for at least 6 months after last M1774 treatment administration. Women should not breastfeed during the study and for at least 1 month after the study period, (i.e., after the last dose of study intervention is administered).\n\n    Male participants will be using highly effective contraception for throughout the study and for at least 3 months after last M1774 treatment administration.\n15. Patient has measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria\n16. Patient affiliated to the national \"Social Security\" regimen or beneficiary of this regimen or any other regimen of social security\n17. Are capable of giving signed informed consent(or a trusted person) , which includes compliance with the requirements and restrictions listed in the ICF and this protocol.\n\nExclusion Criteria:\n\n1. Has received previous fulvestrant\n2. Any investigational therapy within ≤ 21 days or 5 half-lives prior treatment, whichever is longer, prior treatment\n3. Any hormonal therapy within 7 days prior treatment (except ovarian function suppression).\n4. Any cytotoxic therapy within 21 days (3-weekly regimen), 14 days (weekly or oral regimen) prior treatment\n5. Previous treatment with ATR or CHK1 inhibitors (unless treatment was for less than 3 weeks duration and at least 12 months have elapsed between the last dose and randomization. Patients that did not tolerate prior treatment are excluded). Prior treatment with PARP inhibitor is allowed\n6. . .\n7. Patients with second primary cancer, EXCEPTIONS: adequately treated non melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years prior to study entry (including lymphomas \\[without bone marrow involvement\\]).\n8. Mean resting corrected QTc interval using the Fridericia formula (QTcF) = \\>470 msec\u002Ffemale patients and \\>450 msec for male patients obtained from 3 ECGs Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification ≥ Class III), uncontrolled cardiac arrhythmia, calculated QTc average using the QTcF \\> 470 msec; unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start.\n9. Any of the following cardiac diseases currently or within the last 6 months\n10. Unstable angina pectoris\n11. Congestive heart failure ≥ Class 2 as defined by the New York Heart Association\n12. Acute myocardial infarction\n13. Conduction abnormality not controlled with pacemaker or medication (patients with a conduction abnormality controlled with pacemaker or medication at the time of screening are eligible)\n14. Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)\n15. Other clinically significant heart disease\n16. Concomitant use of known strong cytochrome P (CYP) 3A inhibitors (eg itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem,fluconazole, verapamil).\n17. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil).\n18. Persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy.\n19. Major surgery within 2 weeks of starting study treatment: patients must have recovered from any effects of any major surgery.\n20. Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n21. Patients with known active hepatitis (ie, hepatitis B or C).\n22. Visceral crisis or impending visceral crisis at time of screening.\n23. CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement).\n24. uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition.\n25. Active infection requiring antibiotics at day 1 of cycle 1\n26. Active and\u002For uncontrolled infection. The following exceptions apply:\n\n    * Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction.\n    * Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels \\\u003C ULN, and provided there is no expected drug-drug interaction.\n    * Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels \\\u003C ULN.\n27. Participants with clinically controlled brain metastases, which is defined as individuals with central nervous system metastases that have been treated for, are asymptomatic, and have discontinued corticosteroids for \\> 14 days or are on a stable or decreasing steroid dose (for the treatment of brain metastases) may be enrolled. Participants with meningeal carcinomatosis are excluded.\n28. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease (SD) for 28 days.\n29. Patients with a history of treated central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: Disease outside the CNS is present. No clinical evidence of progression since completion of CNS-directed therapy. Minimum of 3 weeks between completion of radiotherapy and Cycle 1 Day 1 and recovery from significant (Grade ≥3) acute toxicity with no ongoing requirement for \\>10 mg of prednisone per day or an equivalent dose of other corticosteroid. If on corticosteroids, the patient should be receiving a stable dose of corticosteroids, started at least 4 weeks prior to treatment\n30. Any other clinical condition, uncontrolled concurrent illness, or other situations, which in the Investigator's opinion would not make the patient a good candidate for the study or may potentially impact the absorption of M1774 such as (but not limited to) significant small bowel resection, gastric surgery, or exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy.\n31. Live vaccines within 4 weeks of first dose of study intervention and while receiving study intervention. Administration of inactivated vaccines (i.e., inactivated influenza vaccine) is permitted. Inactivated RNA or nonreplicating viral vector-based SARS-CoV-2 vaccines are allowed, as approved by local\u002Fregional Health Authorities. Novel live attenuated SARS CoV-2 vaccines are not permitted.\n32. Persistence of AEs related to any prior treatments that have not recovered to Grade ≤ 1 unless AEs are clinically non significant (e.g. alopecia) and \u002For stable on supportive therapy in the opinion of the Investigator.\n33. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n34. History or known hypersensitivity to the active substances or to any excipients of the study interventions.\n35. Pregnant or breast feeding women.\n36. Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up",{"count":367,"type":21},57,[369,80],"PHASE1","CDK4\u002F6 inhibitor in combination with endocrine treatment is the standard of care in advanced breast cancer (ABC) with expression of hormone receptors and without HER2 overexpression (ER+\u002FHER2-). When patients experience disease progression under this strategy, options of second-line endocrine treatment in combination with other targeted therapies are limited and have failed to improve overall survival to date over endocrine treatment alone. A significant fraction of ER+\u002FHER2- ABC display genetic alterations associated with homologous recombination deficiency (HRD) which may be associated with efficacy of therapeutic targeting DNA damage response (DDR) pathways. Moreover, other molecular alterations associated with replicative stress may be found in ER+\u002FHER2- ABC patients which may also favor antitumor activity of DDR targeting therapeutics. M1774 is a novel orally administered inhibitor of ataxia telangiectasia and rad3-related (ATR), a protein kinase with key activity in DDR pathway. MATRIx is a phase I\u002FII study aiming to determine the recommended phase II dose (RP2D, phase I) as well as efficacy and safety (phase II) of M1774 in combination with fulvestrant in ER+\u002FHER2-ABC patients whose disease has become resistant to aromatase inhibitor plus CDK4\u002F6 inhibitor, and whose tumor displays molecular alterations associated with HRD, oncogenic driver activation and\u002For replicative stress. Primary endpoints will include: maximum tolerated dose (MTD) of M1774 in combination with fulvestrant (phase I), the clinical benefit rate and toxicity of the combination at RP2D of M1774 in the molecularly selected population (phase II). Baseline, on-treatment and post-treatment blood and tumor tissue samples will be collected for pharmacokinetics and translational analyses including genomic characterization of tumor tissue and ctDNA as well as functional studies focusing on DDR pathways.",[372],"Breast Cancer",[374,375,376,377,378],"M1774","fulvestrant","CDK4\u002F6","breast cancer","homologous recombination deficiency","2024-03-27",{"date":381,"type":31},"2024-03-29",{"date":383,"type":21},"2024-05-01",{"date":385,"type":21},"2027-10-15",{"name":37,"class":38},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":50,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":4},"100516133","early-detection-of-pancreatic-cancer-in-patients-with-papillary-and-mucinous-intracanal-tumours-of-the-pancreas-papillary-and-mucinous-tumours-of-the-pancreas-100516133","NCT06000553","Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas","Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas PCS-IPMN-IPC 2023-005","Inclusion Criteria:\n\n1. Age over 18\n2. Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)\n3. Signed consent to participate\n4. Affiliation with a social security scheme, or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding woman\n2. Person in an emergency situation or unable to give consent.\n3. Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),\n4. Unable to undergo medical follow-up for geographical, social or psychological reasons.\n5. contraindication to MRI.",{"count":395,"type":21},360,[52],"This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.",[399],"PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS","2023-08-17",{"date":402,"type":31},"2023-08-21",{"date":404,"type":21},"2023-10-30",{"date":406,"type":21},"2028-10-30",{"name":37,"class":38},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":50,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":4},"100500917","pancreatic-cancer-dynamic-assessment-at-all-stages-of-treatment-100500917","NCT05802485","PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT","PANCREATIC CANCER: DYNAMIC ASSESSMENT AT ALL STAGES OF TREATMENT: PANDORE-PANC-IPC 2021-082","Inclusion Criteria:\n\n* Non-metastatic pancreatic adenocarcinoma that is not immediately resectable (borderline and locally advanced tumors according to the NCCN 2020 classification)\n* No previous treatment with surgery or chemotherapy\n* Age \\> 18 years\n* General condition WHO 0-2 (patient whose general condition can allow medical treatment or surgery)\n* Therapeutic management at the Paoli-Calmettes Institute\n* Signature of the informed consent specific to the PANDORE-PANC study\n* Patient affiliated to a social security system or benefiting from such a system\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pancreatic tumor of a histological type other than adenocarcinoma\n* Other tumor under treatment or for which treatments have been completed for \\\u003C 1 year\n* Pregnant or breastfeeding women\n* Person in an emergency situation\n* Person of legal age under legal protection (guardianship, curatorship or safeguard of justice) or unable to give consent.",{"count":416,"type":21},300,[52],"The study consists of a 25 ml blood sample collection:\n\n* Before the start of treatment\n* Approximately 2 months after the start of induction chemotherapy\n* At the end of induction chemotherapy\n* Prior to local treatment (radiotherapy, surgery)\n* At the time of tumor progression\n\nCollection of tumor material:\n\n* During the initial diagnostic biopsy\n* On the operating room in case of surgery\n* At tumor biopsy in case of recurrence or progression (optional) As well as the completion of a questionnaire at inclusion.",[420],"Pancreatic Cancer Non-resectable","2023-03-27",{"date":423,"type":31},"2023-04-06",{"date":425,"type":21},"2023-04-30",{"date":427,"type":21},"2029-02-01",{"name":37,"class":38},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":50,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":4},"100485522","collection-of-sequential-samples-from-patients-with-malignant-myeloid-hemopathy-for-the-study-of-treatment-resistance-100485522","NCT05602168","Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance","Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061","Inclusion Criteria:\n\n1. Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,\n2. Patient for whom a new line of therapy is initiated.\n3. Patient older than 18 years of age.\n4. Patient affiliated to the social security system or benefiting from such a system.\n5. Signed consent to participate.\n\nExclusion Criteria:\n\n1. Weight at inclusion \\\u003C 50 kg\n2. Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient\n3. Person in an emergency situation, adult under legal protection (guardianship, curatorship, etc.) protection (guardianship, curatorship or safeguard of justice), or unable to express his or her consent.\n4. Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,\n5. Pregnant or breastfeeding women",{"count":437,"type":21},400,[52],"The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.",[441],"Hematologic Cancer","2022-10-26",{"date":444,"type":31},"2022-11-01",{"date":446,"type":21},"2023-01",{"date":220,"type":21},{"name":37,"class":38},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":50,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":4},"100479183","phase-1-a-phase-1b2-trial-evaluating-safety-and-efficacy-of-capecitabine-in-combination-with-ni-raparib-in-her2-negative-advanced-breast-cancer-100479183","NCT05519670","A Phase 1b\u002F2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr","CAPRICE","Inclusion Criteria:\n\n1. Women or men aged 18 or more\n2. Histologically-confirmed advanced breast cancer (metastatic or locally advanced)\n3. Tumor without overexpression of HER2 (HER2 1+ in IHC, or IHC 2+ and FISH\u002F CISH negative) in samples from the primary and\u002For secondary tumor\n4. Hormone receptor status known\n5. Endocrine insensitive (hormone receptor negative or Endocrine (aromatase inhibitor)-resistant (a CDK4\u002F6-based endocrine treatment must have been administered as a first-line of second-line treatment, unless primary endocrine-refractory disease as defined as relapse within the first 2 years of aromatase-based adjuvant endocrine therapy or progression under endocrine treatment administered for metastatic disease within 6 months of initiation))\n6. Progressive disease patients who are eligible to a treatment with capecitabine: after fail-ure to taxanes and anthracycline-based chemotherapy (unless contraindicated) (neoadjuvant, adjuvant or metastatic setting)\n7. A representative tumor specimen must be available for molecular testing. An archival tu-mor sample may be submitted (\\\u003C6 months); however, if one is not available, a newly obtained tumor biopsy specimen must be submitted instead\n8. Measurable disease according to RECIST1.1\n9. Symptomatic, untreated, or actively progressing central nervous system (CNS) metasta-ses are not eligible. Patients with a history of treated CNS lesions are eligible, provided all of the following criteria are met:\n\n   1. Measurable or non-measurable disease, per RECIST v. 1.1, must be present outside the CNS\n   2. No history of intracranial haemorrhage or spinal cord haemorrhage\n   3. Metastases are limited to the cerebellum or the supratentorial region (i.e., no metasta-ses to the midbrain, pons, medulla, or spinal cord).\n   4. There is no evidence of interim progression between completion of CNS-directed ther-apy and the screening brain scan.\n   5. The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.\n   6. The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.\n\nAsymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan.\n\n10\\. Patients must have an estimated survival of at least 3 months 11. WHO performance status (ECOG) from 0 to 1 12. Adequate hematological and coagulation function: Hb ≥ 10.0 g\u002FdL, ANC ≥ 1500\u002Fmm3 platelets ≥ 150 000\u002Fmm3, INR ≤ 1.5 13. Adequate hepatic function : total serum bilirubin ≤ 1x ULN, or total bilirubin ≤ 2.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome, ALAT and ASAT ≤ 1.5 x ULN 14. Adequate renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL\u002Fmin 15. Adequate ionic balance: potassium, calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution 16. Participant must have normal blood pressure or adequately treated and controlled hyperten-sion17. A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n* Is not a woman of childbearing potential (WOCBP) OR\n* Is a WOCBP and must agree to use a highly effective contraceptive method (described in 6.6.2) while on treatment and for at least 180 days after study drugs discontinuation.\n\n  18\\. A WOCBP must have a negative pregnancy test (highly sensitive urine test or serum test as required by local regulations) within 72 hours before the first dose of study treatment.\n\n  19\\. Male participants are eligible to participate if they agree to the following during the interven-tion period and for at least 90 days after the last dose of study treatment:\n* Refrain from donating sperm\n* Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) 20. Patient must be affiliated to a Social Security system 21. Patient information and written informed consent form signed 22. Must be able to swallow and retain orally administered study treatment. 23. For expansion cohort: inclusion will be done regarding availability of homologous recom-bination status\n\nExclusion Criteria:\n\n1. Prior treatment with a PARP inhibitor and capecitabine for metastatic disease, (Patients treat-ed with these drugs in the adjuvant setting are allowed to participate if they experienced 2 years from end of treatment and metastatic relapse)\n2. Patient has a Dihydropyrimidine dehydrogenase deficiency (DPD)\n3. Patients must not have received anticancer chemotherapy, targeted therapy within 2 weeks prior of the study. Endocrine therapy must have been discontinued 7 or more days before Cycle 1 Day 1. Participant must not have had investigational therapy administered within 4 weeks or with-in a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.\n4. Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. Biphosphonates and denosumab are allowed.\n5. Major surgery within 3 weeks prior to registration. Patients must have recovered from earlier major surgery before registration.\n6. Persistent toxicities (≥NCI-CTCAE grade 2) caused by previous cancer therapy, excluding alopecia and NCI-CTCAE grade 2 peripheral neuropathy.\n7. Immunocompromised patients (e.g. HIV) for part I and but patients with well controlled HIV could be included in part II (negative viral load)\n8. Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection, symptomatic congestive heart fail-ure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or Posterior Reversible Encephalopathy Syn-drome (PRES).\n9. Mean resting QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 consecutive electrocardiograms using Fridericia's Correction.\n10. Active or prior documented inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n11. Patients unable to swallow orally administered medication, patients with gastrointestinal dis-orders likely to interfere with absorption of niraparib, and patients with long-term oral anticoagu-lant therapy.\n12. Pregnant or breast-feeding women. Participant must agree to not breastfeed during the study and for 30 days after the last dose of study treatment\n13. Known hypersensitivity to niraparib or capecitabine or any of the excipients of the products\n14. Patient is currently receiving or has received sorivudine or brivudine within 4 weeks prior to starting capecitabine\n15. Patient has received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy\n16. Patient has received colony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) ≤ 4 weeks prior to initiating protocol therapy\n17. Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \\> 4 weeks\n18. Patient has any known history of myelodysplastic syndrome (MDS) or acute myeloid leuke-mia (AML)\n19. Patient has a diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating study therapy with the following exceptions: basal or squamous cell carcinoma of the skin, cervical cancer in situ that has been definitively treated, adequately treated nonmelanoma skin cancer, ductal carcinoma in situ (DCIS) of the breast.\n20. Patient has known active hepatitis B (e.g. hepatitis B surface antigen (HBsAg\\] reaction) or hepatitis C (e.g. hepatitis C virus \\[HCV\\] ribonucleic acid \\[qualitative\\] is detected)\n21. Participants have received live vaccine within 30 days of planned start of study registration. 22. Participants have current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.",{"count":188,"type":21},[369,80],"This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.",[372],"2022-08-26",{"date":462,"type":31},"2022-08-29",{"date":464,"type":21},"2023-03",{"date":466,"type":21},"2027-12",{"name":37,"class":38},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":50,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":39},"100443425","immunological-profile-for-patients-treated-with-car-t-cells-100443425","NCT05054231","Immunological Profile for Patients Treated With CAR-T Cells","SI-CART","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Planned injection of CAR-T cells within the scope of marketing authorization\n* Signed informed consent\n* French social security affiliation\n\nExclusion Criteria:\n\n* Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women.\n* Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent\n* Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons",{"count":476,"type":21},500,[52],"In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.\n\nA cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed",[480],"Hematologic Neoplasms",[482,483],"CAR-T cells","Immunological Profile","2021-10-07",{"date":486,"type":31},"2021-10-15",{"date":488,"type":21},"2021-10-05",{"date":490,"type":21},"2026-10-05",{"name":37,"class":38},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":514},"100359569","monitoring-treatment-response-with-on-board-dwi-during-neo-adjuvant-chemo-radiation-for-rectal-cancer-using-magnetic-resonance-guided-radiotherapy-systems-100359569","NCT03961776","Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems","DWI_RECT_MRGRT","Inclusion Criteria:\n\n1. Patient over 18 years old.\n2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.\n3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1\n4. Signed consent to participation.\n5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment.\n6. Affiliation to a social security regimen, or beneficiary of such a regimen.\n\nExclusion Criteria:\n\n1. Predominant mucinous component on initial MRI, biopsy and \u002F or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.\n2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).\n3. Exclusive radiation therapy.\n4. Other associated neo-adjuvant treatment.\n5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.\n6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \\\u003C30 ml \u002F min),\n7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU \u002F capecitabine and \u002F or its excipients.\n8. Participation in a protocol with concurrent treatment.\n9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding\n10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his \u002F her consent.\n11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.",{"count":500,"type":21},39,"feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.",[503],"Rectal Adenocarcinoma",[505,506],"Diffusion weighted imaging","Radiation therapy","2021-05-05",{"date":509,"type":31},"2021-05-06",{"date":511,"type":31},"2020-06-08",{"date":308,"type":21},{"name":37,"class":38},2,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":186,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":50,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":4},"100397149","connected-prehabilitation-program-during-neo-adjuvant-chemotherapy-100397149","NCT04451369","Connected Prehabilitation Program During Neo Adjuvant Chemotherapy","Multicenter Randomized Study Comparing Neo Adjuvant Chemotherapy for Patients Managed for Ovarian Cancer With or Without a Connected Prehabilitation Program","TRAINING","Inclusion Criteria:\n\n1. Patient must have signed the written consent,\n2. Age ≥ 18 years,\n3. Patient with advanced ovarian cancer (AOC), FIGO Stage III - IV, undergoing surgery,\n4. Patient with neo adjuvant chemotherapy (min 3 cycles, max 6 cycles),\n5. Capability to perform a cardiopulmonary exercise test (CPET)\n6. Patient affiliated to the national \"Social Security\" regimen or beneficiary of this regimen.\n\nExclusion Criteria:\n\n1. Patient with cognitive impairment,\n2. Pregnancy,\n3. Neoadjuvant treatment contraindications,\n4. Physical adapted activity program contraindication,\n5. No possibility to have access to connected devices or do not have a smartphone or a computer\n6. Patient deprived of liberty or placed under the authority of a tutor,\n7. Patient considered socially or psychologically unable to comply with the procedure and the required medical follow-up.",{"count":524,"type":21},136,[52],"NACT is a heavy oncologic treatment, which can impair functional capacity, nutritional and emotional status. These three impairments are often ignored and not taken into account in the pre-therapeutic evaluations but are correlated with postoperative morbidity and mortality after major surgery.\n\nRecently, a prehabilitation before surgery, including physical, nutritional and psycho-social support, has been defined. From a literature review, the maximum oxygen uptake (VO2 max) seems to constitute a strong evaluation factor reflecting physical fitness, easily measured with a cardiopulmonary exercise test (CPET) at maximal effort.\n\nSeveral studies have shown beneficial effects of trimodal prehabilitation programs on postoperative functional capacity, return to daily activities and pain relief.\n\nHome-based program and connected devices may improve the feasibility and the compliance to this program.\n\nThe hypothesis of this study is that performing a connected supervised home-based and patient-tailored multimodal prehabilitation program from diagnosis to surgery (with or without ERAS program) during NACRT, for patients managed for ovarian cancer, will limit physical fitness alteration and will positively affect postoperative outcomes.\n\nOur study consists in an early and multidimensional (combining nutritional, physical, emotional and medical support) prehabilitation program during NACT for patients with ovarian cancer, in order to limit physical alteration before surgical treatment, and therefore improve postoperative outcomes. It will include a home-based prehabilitation program, in order to allow care access to all eligible patients.",[528],"Ovarian Cancer","2021-02-09",{"date":531,"type":31},"2021-02-10",{"date":533,"type":21},"2021-05",{"date":535,"type":21},"2027-09",{"name":37,"class":38},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100416603","prospective-database-for-colonic-or-rectal-resection-surgery-patients-100416603","NCT04704817","Prospective Database for Colonic or Rectal Resection Surgery Patients","CHIRCOLREC","Inclusion Criteria:\n\n1. Patients treated for colonic and \u002F or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,\n2. Patients over 18 years old,\n3. Affiliation to a social security scheme, or beneficiary of such a scheme.",{"count":545,"type":21},1000,"Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).",[548],"Colorectal Disorders","2021-01-08",{"date":551,"type":31},"2021-01-12",{"date":553,"type":21},"2021-03",{"date":555,"type":21},"2071-12",{"name":37,"class":38},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":50,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":4},"100397136","phase-2-sequential-and-personalized-pk-guided-busulfan-administration-in-the-frame-of-the-conditiong-regimen-for-allo-hsct-in-patients-with-malignant-hemopathies-ineligible-for-the-standard-myeloablative-conditioning-100397136","NCT04451200","Sequential and Personalized PK-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allo-HSCT in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning","Sequential and Personalized Pharmacokinetic-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning","BUSEQ","Inclusion Criteria:\n\n* Adult patient up to 65 years old\n* Acute leukemia, myelodysplastic syndrome or myeloproliferative neoplasia eligible for an allogeneic transplant\n* Chemosensitive disease, in complete or partial or stable remission\n* Allograft from an identical HLA related donor, Haplo-identical or unrelated (HLA compatibility from 8\u002F10 to 10\u002F10 according to HLA-A, -B, -C, -DR, -DQ allelics)\n* Signed consent to participate\n\n  -. Affiliation to a social security regimen or beneficiary of this regimen\n* Patient not eligible for standard myeloablative conditioning due to age\\> = 45 years and \u002F or the presence of an HCT-CI comorbidity score\\> = 3\n\nExclusion Criteria:\n\n* Pregnant woman, without effective contraception or breastfeeding\n* Person in emergency situation, patient deprived of liberty or placed under the authority of a tutor,\n* Impossibility of undergoing medical follow-up of the trial for geographic, social or psychological reasons\n* Contraindications to performing an allogeneic transplant\n* Previous allograft\n* Placental blood allograft","65 Years",{"count":271,"type":21},[80],"Because the anti-leukemic activity of busulfan, this dug is largely used in graft conditioning but in elderly and\u002For cormobid patienth an excess of toxicity is observed. This study focus on the possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual PK parameters.",[570,571,572],"Acute Leukemia","Mielodysplasic Syndrome","Myeloproliferative Neoplasm","2020-11-16",{"date":575,"type":31},"2020-11-17",{"date":577,"type":21},"2020-11",{"date":579,"type":21},"2028-12",{"name":37,"class":38},""]