[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ecog-performance-status-score-of-0-or-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ecog-performance-status-score-of-0-or-1":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100655314","phase-2-a-phase-ii-plateform-study-open-label-evaluating-the-efficacy-and-safety-of-neoadjuvant-treatment-in-patients-with-surgically-resecable-pancreatic-adenocarcinoma-100655314",false,"NCT07808567","Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.","A Phase II, Plateform Study, Open-label, Evaluating the Efficacy and Safety of Neoadjuvant Treatment in Patients With Surgically Resecable Pancreatic Adenocarcinoma","POWER","Inclusion Criteria:\n\n* Adult, age ≥ 18 years old at the time of signing the informed consent form.\n* Documented informed consent.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Tumor deemed resectable based on local assessment.\n* No evidence of distant metastases on CT scan or PET scan, as well as liver MRI prior to registration.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n* Adequate hematologic and organ function, defined by the following laboratory results obtained within 7 days prior to initiation of study treatment:\n\n  1. Neutrophils ≥ 1.5 × 10⁹\u002FL (≥ 1500\u002FµL) without granulocyte colony-stimulating factor support.\n  2. Platelet count ≥ 100 × 10⁹\u002FL (≥ 100,000\u002FµL) without transfusion.\n  3. Hemoglobin ≥ 90 g\u002FL (≥ 9 g\u002FdL). Patients may be transfused to meet this criterion.\n  4. AST, ALT, and ALP ≤ 3 × upper limit of normal (ULN).\n  5. Total bilirubin ≤ 1.5 × ULN.Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the MDRD formula).\n  6. Albumin ≥ 30 g\u002FL (≥ 2.5 g\u002FdL).\n  7. For patients not receiving anticoagulant therapy: INR and aPTT ≤ 1.5 × ULN.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required at 72-24 hours before starting the neo-adjuvant treatment. Sexually active female patients must agree to use two methods of effective contraception (cf. paragraph 7.10, one of them being a barrier method, or to abstain from sexual activity during the clinical investigation and for at least 6 months after last dose neoadjuvant treatment.\n* Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the neo-adjuvant treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration (see paragraph 6.12 \" Pregnancy and contraception \").\n* Patients shall be eligible to undergo neo adjuvant treatment, surgery and tumor biopsies.\n* Patients must be affiliated to a social security system or beneficiary of the same.\n* Additional specific sub-study inclusion criteria: Patient should also meet the potential specific eligibility criteria of the sub-study for which they are screened.\n\nExclusion Criteria:\n\n* Ongoing participation in clinical sub-study involving the use of an investigational product prior to registration in the sub-study.\n* During participation in this study, patients will not receive any other clinical investigational drugs or any other anti-tumor drugs as describes on sub-study.\n* Previous neoadjuvant or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, experimental therapy, or radiotherapy.\n* Uncontrolled tumor-related pain.\n* Pregnancy or breastfeeding Pregnant or breastfeeding women or intending to become pregnant during the study.\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.\n* No prior treatment including surgery, radiation therapy or systemic therapy for pancreatic adenocarcinoma.\n* Patients with a history of another primary malignancy diagnosed or requiring treatment within the 2 years prior to the first administration of the study drug. The following prior malignancies are not considered exclusion criteria, provided they have been treated with curative intent: completely resected basal cell carcinoma or squamous cell carcinoma of the skin; localized prostate cancer; superficial or non-invasive bladder cancer; or carcinoma in situ of any site.\n\nThis should be discussed with the oncologist if necessary.\n\n* Additional specific sub-study exclusion criteria: Patient should also meet the specific eligibility criteria of the sub-study for which they are screened.","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.\n\nIntervention: The procedure consists of administering a neoadjuvant treatment and then performing pancreatic surgery. The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study, in appendix. The surgery will be performed on one day and the end of the treatment is the safety visit post-surgery (90 days after surgery).",[27,28,29],"Pancreatic Adenocarcinoma Resectable","Non Metastatic","ECOG Performance Status Score of 0 or 1","NOT_YET_RECRUITING","2026-09-10",{"date":33,"type":34},"2026-09-15","ACTUAL",{"date":36,"type":21},"2027-01",{"date":38,"type":21},"2032-01",{"name":40,"class":41},"Gustave Roussy, Cancer Campus, Grand Paris","OTHER"]