[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-adenocarcinoma-resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-adenocarcinoma-resectable":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":42},"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",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100590363","adjuvant-pancreatic-therapy-guided-by-mrd-100590363","NCT06966440","Adjuvant Pancreatic Therapy Guided by MRD","Assessing the Impact of Ct-DNA MRD-Guided Adjuvant Therapy on Outcomes in Resectable Pancreatic Cancer","ADAPT-MRD","Inclusion Criteria:\n\n* Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule\n* Male or female aged 18-75 years at the time of ICF signing.\n* Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.\n* Time between surgery and randomization ≤ 12 weeks.\n* ECOG PS 0-2.\n* Fully recovered from surgery and able to receive adjuvant chemotherapy.\n* Availability of sufficient tumor tissue for MRD testing.\n* Patients with reproductive potential (female patients: must have entered the study after the menstrual period and with a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one used by the patient and one by their partner) during the study and for 4 months (for females) or 6 months (for males) after the last study treatment.\n\nExclusion Criteria:\n\n* Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.\n* Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate\u002Fsevere renal impairment (GFR \\\u003C 30 ml\u002Fmin) calculated using the Cockcroft-Gault equation. b) Absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL. c) Platelet count \\\u003C 100 × 10\\^9\u002FL. d) Hemoglobin \\\u003C 90 g\u002FL. e) Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) \\> 2.5 × the upper limit of normal.\n* Pregnant or breastfeeding women.\n* Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B, hepatitis C, HIV, etc.), which the investigator deems unsuitable for participation in the study or likely to affect compliance with the study protocol.\n* Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin)\n* Other conditions that the investigator deems unsuitable for participation in the study.","75 Years",{"count":53,"type":21},856,[55],"NA","Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. This study will explore the application of ctDNA MRD in guiding adjuvant therapy in these patients.\n\nThis prospective, randomized, interventional trial will evaluate a ct-DNA MRD-guided adjuvant therapy strategy in PAAD patients who have undergone radical resection at our institution. Prior to adjuvant chemotherapy, patients will be randomized (1:1) to either the experimental arm (Arm A) or the control arm (Arm B). Arm A will receive ct-DNA MRD-guided therapy, while Arm B will receive non-ctDNA-driven standard of care post-operative adjuvant therapy.\n\nIn Arm A, patients will receive a physician-selected, guideline-recommended adjuvant therapy regimen in 12-week cycles. ctDNA MRD will be assessed before the end of first cycle and at weeks 8 and 11. If two consecutive post-treatment MRD tests are negative, therapy will be \"de-escalated\" (discontinued) with regular follow-up as determined by the clinician. Otherwise, another treatment cycle will be administered, with the same MRD assessment. Following the second cycle, patients without two negative MRD results (only tested at week 8 and week 11 within each cycle) will \"escalate\" to a longer duration of chemotherapy (comparing to the 6-month standard of care) at the clinician's discretion. Treatment will continue until disease progression, intolerance, or study termination.\n\nArm B will receive standard post-operative adjuvant therapy for a duration recommended by CSCO guidelines (typically 6 months), followed by regular follow-up every 8 weeks.\n\nThe primary endpoint is to compare the prognosis, tolerability, and treatment completion rates between the two arms.",[27],"RECRUITING","2025-07-09",{"date":61,"type":34},"2025-07-15",{"date":63,"type":34},"2025-06-01",{"date":65,"type":21},"2030-06-01",{"name":67,"class":41},"Ruijin Hospital"]