[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma-of-the-pancreas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma-of-the-pancreas":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,67,89,114,144,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100432492","phase-1-neoadjuvant-mfolfirinox-with-perioperative-oral-hydroxychloroquine-in-resectable-pancreatic-adenocarcinoma-100432492",false,"NCT04911816","Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma","Phase I\u002FII Study of Neoadjuvant mFOLFIRINOX in Combination With Peri-operative Oral Hydroxychloroquine (FHQ) in Subjects With Resectable Adenocarcinoma of the Pancreas.","Inclusion Criteria\n\n* Subjects with biopsy-proven adenocarcinoma of the pancreas\n* Pancreatic protocol helical CT scan demonstrating absence of venous or arterial involvement, consistent with NCCN guidelines for resectable disease\n* ECOG performance status ≤ 1\n* No active second malignancy except for basal cell carcinoma of the skin\n* Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:\n\n  * Serum creatinine level ≤1.5 the upper limits of normal\n  * Serum total bilirubin level ≤1.5 X ULN\n* White blood cell count ≥ 3.5x109\u002Fml per ml and platelet count ≥ 100x109 per ml\n* For subjects with obstructive jaundice, the biliary tract must be drained with a temporary plastic or a short permanent metallic biliary stent\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection.\n* Subjects who have received chemotherapy within 12 months prior to study entry.\n* Subjects who are found to have loss-of-function mutations in DPYD or UGTA1 by Oneome pharmacogenomic testing, resulting in increased risk of mFOLFIRINOX toxicity. DPYD mutations have been noted in 5% of the overall population. Homozygous UGT1A1 mutations have been noted in 10% of North Americans.\n* Prior use of radiotherapy or investigational agents for pancreatic cancer.\n* Any evidence of metastasis to distant organs (liver, lung, peritoneum).\n* Cross sectional imaging suggesting portal vein, superior mesenteric artery, hepatic artery involvement that would make the patient borderline resectable or locally advanced\n* Symptomatic or endoscopic evidence of gastric outlet obstruction.\n* Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin.\n* Inability to adhere to study and\u002For follow-up procedures.\n* History of allergic reactions or hypersensitivity to the study drugs (chloroquine, hydroxychloroquine, 5-Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan).\n* Other concurrent experimental therapy.\n* The effects of HCQ, and mFOLFIRINOX on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well.\n* Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HCQ and mFOLFIRINOX is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future.\n* Due to the risk of disease exacerbation, patients with porphyria are ineligible.\n* Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations.\n* Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded.\n* Patients with previously documented macular degeneration or diabetic retinopathy are excluded.\n* Baseline EKG with QTc \\>470 msec (including subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This will be a phase I\u002FII trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or EUS. Eligible subjects with biopsy-proven, resectable pancreatic adenocarcinoma without evidence of venous or arterial involvement on CT scan receive HCQ orally in combination with mFOLFIRINOX prior to surgery. Hydroxychloroquine will begin with the first dose of mFOLFIRINOX and continue for 2 weeks post-operatively. Three to six weeks after the last dose of mFOLFIRINOX, patients will undergo surgical exploration and pancreatectomy if technically feasible and all toxicities have resolved. Pathologic specimens will undergo detailed histopathologic and immunohistochemical evaluations with particular attention to the six surgical margins of resection: the bile duct margin (for Whipple specimens), the margin of pancreatic transection, the retroperitoneal margin, the proximal and distal duodenal margins (for Whipple specimens), and the portal vein margin along the pancreatic head (for Whipple specimens) or medial pancreas (for distal pancreatectomies). Tissue specimens will be stored at -80C for future correlative studies of autophagy and tumor response to protocol therapy. Ten to fourteen weeks following completion of successful surgical removal of their tumor, subjects will undergo repeat staging studies per standard of care. Subjects will pursue standard of care adjuvant therapy options at the discretion of their physician.",[27],"Adenocarcinoma of the Pancreas","RECRUITING","2026-04-14",{"date":31,"type":32},"2026-04-20","ACTUAL",{"date":34,"type":32},"2021-07-16",{"date":36,"type":20},"2030-06",{"name":38,"class":39},"West Virginia University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100619094","resectionsynchronous-pulmonary-or-hepatic-oligometastatic-pancreatic-ductal-adenocarcinoma-100619094","NCT07340151","Resection\u002FSynchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma","Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC) Following Pre-operative Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluoracil\u002FFolinic Acid (NALIRIFOX): A Phase II Open-Label Single Arm Trial","PHOLIPANC","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas\n2. Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography\u002FMagnetic Resonance Imaging (CT\u002FMRI) that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT\u002FMRI can be done at an outside facility but must be reviewed by a local radiologist.\n\n   * Definition of limited hepatic metastasis: 1 to 5 metastases in CT\u002FMRI, which are potentially resectable or treatable by ablative procedures.\n\n     * Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT\u002FMRI scan at screening.\n     * Note 2: If more than 5 metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT\u002FMRI scan at screening.\n   * Definition of limited pulmonary metastasis: 1 to 4 pulmonary nodules seen on CT\u002FMRI, suspicious for pulmonary metastases as per the multidisciplinary tumor board radiologist and surgeon.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Patients ≥18 years at the time of signing the informed consent\n5. Being a candidate for chemotherapy with NALIRIFOX\n6. Patient's written informed consent prior to any trial-specific procedure\n7. Patient's legal capacity to consent to participation in the clinical trial.\n\nExclusion Criteria:\n\n1. Acinar cell carcinoma and\u002For neuroendocrine carcinoma of the pancreas\n2. Symptomatic clinically significant ascites\n3. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.\n4. Evidence of simultaneous pulmonary and hepatic metastases\n5. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given.\n6. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1 staging where Ta=non-invasive; Tis=high-grade, flat non-invasive cancer in situ; T1=relatively small primary tumor that has not spread to surrounding tissues)\n7. Known Human immunodeficiency virus (HIV) seropositivity\n8. Known active or chronic Hepatitis B or Hepatitis C infection\n9. Known glucuronidation deficiency (Gilbert's syndrome)\n10. Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his\u002Fher safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders",{"count":19,"type":20},[51],"NA","This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group.\n\nPatients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy).\n\nIf the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study.\n\nIf the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care.\n\nIf the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.",[27],[55,56,57,58],"Oligometastatic disease","Hepatic oligometastatic adenocarcinoma of the pancreas","Pulmonary oligometastatic adenocarcinoma of the pancreas","Surgical resection","2026-04-09",{"date":29,"type":32},{"date":62,"type":32},"2026-03-02",{"date":64,"type":20},"2028-12",{"name":66,"class":39},"The University of Texas Health Science Center at San Antonio",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100502384","phase-2-valproic-acidsimvastatin-plus-gemcitabinenab-paclitaxel-based-regimens-in-untreated-metastatic-pancreatic-adenocarcinoma-patients-100502384","NCT05821556","Valproic Acid\u002FSimvastatin Plus Gemcitabine\u002FNab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients","Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine\u002FNab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Histologically or cytologically proven metastatic PDAC.\n3. No prior treatments (chemotherapy, radiation or surgery) for PDAC\n4. Either sex aged ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 at study entry.\n6. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n7. Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme.\n8. Adequate bone marrow haematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL AND platelet count ≥ 100 x 109\u002FL AND haemoglobin ≥ 9 g\u002FdL.\n9. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n10. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n\nExclusion Criteria:\n\n1. Prior malignancy within one year. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated \\> 6 months previously).\n3. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.\n4. Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.\n5. Proven hypersensitivity to statins and to any component of the other medications used in the trial.\n6. Major surgical intervention within 4 weeks prior to enrollment;\n7. Pregnancy and breast-feeding.\n8. Brain metastasis.\n9. Hepatitis or any severe liver disorder.\n10. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n11. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix).\n12. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n13. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n14. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.\n15. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 6 months after the last trial treatment.",{"count":75,"type":20},240,[24],"This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.",[27],[80],"Metastatic",{"date":29,"type":32},{"date":83,"type":32},"2023-06-12",{"date":85,"type":20},"2027-06",{"name":87,"class":39},"National Cancer Institute, Naples",5,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":40},"100537821","the-histosonics-edison-system-for-treatment-of-pancreatic-adenocarcinoma-using-histotripsy-100537821","NCT06282809","The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy","GANNON","Inclusion Criteria:\n\n1. Subject is ≥18 years of age.\n2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests\u002Fprocedures and is willing to comply with trial procedures and required follow-up assessments.\n3. Subject is diagnosed with unresectable pancreatic adenocarcinoma (locally advanced \\[Stage 3\\] or oligometastatic disease \\[Stage 4\\]) confirmed via CT or MR imaging ≤14 days prior to the planned index procedure.\n\n   NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors, the tumors must be located only in the liver and\u002For lung, and the metastatic tumors must be stable.\n4. Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.\n5. Subject can tolerate general anesthesia.\n6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.\n7. Subject meets the following criteria ≤14 days prior to the planned index procedure date:\n\n   * Hemoglobin ≥ 9 g\u002FdL,\n   * Neutrophil count \\>1.0 x 10\\^9\u002FL,\n   * Platelet \\>50 x 10\\^9\u002FL,\n   * Total bilirubin ≤2.5x Institutional Upper Limit of Normal (IULN),\n   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5x IULN,\n   * International Normalized Ratio (INR) value \\\u003C1.5,\n   * Serum creatinine \\\u003C2.0mg\u002FdL or an estimated glomerular filtration rate (eGFR) ≥45mL\u002Fmin.\n8. The targeted pancreatic tumor is ≥2 cm in longest diameter.\n9. The planned histotripsy treatment volume is ≥1.0 cm from any portion of the duodenum, small intestine, stomach, or colon as visualized on ultrasound, and CT, or MR imaging.\n10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.\n11. Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors are present in the pancreas.\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.\n2. Subject has had prior pancreatic, bilioenteric, or gastric surgery.\n3. Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.\n4. Subject has an uncorrectable coagulopathy.\n5. Subject has a life expectancy of less than six (6) months.\n6. Subject has a biliary or pancreatic stent and\u002For percutaneous biliary tube that encompasses the planned histotripsy treatment volume.\n7. Subject has metastases to organs other than the liver and\u002For lung (e.g., bone, brain, peritoneum).\n8. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.\n9. Subject has an active duodenal or gastric ulcer requiring medical management.\n10. Subject is undergoing active chemotherapy for any cancer ≤7 days prior to planned index procedure date.\\*\n11. Subject is undergoing active immunotherapy or targeted therapies ≤30 days prior to planned index procedure date.\n12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation).\n13. Subject has a planned cancer treatment (e.g., pancreatic surgery, targeted therapy, immunotherapy) exclusive of chemotherapy, ≤30 days post index procedure.\n14. Subject has planned chemotherapy ≤14 days post index procedure.\\*\n15. Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency).\n16. In the investigator's opinion, histotripsy is not a treatment option for the subject.\n17. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.\n18. Subject's tumor is not treatable by the System's working ranges (refer to User Guide).\n\n(\\*) Subject must not be off chemotherapy \\>21 days in total.",{"count":97,"type":20},50,[51],"The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.",[101,27,102,103],"Pancreas Cancer","Pancreatic Cancer","Tumor of Pancreas","2026-01-14",{"date":106,"type":32},"2026-01-15",{"date":108,"type":32},"2024-12-10",{"date":110,"type":20},"2027-01",{"name":112,"class":113},"HistoSonics, Inc.","INDUSTRY",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":40},"100448178","phase-1-efficacy-and-safety-of-tpiat-for-resectable-adenocarcinoma-of-the-pancreas-region-at-high-risk-of-postoperative-fistula-100448178","NCT05116072","Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula","Efficacy and Safety of Total Pancreatectomy With Intraportal Islet Autotransplantation for Resectable Adenocarcinoma of the Cephalic Region of the Pancreas at High-risk of Postoperative Fistula and Requiring Systemic Adjuvant Chemotherapy","TPIAT-01","Inclusion criteria\n\nInclusion criteria are composed of preoperative conditions validated by intraoperative confirmation to plan an exit of the protocol if the pancreas does not finally appear with a high-risk of CR-POPF.\n\n* Age ≥ 18 years\n* Locale resectable invasive adenocarcinomas located in the cephalic region of the pancreas documented by endoscopic ultrasonography with fine-needle aspiration biopsy\n* pancreatic adenocarcinoma;\n* duodenal adenocarcinoma;\n* ampullary adenocarcinoma;\n* and IPMNs with adenocarcinoma degeneration;\n* A potentially curative strategy with primary tumor resection approved by a multidisciplinary expert team\n* A high-risk of CR-POPF\n\n  1. Suspected during preoperative evaluation by the presence of 2 or more of the following criteria (screening criteria of inclusion) : sex male;an obesity (BMI ≥ 30 kg\u002Fm2);a main pancreatic duct diameter ≤ 3 mm on preoperative endoscopic ultrasonography a visceral obesity (i.e. a visceral fat area \\> 84 cm2) ; a sarcopenia (i.e. a skeletal muscle index \\\u003C 43 cm2\u002Fm2 in men with a BMI of \\\u003C25 kg\u002Fm2 or \\\u003C53 cm2\u002Fm2 in men with a BMI of ≥25 kg2\u002Fm2, and \\\u003C41 cm2\u002Fm2 in women)\n  2. and validated during intraoperative evaluation (finale inclusion) by a probability score above or equal to 20% on the validated updated alternative Fistula Risk Score ua-FRS for pancreaticoduodenectomy (ua-FRS) based of pancreas texture, duct size, BMI, sex .\n* Women of childbearing potential should only be included after a confirmed menstrual period, and a negative highly sensitive urine or serum pregnancy test and must agree to be subjected to a monthly pregnancy test (urine or blood) until the end of the relevant systemic exposure to chemotherapy agents, in accordance with current CTFG recommendations (Recommendations related to contraception and pregnancy testing in clinical trials);\n* Women of child-bearing potential and male subjects must agree to use a birth control methods which may be considered as highly effective (failure rate of less than 1% per year ) as recommended by the CTFG (Cinical Trials Facilitation and Coordination Group, version 1.1). These recommandations related to contraception and pregnancy testing in clinical trials suggested such method (see below) that will be use during chemotherapy exposure for included women of child-bearing potential and woman of child-bearing potential when partner of included male : combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal) ; progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable) ; intrauterine device (IUD) ; intrauterine hormone-releasing system ( IUS) ; bilateral tubal occlusion; vasectomised partner ;sexual abstinence For included male partner of a women of child-bearing potential, contraception with condom.\n\nContraception will be perform during the relevant systemic exposure to chemotherapy agents and will be extended by 6 months for women of childbearing potential and by 1 month for men included as recommended by the CTFG\n\n* Patient covered by a health insurance system\n* Patient who provides a written informed consent to participate to the study\n\nExclusion criteria\n\n* Patient will be screened and excluded if they present a preoperative diabetes defined by a stimulated C-peptide \\\u003C 0.5 ng\u002FmL relative to blood glucose \\> 2 g\u002FdL, at 2 hours in post prandial\n* Patients with a known or highly suspected genetic syndrome associated with a risk of pancreatic adenocarcinoma: familial pancreatic cancer, multiple familial melanoma, Peutz-Jeghers syndrome, hereditary chronic pancreatitis, cystic fibrosis, familial breast Ovarian Cancer, Lynch syndrome, adenomatous polyposis family, Li Fraumeni syndrome, Multi-endocrine disorder type I;\n* Multifocal pancreatic adenocarcinomas identified during preoperative evaluation;\n* Performance status and comorbidity profile inappropriate for a major abdominal surgery;\n* Contraindication for autologous islet intraportal transplantation\n* Current or indicated\u002Fscheduled neoadjuvant chemotherapy;\n* Extra pancreatic metastasis identified during preoperative evaluation (high-definition cross-sectional imaging with thorax-abdomen-pelvis multi-detection computed tomography or abdominal MRI with T1, T2 and diffusion weighted sequences) or during intraoperative assessment (clinical examination and ultrasonography);\n* Need for complex vascular reconstructions (endovascular treatment or release of the arcuate ligament will be not considered as complex vascular reconstructions), major vein reconstructions will exclude the patients because of the over-risk of portal thrombosis following islet intraportal infusion.\n* evident macroscopically or biologically proved post biliary drainage pancreatitis that jeopardize islet isolation\n* Known infection or positive serology performed at screening for human immunodeficiency virus (HIV) infection, Hepatitis B or C virus infection, HTLV infection or syphilis infection.\n* Active infection for SARS-CoV-2 virus (positive PCR), which will require rescheduling of the intervention 30 days later.\n* Pregnant or breastfeeding woman\n* Dihydropyrimidine dehydrogenase total deficiency\n* Ethics \u002F regulatory criteria :\n\n  * Person unable to understand purposes, benefits and risks of the study and\u002For unable to provide a written informed consent.\n  * Person unable to comply with the whole study schedule.\n  * Person not covered by a health insurance system.\n  * Person kept in detention and\u002For receiving psychiatric medical care and\u002For patients admitted in a social or medical sanatorium.\n  * Person in an emergency situation.",{"count":123,"type":20},36,[23,24],"Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula.\n\nPostoperative complications following pancreaticoduodenectomy can lead to early discontinuation of the complete oncologic strategy, i.e., chemotherapy for malignancy is performed in only about a third of patients who experienced a grade C fistula.\n\nA total pancreatectomy rather than a pancreaticoduodenectomy is an alternative procedure that involves the complete and definitive resection of all pancreatic tissue, eliminating any risk of postoperative pancreatic fistula but is associated with unavoidable endocrine insufficiency and potentially severe metabolic complications, such as \"brittle diabetes\".\n\nTotal Pancreatectomy following by intraportal Islet AutoTransplantation (TPIAT) can prevent \"brittle diabetes\" and improve the quality of life. The endocrine islets can be isolated from the pancreatic surgical specimen with standardized procedures and transplanted in the liver through intraportal infusion, in absence of immunosuppression and allow adequate control of glucose metabolism with a reduced need for exogenous insulin and an effective graft function in 70% of cases at 3 years Thereby, the investigators hypothesize that total pancreatectomy with intraportal Islet autotransplantation rather than classical pancreaticuduodenectomy, in patients with high-risk of postoperative fistula will increase the rate of complete access to adjuvant chemotherapy, while maintaining an adequate metabolic control.",[27,127,128],"Adenocarcinoma of the Duodenum","Ampullary Adenocarcinoma",[130,131,132,133,134],"the cephalic region of the pancreas","total pancreatectomy","postoperative pancreatic fistula","islet transplantation","adenocarcinoma","2025-09-24",{"date":137,"type":32},"2025-09-25",{"date":139,"type":32},"2022-02-20",{"date":141,"type":20},"2030-02-20",{"name":143,"class":39},"University Hospital, Lille",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100560837","is-the-3d-panc-msp-model-superior-to-ct-for-assessing-response-to-neoadjuvant-treatment-in-pca-patients-100560837","NCT06582342","Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?","Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?","Inclusion Criteria:\n\n\\- Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas, as defined by the National Comprehensive Cancer Network (NCCN), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age.\n* Patients under 18 years of age.\n* Disease progression during neoadjuvant treatment.\n* No preoperative CT scan.\n* Refusal to participate in the study.",{"count":152,"type":20},70,"OBSERVATIONAL","Prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).",[27],"2025-08-05",{"date":158,"type":32},"2025-08-06",{"date":160,"type":32},"2024-03-21",{"date":162,"type":20},"2025-12-30",{"name":164,"class":39},"Fundación para la Investigación del Hospital Clínico de Valencia",17,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100404187","phase-2-chemo4metpanc-combination-chemokine-inhibitor-immunotherapy-and-chemotherapy-in-pancreatic-adenocarcinoma-100404187","NCT04543071","Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma","A Phase 2 Study With Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (BL-8040), and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma","Inclusion criteria:\n\n1. Histological or pathological confirmation of metastatic pancreas adenocarcinoma\n\n   1. Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-treatment biopsy, prior to initiation of any study-related therapy.\n   2. Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy.\n   3. Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. Age ≥18 years\n4. Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment):\n\n   1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL without granulocyte colony-stimulating factor support\n   2. White Blood Cell Count (WBC) count ≥ 2.5 x 109 \u002FL (2500\u002FuL)\n   3. Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FuL)\n   4. Platelet count ≥ 100 x 109\u002FL (100,000\u002FuL) without transfusion\n   5. Hgb ≥ 9.0 g\u002FdL\n   6. Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) ≤ 2.5X upper limit of normal (ULN), unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to initiation of therapy\n   7. Serum total bilirubin ≤ 1.5X ULN, unless in patients with known Gilbert disease (≤ 3X ULN), or unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to administration of investigational therapy\n   8. Albumin ≥ 3.5 g\u002FdL\n   9. Creatinine within ULN or calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin using the Cockcroft-Gault formula\n   10. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5X ULN, except for those on stable anticoagulation for at least two weeks\n5. Measurable disease according to Immune Modified (IM)-RECIST and tumor accessible for fresh biopsy\n6. Negative pregnancy test: Women of child-bearing potential must have a negative serum pregnancy test at screening and must agree to use an effective form of contraception from the time of the negative pregnancy test until a minimum of 3 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive (injectable or implantable) in conjunction with a barrier method. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.\n7. Birth control agreement: Fertile men must agree to use an effective method of birth control with female partners of childbearing potential (condoms plus an additional contraceptive method such as an injectable or implantable hormonal contraceptive) during the study and for up to 3 months after the last dose of study drug.\n8. Informed consent: Participants must be willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.\n9. Ability to comply: Participants must be able to comply with the study protocol, according to the investigator's judgement.\n10. DVT testing Participants must have undergone lower extremity dopplers to rule out deep venous thrombosis (DVT) within the screening period, and undergo therapeutic anticoagulation if evidence of DVT is identified.\n11. Anticoagulation treatment Subjects who are stable on full-dose anticoagulation medication for at least 2 weeks are considered eligible. However, subjects who have an increased clot burden on full-dose anticoagulation, such as central pulmonary embolism, or peripheral pulmonary embolism, and DVT within the extremities will be considered eligible only with the approval of the Principal Investigator.\n\nExclusion criteria:\n\n1. Prior systemic therapy for PDAC: Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies) prior to initiation of study treatment.\n2. Prior radiation therapy for PDAC Participants may not have had radiation therapy to within two weeks prior to initiation of study treatment. Participants may not have had previous radiotherapy to the primary pancreas lesion or a metastatic site except for palliation for pain. Participants who receive radiation to 25% or more of the bone marrow will be excluded.\n3. Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment\n4. Patients currently receiving any other investigational agents\n5. Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 or better, with the exception of alopecia of any grade and Grade ≤ 2 peripheral neuropathy\n6. Concomitant treatment with other anti-neoplastic agents (hormone therapy acceptable)\n7. Uncontrolled pleural effusion, pericardial effusion, or ascites. Subjects who required drainage within the four weeks prior or require pleural, pericardial, or peritoneal catheters for drainage are ineligible.\n8. Uncontrolled tumor-related pain Patients requiring narcotic pain medication must be on a stable regimen for at least two weeks prior to study entry.\n9. History of leptomeningeal or brain\u002F Central Nervous System (CNS) metastases\n10. Uncontrolled hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.\n11. Recent major surgery or significant traumatic injury Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment, or be recovering from procedure related adverse events of \\> Grade 1.\n12. Active or history of autoimmune disease or immune deficiency Includes, but is not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on stable thyroid-replacement hormone for the past three months are eligible for the study.\n    2. Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen for the past month are eligible for the study.\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * Rash must cover \\\u003C10% of body surface area;\n       * Disease is well-controlled at baseline and requires only low-potency topical corticosteroids;\n       * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n13. History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan (history of radiation pneumonitis or fibrosis in the radiation field is permitted).\n14. Positive for HIV at screening or any time prior to screening Patients without prior positive HIV test result will undergo an HIV test at screening, unless not permitted under local regulations.\n15. Hepatitis B virus (HBV) infection (chronic or acute) Defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study.\n16. Active hepatitis C virus (HCV) infection: Defined as positive HCV antibody test followed by a positive HCV RNA test at screening.\n\n    The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n17. Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease.\n18. Active tuberculosis\n19. Infection: Patients may not have had a severe infection requiring antibiotic treatment within the two weeks prior to initiation of study treatment. This includes, but is not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. However, patients who were admitted for biliary tract infection due to bile duct obstruction at time of diagnosis must have a functioning biliary stent (as evidenced by declining total bilirubin and ≤ 2X ULN) and resolved infection (defined by normalization of elevated white blood cell count, absence of signs of infection) and completion of an antibiotic course (at least a seven-day course) prior to initiation of therapy. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n20. Significant cardiovascular disease: Patient may not have significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, seizure disorder, uncontrolled hypertension, or unstable arrhythmia or unstable angina within 3 months prior to initiation of study treatment.\n21. Left ventricular ejection fraction below institutional lower limit of normal or below 50%, whichever is lower.\n22. Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)\n23. Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment\n24. Prior autologous stem cell, allogeneic stem cell, or solid organ transplantation\n25. History of other malignancy Patient may not have a history of malignancy other than PDAC within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5- year overall survival of \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n26. Recent vaccination: Patients may not have been treated with a live, attenuated vaccine within four weeks prior to initiation of study treatment, or anticipate the need for such a vaccine during treatment with cemiplimab or within five months after the last dose of cemiplimab.\n27. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n28. Known allergy or hypersensitivity to any of the study drug excipients\n29. Recent immunosuppressive treatment: Patients may not have been treated with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor alpha agents) within two weeks prior to initiation of study treatment, or anticipate the need for systemic immunosuppressive medication during the course of the study, with the following exceptions:\n\n    a. Patients who received a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after approval from the Principal Investigator.\n30. Pregnancy: Pregnant women are excluded from this study because there is an unknown, but potential risk for adverse events to the fetus. Breastfeeding should be discontinued prior to start of treatment because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment.\n31. Other contraindicated conditions Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator.\n32. Uncontrolled psoriasis, porphyria, proximal myopathy or neuropathy\n33. Severe depression Subjects hospitalized for depression within the past two years, or who have prior suicidal attempts will be excluded.\n34. Has received transfusions of blood products (including platelets or red blood cells) within 4 weeks prior to study Day 1.\n35. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study if receiving equivalent to ≤ 10 mg of prednisone daily (10mg prednisone is equivalent to either cortisone - 50mg; hydrocortisone - 40mg; triamcinolone - 8mg; prednisolone - 10mg; methylprednisolone - 8mg; betamethasone - 1.5mg; or dexamethasone - 1.5mg). Patients receiving \\> 10 mg of prednisone or equivalent per day for greater than five days within 28 days of starting study related therapy are not eligible. Steroids administered prior to gemcitabine and nab-paclitaxel should be administered as per standard institutional guidelines.",{"count":174,"type":20},10,[24],"The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.",[102,27,178],"Adenocarcinoma","2025-06-16",{"date":181,"type":32},"2025-06-19",{"date":183,"type":32},"2020-11-09",{"date":185,"type":20},"2028-08",{"name":187,"class":39},"Gulam Manji",3]