[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pdac---pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pdac---pancreatic-ductal-adenocarcinoma":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,57,89,116,143,169,191,241,270,319,342,367,392,416,450,476,497,524,543,569,601,623,662,693,722],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100630728","phase-3-study-of-daraxonrasib-and-daraxonrasib--gnp-as-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100630728",false,"NCT07491445","Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma","RASolute 303","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.\n* Documented RAS mutation status, either mutant or wild-type.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.","ALL","18 Years",{"count":21,"type":22},900,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.",[28,29,30,31,32,33,34,35],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Pancreatic Adenosquamous Carcinoma",[28,30,37,38,39,40,41,42,43,29,33,35,34],"Pancreatic Ductal Adenocarcinoma","RAS","KRAS","NRAS","HRAS","RAS Wild-Type","RAS Mutation","RECRUITING","2026-06-24",{"date":47,"type":48},"2026-06-25","ACTUAL",{"date":50,"type":48},"2026-03-09",{"date":52,"type":22},"2029-03",{"name":54,"class":55},"Revolution Medicines, Inc.","INDUSTRY",13,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100636166","phase-3-atebimetinib--gnp-as-a-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100636166","NCT07562152","Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","MAPKeeper 301","Inclusion Criteria:\n\n* Must be ≥18 years of age\n* Must have confirmed diagnosis according to AJCC staging as follows:\n\n  * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must be treatment naive as follows:\n\n  * First-line PDAC participants will have received no previous systemic anti-cancer therapy\n* Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria\n* Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values\n\nExclusion Criteria:\n\n* Inability to swallow oral medications\n* Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Participants with only locally advanced disease\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases",{"count":66,"type":22},510,[25],"The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.",[28,29,30,31,37,33,32,34],[71,72,73,74,75,76,77,78],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","2026-06-18",{"date":81,"type":48},"2026-06-22",{"date":83,"type":22},"2026-06",{"date":85,"type":22},"2029-02",{"name":87,"class":55},"Immuneering Corporation",19,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100631406","exploratory-clinical-evaluation-of-personalized-functional-profiling-in-gi-tumors-predicting-drug-response-in-crc-and-pdac-100631406","NCT07500259","Exploratory Clinical Evaluation of Personalized Functional Profiling in GI Tumors: Predicting Drug Response in CRC and PDAC","COLOPan","Inclusion Criteria:\n\n* Signed informed consent form\n* ≥ 18 years of age\n* Willing and able to comply with the protocol for the duration of the study, including data and sample collection\n* Patient scheduled for surgery or biopsy (primary tumour or metastasis) PDAC\n\nExclusion Criteria:\n\n* Female patient, pregnant, planning a pregnancy or breastfeeding.\n* Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.\n* Patient unable to understand and provide informed consent and has no family member representing him\u002Fher.\n* Patients with any other life-threatening illness, significant organ dysfunction or any clinically relevant conditions that, according to the hospital physician, could compromise the patient's safety.",{"count":97,"type":22},188,"OBSERVATIONAL","The ColoPan study evaluates the scientific validity, reproducibility, and predictive performance of the Personalised Functional Profiling (PFP) platform in colorectal cancer and pancreatic ductal adenocarcinoma patients. It combines genomic sequencing with in vitro functional drug testing using patient-derived spheroids\u002Forganoids.",[101,31],"Colorectal Cancer",[103,104,105],"Drug profiling","Precision medicine","clinical validation","NOT_YET_RECRUITING",{"date":108,"type":48},"2026-06-23",{"date":110,"type":22},"2026-07-01",{"date":112,"type":22},"2034-11-01",{"name":114,"class":115},"Luxembourg Institute of Health","OTHER_GOV",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100612334","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-resected-pancreatic-ductal-adenocarcinoma-pdac-100612334","NCT07252232","Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)","RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and\u002For Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)","RASolute 304","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed PDAC with successful (R0\u002FR1) curative intent surgical resection and no evidence of recurrent or metastatic disease.\n* Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.\n* Must have completed most recent treatment within the past 12 weeks.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Documented RAS mutation status.\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":125,"type":22},500,[25],"The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.",[28,30,31,129,130],"Resectable Pancreatic Ductal Adenocarcinoma (PDAC)","Resected Pancreatic Adenocarcinoma",[28,30,37,38,39,40,41,42,132,133,134,130,43],"RASolute","Resectable Pancreatic Ductal Adenocarcinoma","Resectable PDAC","2026-06-17",{"date":81,"type":48},{"date":138,"type":48},"2025-12-15",{"date":140,"type":22},"2030-07-10",{"name":54,"class":55},34,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":168},"100641695","biophotonic-nanoparticle-enabled-laser-blood-test-for-early-detection-of-pancreatic-cancer-100641695","NCT07659639","Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer","LASERBLOOD","\\*\\*Inclusion criteria for patients with PDAC and IPMN:\\*\\*\n\n* No history of prior neoplastic diseases;\n* Adequate renal and hepatic function;\n* No hematologic disorders;\n* Age ≥ 18 years;\n* No active infections;\n* Written informed consent.\n\n\\*\\*Exclusion criteria:\\*\\*\n\n* Severe pre-existing medical conditions, such as serious illnesses or other medical conditions that could negatively affect study outcomes or pose a high risk to the patient's health;\n* Ongoing therapies that could interfere with the study or alter the results.",true,{"count":152,"type":22},400,[154],"NA","LASERBLOOD is based on a biophotonic technology that can be used to predict the development of Pancreatic Ductal Adenocarcinoma (PDAC) in particular categories of subjects at risk (e.g. persons with diabetes, obese people, patients with Intraductal Papillary Mucinous Neoplasm \\[IPMN\\] or other cystic diseases of the pancreas, etc.) and at the same time offer the possibility of verifying the real effectiveness of the treatments to which affected patients are subjected.",[157,158,31],"Diabetes","IPMN, Pancreatic","2026-06-16",{"date":81,"type":48},{"date":162,"type":48},"2025-09-01",{"date":164,"type":22},"2029-08",{"name":166,"class":167},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",1,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100641682","phase-3-study-of-zoldonrasib--chemo-of-investigators-choice-vs-placebo--chemo-of-investigators-choice-as-first-line-treatment-in-metastatic-kras-g12d-mutated-pancreatic-adenocarcinoma--rasolute-305--100641682","NCT07621718","Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","RASolute 305","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":178,"type":22},670,[25],"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.",[28,29,30,31,32,33,34,35],[28,30,37,38,39,43,29,33,35,34],"2026-06-12",{"date":159,"type":48},{"date":186,"type":48},"2026-05-22",{"date":188,"type":22},"2030-04-22",{"name":54,"class":55},3,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":202,"conditions":203,"keywords":208,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":238,"locationsCount":240},"100580305","phase-1-a-study-to-learn-about-study-medicine-alta3263-in-adults-with-advanced-solid-tumors-with-kras-mutations-100580305","NCT06835569","A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations","A Phase 1\u002F1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.\n* Unresectable or metastatic disease.\n* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol\n* Known condition that prohibits the ability to swallow or absorb an oral medication.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":199,"type":22},448,[201],"PHASE1","The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.",[204,31,205,206,207],"Cancer","NSCLC (Non-small Cell Lung Cancer)","CRC (Colorectal Cancer)","Advanced Solid Tumors",[209,210,211,212,213,214,215,216,217,39,218,219,220,221,222,223,224,225,226,227,228,229,230,231],"KRAS mutation","NSCLC","Non-small cell lung cancer","Colorectal cancer","Pancreatic ductal adenocarcinoma","Colorectal carcinoma","Pancreatic cancer","Pancreatic carcinoma","Solid tumors","Mutation","Metastatic","Advanced unresectable","Neoplasms","Neoplasms by Site","Carcinoma","Non-small cell lung carcinoma","Non-small cell lung neoplasm","Pancreatic neoplasm","Lung neoplasm","Colorectal neoplasm","Colon neoplasm","Mutant KRAS","KRAS amplification","2026-06-08",{"date":234,"type":48},"2026-06-10",{"date":236,"type":48},"2025-03-05",{"date":164,"type":22},{"name":239,"class":55},"Alterome Therapeutics, Inc.",12,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":190},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900","NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.",{"count":250,"type":22},174,[201],"This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[254,31,255,256,257,258,259,101,260],"Vulvar Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Hormone Receptor Positive Breast Carcinoma","2026-05-29",{"date":263,"type":48},"2026-06-02",{"date":265,"type":48},"2026-03-31",{"date":267,"type":22},"2030-06",{"name":269,"class":55},"Avacta Life Sciences Ltd",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":293,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":278,"type":22},665,[201],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[282,210,31,206,283,284,285,286,287,288,289,290,291,292],"Non-Small Cell Lung Cancer","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma","Solid Tumor, Adult",[294,295,296,297,210,298,30,299,300,301,302,303,304,305,306,307,308,309,310],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","CRC","Metastatic Cancer","Advanced Cancer","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel",{"date":263,"type":48},{"date":313,"type":48},"2025-03-31",{"date":315,"type":22},"2029-09",{"name":317,"class":55},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",17,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100525527","early-phase-1-prospective-screening-for-pancreatic-ductal-adenocarcinoma-in-high-risk-individuals-100525527","NCT06122896","Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals","Inclusion Criteria:\n\nParticipants must meet any of the following:\n\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in STK11, and age ≥30 years.\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND\n\n  • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic\u002Flikely pathogenic germline variant.\n* Individuals with pathogenic\u002Flikely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).\n* Individuals with familial pancreatic cancer including:\n\n  * Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in ≥3 first- and\u002For second-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant.\n* Individuals who are undergoing clinically recommended pancreatic cancer surveillance.\n\nExclusion Criteria:\n\n* Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.\n* Individuals with any active metastatic cancer.\n* Individuals who are unable to give informed consent.\n* Individuals who are under the age of 18 (infants, children, teenagers).\n* Individuals unable to tolerate Magnetic Resonance Imaging\u002FMagnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.\n* Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.",{"count":326,"type":22},5000,[328],"EARLY_PHASE1","The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.",[28,37,30,31,331],"Pancreatic Neoplasm",[28,37,30,31,331],"2026-05-27",{"date":261,"type":48},{"date":336,"type":48},"2023-11-21",{"date":338,"type":22},"2041-10-31",{"name":340,"class":167},"Dana-Farber Cancer Institute",2,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":350,"studyType":98,"phases":4,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":366},"100637149","the-canopy-cancer-collective-clinical-registry-protocol-100637149","NCT07605702","The Canopy Cancer Collective Clinical Registry Protocol","Inclusion Criteria:\n\nRetrospective Cohort:\n\n1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama\u002FNebraska 19; Puerto Rico 21).\n2. Must have histologically proven GI cancer seen at the site within the 20 years preceding activation, and are:\n\n   1. Deceased, or\n   2. Lost to follow-up ( \\>1 year lapse in contact since last visit).\n\nProspective Cohort:\n\n1. Must have reached the age of majority in the jurisdiction where enrolled (18 years; Alabama\u002FNebraska 19; Puerto Rico 21).\n2. Must have histologically proven Gastrointestinal (GI) cancer.\n3. Patient or legally authorized representative capable of understanding and willing to provide signed informed consent (assent if applicable).\n4. Patient\u002FLegally Authorized Representative (LAR) agrees to collection of clinical data and information available on archival tissue and subsequent excess specimens obtained as part of standard-of-care.\n\nExclusion Criteria:\n\nRetrospective Cohort:\n\n1\\. Cases in which patient's medical chart denotes restricted use of health information.\n\nProspective Cohort:\n\n1\\. Prisoners will not be approached for participation.",{"count":349,"type":22},100000,"2 Years","The Canopy Cancer Collective Clinical Registry Protocol Non-Interventional Data and Sample Collection Registry Protocol\n\nNumber of study sites 15 Study Design - Observational, registry Primary Objective To systematically collect and store comprehensive data on gastrointestinal cancer patients, encompassing both their past medical history and future clinical experiences, to address specific future research questions related to these malignancies, to establish and share best practices, and to support quality improvement initiatives focused on enhancing patient care and outcomes.\n\nSecondary Objective(s) 1. Leverage the collective to increase access to molecular profile and biomarker (ctDNA) matched clinical trials across the treatment trajectory.\n\n2\\. Use real world data and patient reported outcomes to improve patient care throughout the treatment trajectory.\n\nResearch Procedure(s) Collection of clinical and outcome data and cataloging and facilitating access to physical biological specimens and their associated data for future research purposes.\n\nDrugs\u002FDevices used on Study None Study Population Patients with diagnosis of gastrointestinal (GI) cancers who seek care at one of the canopy centers and\u002For their affiliates Sample Size Up to 30000 patients in the prospective component\n\nUp to 70000 subjects will be enrolled on the retrospective component Study Duration for Individual Participants Anticipated to be at least 1 year Study Specific Abbreviations AE: Adverse Event CEC: Clinical Events Committee CT: Computed Tomography iCCA: Intrahepatic cholangiocarcinoma MRI: Magnetic Resonance Imaging OS: Overall Survival PFS: Progression Free Survival",[353,28,101,354,31,30,355],"Gastrointestinal Neoplasms","GI Cancers","GI Cancer","2026-05-18",{"date":358,"type":48},"2026-05-26",{"date":360,"type":22},"2026-05",{"date":362,"type":22},"2038-05",{"name":364,"class":365},"Canopy Cancer Collective, LLC","NETWORK",10,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":168},"100611644","volatile-organic-compound-assessment-in-pancreatic-ductal-adenocarcinoma-vapor2-100611644","NCT07243262","Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR2)","Inclusion Criteria:\n\n* Adult participants ≥ 18 years old\n* Referral from primary care according to the urgent suspected cancer referral guidelines for potential underlying pancreatic cancer, or referral directly to a pancreatic cancer multidisciplinary team meeting\n\nExclusion Criteria:\n\n* Previous pancreatic resection\n* History of another cancer (other than non-melanoma skin cancers) within three years\n* Pregnant participants (pregnancy status to be confirmed verbally with the participant)\n* Participants with co-morbidities preventing breath collection\n* Unable or unwilling to provide informed consent",{"count":374,"type":22},6079,"The investigators are developing a non-invasive breath test to help us detect pancreatic cancer earlier. The test detects small molecules called volatile organic compounds that are made by pancreatic cancers.\n\nPancreatic cancer is a rare disease but patients are often diagnosed at a late stage because their symptoms are the same as those of many common illnesses. This makes it hard for doctors to know which patients need to be tested for pancreatic cancer. If the investigators find pancreatic cancer at a late stage, it reduces the number of treatment choices for patients.\n\nOur test could be offered to patients who are experiencing vague symptoms, which might be caused either by pancreatic cancer or a common illness. This test could help doctors to identify which of those patients may have pancreatic cancer, and ensure they get referred for specialised pancreatic cancer tests. The investigators hope that this will allow us to diagnose pancreatic cancer earlier, increasing treatment choices for patients and improving survival from pancreatic cancer.\n\nThe investigators have previously conducted a study (VAPOR1) which collected breath samples from people with and without pancreatic cancer. When the investigators analysed these samples, they found that there is a difference in the volatile organic compounds breathed out by people who have pancreatic cancer compared to those that do not. The investigators used these 'markers' to develop a breath test to diagnose pancreatic cancer. In VAPOR2, the investigators will study our breath test in a much larger group of patients who have been referred for further investigations for potential underlying pancreatic cancer to see how accurately it can pick up the small percentage of people who have pancreatic cancer.",[28,31],[378,379,380,381,382],"Volatile organic compounds (VOCs)","Breath analysis","Volatolomics","Validation","Early detection of cancer","2026-05-15",{"date":385,"type":48},"2026-05-19",{"date":387,"type":48},"2025-10-21",{"date":389,"type":22},"2028-08-01",{"name":391,"class":167},"Imperial College London",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":168},"100495118","volatile-organic-compound-assessment-in-pancreatic-ductal-adenocarcinoma-100495118","NCT05727020","Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma","Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR 1 \u002F BIORESOURCE)","VAPOR","Inclusion Criteria:\n\n* Males and females\n* Adult patients ≥ 18 years old\n* VAPOR 1: patients with either a) Histologically confirmed PDAC\\*; b) New-onset diabetes mellitus or chronic pancreatitis; or c) Non-specific gastrointestinal symptoms, but a radiologically-normal pancreas\n* VAPOR Bioresource: patients undergoing pancreatic resection for a) Histologically confirmed PDAC\\*; or b) Benign pancreatic disorders e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis\n\nNote: \\*Patients undergoing surgery for suspected PDAC (without pre-operative histological confirmation) may be recruited assuming PDAC is confirmed within the resected specimen.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their PDAC\n* History of another cancer within the previous five years\n* Previous upper gastrointestinal surgery\n* Patients who are unable to provide a breath sample\n* Pregnant women\n* Patients unable to provide informed written consent\n* VAPOR 1: Patients with active infection, receiving immunosuppressive medications or antibiotics within the preceding eight weeks\n* VAPOR Bioresource: Patients receiving immunosuppressive medications within the preceding eight weeks",{"count":401,"type":22},1005,"Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all. Jaundice, weight loss and pain are 'red flag' symptoms of pancreatic cancer that are linked to incurable disease. At the moment only patients with 'red flag' symptoms are urgently referred for diagnostic testing to find out if they have the cancer. As a result, late diagnosis is a common feature of pancreatic cancer. This leads to limited treatment options being available to patients by the time they are diagnosed, and ultimately results in poor survival rates.\n\nThere is a clear need to improve earlier detection of pancreatic cancer so that patients with pancreatic cancer can be identified earlier and faster, enabling them to start treatment more quickly.\n\nThe study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that may be altered by pancreatic cancers. For patients with non-specific symptoms, this test would help general practitioners (GPs) to identify those patients that may indeed have an underlying pancreatic cancer, who would benefit from referral for specialised pancreatic cancer tests.",[31,28],[378,379,380,405,406,407,408,409],"Metabonomics \u002F Lipidomics","Transcriptomics","Microbiome Analysis","Organoids","Immune profiling",{"date":356,"type":48},{"date":412,"type":48},"2022-12-15",{"date":414,"type":22},"2028-08",{"name":391,"class":167},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":427,"conditions":428,"keywords":432,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"100586992","phase-1-study-to-evaluate-the-safety-tolerability--efficacy-of-tng462-in-combination-in-pdac--nsclc-patients-100586992","NCT06922591","Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients","A Phase 1\u002F2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation","Inclusion Criteria:\n\n1. Is ≥18 years of age at the time of signature of the main study ICF.\n2. Has an ECOG PS of 0 or 1.\n3. Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene\n4. Arms A and B only: Has a tumor with a RAS mutation\n5. Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC\n6. Has received prior standard therapy\n7. Arms A and B only: Must not have received prior RAS-targeted therapy\n8. Has evidence of measurable disease based on RECIST v1.1.\n9. Adequate organ function\n10. Must be able to swallow tablets.\n11. Negative pregnancy test at screening\n12. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor\n2. Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805\n3. Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine\u002Fnab-paclitaxel (Arm D) or their excipients\n4. Has uncontrolled intercurrent illness that will limit compliance with the study requirements.\n5. Has an active infection requiring systemic therapy.\n6. Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.\n7. Has impairment of GI function or disease that may significantly alter the absorption of the oral medications\n8. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms\n9. Has current active liver disease from any cause\n10. Is known to be HIV positive, unless all the following criteria are met:\n\n    1. CD4+ count ≥300\u002FµL.\n    2. Undetectable viral load.\n    3. Receiving highly active antiretroviral therapy\n11. Has clinically relevant cardiovascular disease\n12. History of or presence of active interstitial lung disease\n13. Is a female patient who is pregnant or lactating\n14. Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions.\n15. Has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion may affect the safety of the patient or impair the ability to assess study results",{"count":424,"type":22},183,[201,426],"PHASE2","TNG462-C102 is a Phase 1\u002F2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine\u002Fnab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.",[30,31,210,43,429,430,29,431],"MTAP Deletion","Lung Cancer","Thoracic Cancer",[433,434,435,436,437,438,439],"PRMT5 inhibitor","RAS G12D","Multi RAS","RMC-9805","RMC-6236","Thoracic","Targeted therapy","2026-05-12",{"date":442,"type":48},"2026-05-14",{"date":444,"type":48},"2025-05-31",{"date":446,"type":22},"2027-12",{"name":448,"class":55},"Tango Therapeutics, Inc.",18,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":457,"phases":4,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":471,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":475,"locationsCount":4},"100637017","expanded-access-program-for-daraxonrasib-rmc-6236-in-previously-treated-metastatic-pancreatic-adenocarcinoma-100637017","NCT07573215","Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma","Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed PDAC with metastatic disease.\n* Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.\n* At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.\n* Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.\n* Adequate bone marrow, renal, hepatic, and coagulation functions.\n* Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.\n* Able to take oral medications\n\nExclusion Criteria:\n\n* History of known central nervous system metastatic disease.\n* Concurrent systemic anticancer therapy.\n* Significant cardiovascular disease.\n* Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).\n* Active uncontrolled systemic infection.\n* Major surgery within 28 days before enrollment.\n* Additional inclusion and exclusion criteria may apply.","EXPANDED_ACCESS","This Expanded Access Program (EAP) is intended to provide daraxonrasib to eligible adult patients with previously treated metastatic pancreatic adenocarcinoma, who have no comparable or satisfactory alternative therapy and are unable to participate in an ongoing daraxonrasib clinical trial.",[30,31,460,28,29,33,34,35],"Metastatic Pancreas Adenocarcinoma",[462,463,464,437,465,466,467,468,469,215,38,39,29,33,35,34,470],"Expanded Access Program (EAP)","EAP","Daraxonrasib","RMC-0706236","Metastatic pancreatic adenocarcinoma","Pancreatic ductal adenocarcinoma (PDAC)","RAS(ON) inhibitor","Unmet medical need","Compassionate Use","AVAILABLE","2026-05-01",{"date":474,"type":48},"2026-05-07",{"name":54,"class":55},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":168},"100596618","pdac-pathways-a-digital-informational-and-supportive-care-app-for-patients-initiating-neoadjuvant-therapy-for-pancreatic-ductal-adenocarcinoma-100596618","NCT07047807","PDAC-PATHWAYS: A Digital Informational and Supportive Care App for Patients Initiating Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma","PDAC-PATHWAYS","Inclusion Criteria:\n\n* Age≥18 years\n* Within 8 weeks of a documented decision to pursue neoadjuvant therapy for newly diagnosed, non-metastatic PDAC\n* Able to comprehend and speak English\n\nExclusion Criteria:\n\n* Comorbid health condition that would interfere with study participation, as identified by the cancer care team",{"count":484,"type":22},50,[154],"This study aims to refine and pilot test PDAC-PATHWAYS, a digital informational and supportive care app for patients who are initiating neoadjuvant therapy for pancreatic ductal adenocarcinoma (PDAC).",[31],"2026-04-15",{"date":490,"type":48},"2026-04-20",{"date":492,"type":48},"2025-10-06",{"date":494,"type":22},"2027-08",{"name":496,"class":167},"Massachusetts General Hospital",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":341},"100567331","functional-personalised-and-integrated-profiling-of-biopsied-pancreatic-tumours-cancerprofile-by-fnb-100567331","NCT06666803","Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours (CancerProfile by FNB)","Functional, Personalised and Integrated Profiling of Biopsied Pancreatic Tumours","Inclusion Criteria:\n\n* Adult patient over 18 years of age.\n* Patient undergoing echo-endoscopy with certainty\u002Fsuspicion of fine needle biopsy (EUS-FNB).\n* Suspicion of pancreatic lesion\n* Patient able to receive and understand information relating to the research protocol and to give consent.\n* Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n* Patient not programmed for endoscopy with certainty\u002Fsuspicion of fine needle biopsy (EUS-FNB).\n* Patient undergoing echo-endoscopy and presenting a high risk that may prevent EUS-FNB.\n* Patient with degenerated Intraductal papillary mucinous neoplasm (IPMN)\n* Patient with acute pancreatitis within 4 weeks prior to EUS\n* Pregnant or breast-feeding patient\n* Patient under court protection.\n* Patient under guardianship or curatorship.\n* Patient in a situation of social vulnerability.\n* Patient under legal protection or unable to express his\u002Fher opposition.",{"count":505,"type":22},60,[154],"Pancreatic ductal adenocarcinoma (PDAC) has the poorest prognosis of all digestive cancers due to lack of early diagnosis and limited response to treatment. Patient-derived organoid technology has become a mainstay of precision oncology, enabling personalised functional characterisation of tumours (e.g. treatment evaluation and drug screening). Initial research carried out as part of the Cancer Profile project has produced the first organoids from resected PDAC parts.\n\nOnly 15-20% of patients can benefit from surgical resection, which remains the only curative treatment. In contrast, most patients with PDAC undergo diagnostic fine-needle biopsies (FNB) using an echo-endoscopic procedure (EUS). The next step is therefore the reliable generation of organoids from limited quantities of biopsy material obtained by 'EUS-FNB'.\n\nThe aim of the study presented here is to validate these organoids on the basis of the following characteristics: (i) morphological and proliferative characteristics, (ii) recapitulation of the genetic characteristics of the original tumour, (iii) expression of tumour markers.",[31],[30,510,511,512,513,514],"EUS","FNB","PDO","organoid","OCT","2026-04-13",{"date":517,"type":48},"2026-04-16",{"date":519,"type":48},"2025-01-27",{"date":521,"type":22},"2027-02",{"name":523,"class":167},"IHU Strasbourg",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":150,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":531,"studyType":98,"phases":4,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":168},"100527704","a-prospective-registry-for-patients-at-high-risk-for-pancreatic-cancer-100527704","NCT06151223","A Prospective Registry for Patients at High-Risk for Pancreatic Cancer","Inclusion Criteria:\n\n* Age ≥ 18 year\n* Able to provide written informed consent\n* Meets criteria as a High-Risk Individual as defined by protocol\n\nExclusion Criteria:\n\n* Individual who has a personal history of pancreatic ductal adenocarcinoma (PDAC)\n* History of total pancreatectomy",{"count":326,"type":22},"10 Years","This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.",[28,37,30,31],"2026-03-06",{"date":536,"type":48},"2026-03-10",{"date":538,"type":48},"2021-07-13",{"date":540,"type":22},"2031-07-31",{"name":542,"class":167},"Mayo Clinic",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":566,"locationsCount":568},"100431646","phase-1-study-of-tj033721-givastomig-in-subjects-with-advanced-or-metastatic-solid-tumors-100431646","NCT04900818","Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors","A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.\n\nPart 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;\n\nPart 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;\n\nPart 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function\n* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)\n\nFor dose expansion and Part 2, Part 3, Part 4 Combination subjects:\n\n• Must have CLDN18.2-positive tumor expression\n\nExclusion Criteria\n\n* Prior exposure to CLDN18.2 -targeted therapy\n* Prior exposure to 4-1BB agonists\n* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ\n* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides\n* Unstable\u002Factive ulcer or digestive tract bleeding within 6 weeks\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe\u002Funstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months\n* Diagnosis of immunodeficiency such as known active HIV\n* Any active infection requiring parenteral treatment\n\nFor Part 2, 3, 4 Combination subjects:\n\n• Prior treatment with anti-PD-1 or PD-L1 agent",{"count":551,"type":22},330,[201],"This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.",[555,300,299,556,557,558,31,559],"Solid Tumor","Gastric Cancer","Gastroesophageal Junction Carcinoma","Esophageal Adenocarcinoma","Biliary Tract Cancer (BTC)","2026-03-03",{"date":562,"type":48},"2026-03-05",{"date":564,"type":48},"2021-06-29",{"date":446,"type":22},{"name":567,"class":55},"I-Mab Biopharma US Limited",21,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100596713","phase-1-a-clinical-trial-to-evaluate-edv-nanocell-therapy-with-gemcitabine-and-nab-paclitaxel-in-pancreatic-cancer-100596713","NCT07049055","A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in Pancreatic Cancer","A Phase I\u002FIIa Randomized Clinical Trial to Evaluate the Efficacy of EGFR-targeted, PNU-159682-packaged Nanocells & Glycolipid-Packaged Nanocells in Combination With Gemcitabine & Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma","Carolyn-USA","Inclusion Criteria:\n\n* Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.\n* Male or Female greater than or equal to 18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.\n* Life expectancy ≥ 3 months in the opinion of the Investigator.\n* Measurable disease as per iRECIST criteria.\n* Subjects must have tumors that express EGFR.\n* Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+\u002F- 15 days) after end of therapy.\n* No more than one line of prior systemic therapy for metastatic PDAC allowed.\n* Albumin level \\> 3.0 g\u002Fdl\n* Adequate hematological function.\n* Adequate renal function.\n* Adequate hepatic function.\n* Adequate cardiac function with LVEF ≥ 50% at baseline.\n* Reproductive criteria as follows:\n* Female subjects who are of non-reproductive potential\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.\n* Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.\n* Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.\n* All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.\n* The subject (or subject's legally authorized representative) has provided voluntary signed informed consent.\n* According to the investigator's assessment, subject will be able to comply with the study protocol.\n\nExclusion Criteria:\n\n* Subjects currently receiving any other investigational agent.\n* Unresolved (≥ Grade 1) non-hematological adverse events from prior anti-cancer therapy that is not controlled on maximal supportive therapy.\n* Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.\n* History of leptomeningeal or brain\u002FCNS metastases.\n* Ongoing treatment for other malignancies (hormone therapy acceptable).\n* Patient may not have a history of malignancy other than PDAC within two years prior to screening except in circumstances where the risk of recurrence, metastasis or death in 5-years is \\\u003C10%.\n* Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids that requires active titration of insulin.\n* Subject has experienced a history of uncontrolled coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association \\> Class II)\n* Uncontrolled hypertension (systolic \\> 180 mmHg or diastolic \\> 100 mmHg) within two weeks.\n* Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy within the last four weeks.\n* Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females).\n* Uncontrolled HIV infection. Patients without a prior diagnosis of HIV infection will undergo HIV testing unless not permitted to do so under local regulations. Patients with known HIV who have controlled infection (viral load undetectable and a CD4 count \\>350 either spontaneously or on a stable antiviral regimen) are permitted.\n* Uncontrolled Hepatitis B virus (HBV) infection (chronic or acute).\n* Uncontrolled Hepatitis C virus (HCV) infection.\n* Uncontrolled arterial or venous thrombosis.\n* Active or uncontrolled severe infection.\n* Uncontrolled hypercalcemia (\\>2.6mmol\u002FL or \\>10.3mg\u002FdL) or symptomatic hypercalcemia requiring continued treatment for hypercalcemia.\n* Received the following procedures within 21 days to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:\n* other investigational therapy\n* radiotherapy\n* any major surgery.\n* Prior other therapies or procedures prior to receiving their first dose:\n* QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging, considered as substitutes.\n* Known allergy\u002Fhypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).\n* Female who is pregnant or breastfeeding.\n* Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator's knowledge.\n* Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and\u002For to comply with all required study procedures.\n* History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":578,"type":22},144,[201,426],"The purpose of this study is to evaluate the safety and tolerability and overall survival (OS) of E-EDV-D682\u002FGC in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone in participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on therapy.",[582,31],"Pancreatic Cancer, Metastatic",[30,584,585,28,586,587,588,589,590],"Molecular Targeted Therapy","Drug Delivery Systems","Epidermal Growth Factor Receptor","Bispecific Antibodies","Antineoplastic Agents","Immunotherapy","Disease Progression","2026-02-26",{"date":593,"type":48},"2026-02-27",{"date":595,"type":48},"2026-01-12",{"date":597,"type":22},"2028-09",{"name":599,"class":55},"Engeneic Pty Limited",4,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":4},"100618848","phase-3-a-phase-iii-randomized-clinical-trial-of-gnp-combined-with-sbrt-and-serplulimab-versus-gnp-as-first-line-treatment-for-patients-with-recurrent-or-metastatic-pancreatic-cancer-wgog-pan-006icsbr-2-100618848","NCT07336953","A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006\u002FICSBR-2)","A Randomized, Controlled, Phase III Study of Gemcitabine and Nab-paclitaxel (GnP) Combined With Stereotactic Body Radiation Therapy (SBRT) and Serplulimab Versus GnP as First-Line Therapy in Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006\u002FICSBR-2)","Inclusion Criteria：\n\n1. Patients with pathologically confirmed metastatic pancreatic cancer who are inoperable, with diagnosis based on a comprehensive assessment of pathology and imaging studies (CT or MRI);\n2. Patients who have not previously received any systemic anticancer therapy (including chemotherapy, radiotherapy, or other investigational treatments), or who underwent radical pancreatic cancer resection with standard neoadjuvant or adjuvant chemotherapy and experienced recurrence or progression more than 6 months after the last adjuvant chemotherapy;\n3. Age 18-75 years, no gender restriction;\n4. ECOG performance status 0-2;\n5. At least one measurable tumor lesion: ≥10 mm in longest diameter on spiral CT, ≥15 mm in shortest diameter for lymph nodes; ≥20 mm in maximum diameter on conventional CT or physical examination;\n6. No more than 10 metastatic lesions throughout the body excluding the primary tumor, with the largest metastatic lesion ≤10 cm in diameter; and at least one lesion deemed suitable for radiotherapy based on imaging assessment;\n7. Normal major organ function (bone marrow, hepatic, renal, coagulation, etc.):\n\n   Bone marrow function (no transfusion within 14 days prior to screening): WBC ≥3.0×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥80×10⁹\u002FL, Hb ≥90g\u002FL;\n   * Liver function: ALT and AST ≤3× upper limit of normal (ULN), TBIL ≤1.5×ULN (if liver metastases present, ALT and AST ≤5×ULN, TBIL ≤2×ULN acceptable for liver-metastatic subjects); Child-Pugh score ≤7 points;\n   * Renal function: Serum Cr ≤1.5 ULN, proteinuria ≤2+ or ≤2 g\u002F24h, estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m² (calculated using Cockcroft-Gault formula);\n   * Coagulation function: PT, APTT, and INR ≤1.5×ULN. Patients receiving fixed anticoagulant therapy for at least 30 days prior to study drug administration may have PT or INR \\>1.5×ULN if deemed suitable for the study by the investigator, provided adequate justification is provided;\n   * Serum sodium, potassium, calcium, and magnesium levels ≤ Grade 1 (NCI-CTCAE version 5.0);\n   * Electrocardiogram (ECG) showing QTc interval ≤ 480 ms;\n8. Expected survival ≥3 months;\n9. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must use at least one medically acceptable form of contraception (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for at least 6 months after the last dose of chemotherapy or PD-1 inhibitor;\n10. Ability to understand the protocol and comply with its requirements prior to any study-related procedures; full comprehension and voluntary participation in the study, with written informed consent provided.\n\nExclusion Criteria:\n\n1. Known allergy to any investigational drug;\n2. Subjects with known or suspected central nervous system (CNS) metastases, i.e., those exhibiting signs or symptoms suggestive of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;\n3. History of other malignancies within 5 years prior to first administration of the study drug (excluding adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ);\n4. Prior treatment with any immune checkpoint inhibitor (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);\n5. Requirement for concomitant antitumor therapy outside the study regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, other immunotherapy regimens, radiotherapy, or antitumor Chinese herbal medicine;\n6. Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 7 days prior to the first study dose;\n7. Subjects requiring systemic treatment with corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 14 days prior to the first study drug administration; inhaled or topical steroids are permitted in the absence of active autoimmune disease, and adrenal corticosteroid replacement therapy at a dose ≤10 mg\u002Fday prednisone equivalent is allowed;\n8. Recipients of antitumor vaccines or live vaccines within 4 weeks prior to the first study drug administration;\n9. Major surgery within 28 days prior to the first study drug administration, defined as surgery requiring at least 3 weeks of postoperative recovery before study treatment initiation. Tumor needle biopsies or lymph node excision biopsies are permitted;\n10. Requirement for concomitant medications during the trial that may affect the metabolism of the study drug;\n11. Presence of uncontrollable third-space effusions (e.g., pleural effusion, pericardial effusion, or ascites);\n12. Concurrent uncontrolled cardiovascular or cerebrovascular clinical symptoms or diseases, including but not limited to: NYHA Class II or higher heart failure, unstable angina, myocardial infarction or cerebral infarction within the past 6 months, clinically significant supraventricular or ventricular arrhythmias that remain uncontrolled despite clinical intervention;\n13. Uncontrolled hypertension (defined as systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite treatment);\n14. History of severe hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major bleeding from tumors;\n15. Severe infection (CTCAE ≥ Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; baseline chest imaging demonstrating active pulmonary inflammation with clinically relevant symptoms or signs; Symptoms or signs of infection within 2 weeks prior to the first dose of study drug, requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;\n16. Known active autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Exceptions include: vitiligo or childhood asthma\u002Fallergies that have resolved without intervention in adulthood; autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement therapy; type 1 diabetes treated with stable doses of insulin. Subjects in stable condition who do not require systemic immunosuppressive therapy (including corticosteroids) are eligible for enrollment;\n17. History of immunodeficiency, including HIV antibody positivity, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;\n18. Active pulmonary tuberculosis infection identified by medical history or CT scan, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment;\n19. Subjects HBsAg-positive and\u002For HBcAb-positive with HBV-DNA ≥500 IU\u002FmL or 2500 copies\u002FmL at baseline. For values exceeding this threshold, enrollment is permitted only if subjects first undergo antiviral therapy to achieve normalization for at least 2 weeks and continue antiviral therapy throughout the study period. For subjects requiring prior antiviral therapy or currently receiving it at screening, inclusion requires continued antiviral treatment throughout the study period, even if HBV-DNA meets inclusion criteria. Hepatitis C (HCV antibody positive and HCV-RNA positive);\n20. Concomitant medications deemed by the investigator to potentially affect the metabolism of the study drug during the trial period, such as strong CYP3A4 inhibitors or inducers, drugs primarily metabolized via CYP3A4, 2C8, 2C9, 2C19, or 2D6, and drugs with a narrow therapeutic index;\n21. Pregnant or lactating women, or female subjects of childbearing potential unwilling to use contraception during the trial and for 3 months after the last dose;\n22. Subjects with other factors deemed by the investigator to potentially necessitate forced discontinuation of the study, such as: - Concurrent treatment for other serious illnesses (including psychiatric disorders) - Severely abnormal laboratory values - Family or social factors that may compromise subject safety or data collection - Subjects deemed unsuitable for enrollment by the investigator.","75 Years",{"count":610,"type":22},198,[25],"This Phase III randomized trial, evaluates whether adding targeted radiation (SBRT) and an immunotherapy drug (Serplulimab) to standard chemotherapy (GnP) can extend the lives of patients with advanced pancreatic cancer.",[31],"2026-01-04",{"date":616,"type":48},"2026-01-13",{"date":618,"type":22},"2026-02",{"date":620,"type":22},"2028-07",{"name":622,"class":167},"West China Hospital",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":634,"conditions":635,"keywords":644,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":658,"leadSponsor":660,"locationsCount":168},"100613159","phase-4-preventing-postoperative-complications-in-patients-undergoing-high-risk-pancreatoduodenectomy-with-a-bundle-approach-including-hydrocortisone-octreotide-and-the-teres-ligament-patch-panenca-100613159","NCT07262957","Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)","Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA): an International Randomized Controlled Multicenter Trial","PANENCA","Inclusion Criteria:\n\n* Elective pancreatoduodenectomy for any indication (both minimally invasive and open)\n* Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\\*\n* 18 years of age or older\n* Signature of informed consent\n* In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications, warnings, and precautions as listed in the respective SmPCs\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or current breastfeeding\n* Known allergy or hypersensitivity to hydrocortisone or octreotide\n* Systemic fungal infection\n* Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))\n\n  * Inhibitors must be discontinued ≥7 days before randomization\n  * Inducers must be discontinued ≥28 days before randomization",{"count":152,"type":22},[633],"PHASE4","The PANENCA trial aims to reduce postoperative complications in patients undergoing pancreatoduodenectomy (also known as a Whipple procedure), a complex surgical operation performed to remove tumors located in or near the head of the pancreas. One of the most frequent and serious complications after this surgery is postoperative pancreatic fistula (POPF), a leakage of pancreatic fluid from the surgical connection. POPF can lead to intra-abdominal infection, bleeding, and inflammation, often resulting in delayed recovery and postponement of subsequent oncological treatment. In severe cases, these complications may be life-threatening.\n\nPatients with a small main pancreatic duct (3 millimeters or less) are known to have a substantially higher risk of developing POPF. Previous studies have shown that several existing interventions may reduce the risk or severity of these complications. These include hydrocortisone, a medication that suppresses postoperative inflammation; octreotide, a medication that reduces the production of pancreatic secretions; and a surgical technique known as the ligamentum teres hepatis patch, which uses the patient's own tissue to protect nearby blood vessels in the event of a pancreatic leak.\n\nBecause the development of pancreatic fistulas is multifactorial, the investigators hypothesize that a combined approach targeting different underlying mechanisms may provide a complementary and more effective protective effect than any single intervention alone. The PANENCA trial therefore evaluates whether the combined use of hydrocortisone, octreotide, and the ligamentum teres patch can reduce the rate of major postoperative complications after pancreatoduodenectomy.\n\nPatients participating in the study are randomly assigned to receive either the combination treatment in addition to standard perioperative care or standard perioperative care alone. The study medications are administered only during the first postoperative days, and the surgical patch is applied during the operation itself. No additional tests, monitoring procedures, or hospital visits are required beyond routine clinical care.\n\nThis international, multicenter randomized trial includes patients at high risk for POPF who are undergoing pancreatoduodenectomy. The primary objective is to determine whether the combination treatment reduces the incidence of major postoperative complications. If proven effective, this bundle approach may be implemented more consistently across participating countries and incorporated into international clinical guidelines for pancreatic surgery.",[636,637,158,638,639,31,640,641,642,643],"Pancreas Head Cancer","Pancreas Adenocarcinoma","Cholangio Carcinoma","Ampulla of Vater Adenocarcinoma","Duodenal Carcinoma","Mucinous Cystic Neoplasm","Neuro Endocrine Tumours","Pancreatitis",[645,646,647,648,649,650,651,652,653],"Whipple","Pancreatoduodenectomy","POPF","Major complications","Fistula","ISGPS","Hydrocortisone","Octreotide","Ligament teres patch","2025-12-16",{"date":656,"type":48},"2025-12-22",{"date":162,"type":48},{"date":659,"type":22},"2027-12-01",{"name":661,"class":167},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":670,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":341},"100449420","monitoring-and-managing-glucose-levels-in-people-with-pancreatic-cancer-100449420","NCT05132244","Monitoring and Managing Glucose Levels in People With Pancreatic Cancer","Pancreatic Cancer Glucose Assessment and Regulation Study","PEGASUS","Inclusion Criteria:\n\n* Histological\u002Fcytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).\n* Planned to undergo first-line systemic therapy with FOLFIRINOX.\n* Age greater than or equal to 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate bone marrow and organ function as defined by the following laboratory values:\n\n  1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\\^9\u002FL.\n  2. Platelet count greater than or equal to 75 x 10\\^9\u002FL.\n  3. Hemoglobin greater than or equal to 9.0 g\u002FdL.\n  4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml\u002Fmin.\n  5. Creatinine clearance greater than or equal to 40 mL\u002Fmin using Cockcroft-Gault formula.\n  6. Potassium within normal limits, or corrected with supplements.\n  7. International normalized ratio (INR) less than or equal to 1.5.\n  8. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).\n  9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).\n* Able to understand and voluntarily sign the informed consent form.\n* Able to comply with the study visit schedule and other protocol requirements.\n* Able to swallow oral medications and has no contraindications to subcutaneous insulin injections.\n* Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.\n* Life expectancy of more than 90 days as judged by the study doctor.\n\nExclusion Criteria:\n\n* Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.\n* Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.\n* Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).\n* Not fit for combination chemotherapy as judged by the study doctor.\n* Presence of brain metastases.\n* Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.\n* Known diagnosis of type II diabetes and already followed by Endocrinologist.\n* Female participants with a positive pregnancy test.\n* Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.\n* Unable to comply with study assessments and follow-up.",{"count":484,"type":22},[154],"This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer.\n\nThis is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol\u002FL; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol\u002FL, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors.\n\nAfter 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and\u002For medical oncologist.",[28,31,674],"Hyperglycemia",[676,677,678,679,680,681,682,683],"FOLFIRINOX","Continuous Glucose Monitor","Feasibility","Glycemic management","Endocrinologist","Intensive glucose intervention","Pilot","Glucose control","2025-09-17",{"date":686,"type":48},"2025-09-22",{"date":688,"type":48},"2024-04-16",{"date":690,"type":22},"2027-04",{"name":692,"class":167},"British Columbia Cancer Agency",{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":697,"acronym":698,"eligibilityCriteria":699,"healthyVolunteers":150,"sex":18,"minAge":700,"maxAge":4,"enrollmentInfo":701,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":703,"conditions":704,"keywords":707,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":713,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":721},"100601941","artificial-intelligence-powered-low-dose-computed-tomography-for-screening-of-pancreatic-cancer-100601941","NCT07117045","Artificial Intelligence-powered Low-Dose Computed Tomography for Screening of Pancreatic Cancer","AI-LDCT-PC","Inclusion Criteria:\n\n1. Age 50 years and above.\n2. Voluntary signing of informed consent.\n3. Completion of LDCT examination.\n\nExclusion Criteria:\n\n1. Previous history of pancreatic cancer.\n2. Abdominal inflammation or diagnosis of acute pancreatitis within 6 months.\n3. Poor image quality due to ascites, pancreatic trauma, thoracic\u002Fabdominal surgery, radiotherapy or chemotherapy.\n4. Research subjects unable to complete follow-up due to physical or other reasons.","50 Years",{"count":702,"type":22},400000,"Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis, with early diagnosis crucial for improving survival. Due to the absence of effective screening methods, most patients are diagnosed at advanced stages. The population undergoing low-dose computed tomography (LDCT) screening significantly overlaps with those at high risk for PDAC; however, traditional imaging methods have limited sensitivity for detecting pancreatic lesions. This study utilizes the Pancreatic Cancer Detection with Artificial Intelligence (PANDA) system to enhance LDCT for pancreatic cancer screening in a prospective, multicenter, observational cohort. PANDA will analyze LDCT images, followed by a multidisciplinary team (MDT) reassessment of abnormal interpretations. Based on MDT evaluation, individuals will be recalled for further examination, placed under a personalized follow-up plan, or monitored for at least one year. The primary outcomes include pancreatic cancer detection rate, positive predictive value, consensus rate, and recall rate, while secondary outcomes focus on early-stage cancers, resectable tumors, and safety indicators such as false positive rates and unnecessary procedures. This study aims to assess the effectiveness and safety of AI-assisted LDCT for PDAC detection, providing a practical solution for improving public health and enhancing early diagnostic capabilities.",[28,705,706,31,641],"Intraductal Papillary Mucinous Neoplasm","High-grade Pancreatic Intraepithelial Neoplasia",[708,709,28,710,711],"Screening","Early Diagnosis","Artificial Intelligence","Computed Tomography","2025-08-05",{"date":714,"type":48},"2025-08-12",{"date":716,"type":22},"2025-08-15",{"date":718,"type":22},"2032-12-30",{"name":720,"class":167},"Changhai Hospital",5,{"id":723,"slug":724,"hasResults":12,"nctId":725,"briefTitle":726,"officialTitle":727,"acronym":728,"eligibilityCriteria":729,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":730,"targetDuration":4,"studyType":23,"phases":732,"briefSummary":733,"conditions":734,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":240},"100595128","phase-2-panoramix--optimizing-1st-line-nalirifox-and-exploring-microbiotas-role-in-2nd-line-pancreatic-cancer-treatment-100595128","NCT07028424","PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment","Pancreatic Cancer First-line NALIRIFOX Optimization With 5-FU Maintenance and Role of Antibiotics and Microbiota Exploration in Second-line Treatment - A Non-comparative, Randomized Phase II PANORAMIX GERCOR G-116 PRODIGE 105 Study.","PANORAMIX","Inclusion Criteria:\n\nOverlapping inclusion criteria for STEP 1 AND STEP 2\n\n1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations (only after interim analysis at Step 2 for patients who were not randomized in first randomization \\[R1\\]),\n2. Age ≥18 years old. STEP 1: The patient over 75 years of age is eligible only if the patient's G8 score (G8 questionnaire) is \\> 14,\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1,\n4. Histologically or cytologically proven PDAC,\n5. ≥1 measurable lesion according to RECIST v 1.1 (Computed tomography thorax-abdomen-pelvis \\[TAP-CT\\] scan ≤ 4 weeks), Note: abdominal magnetic resonance imaging (MRI) is allowed (e.g., in case of contra-indication to CT scan contrast injection) provided that this imaging modality is used consistently throughout the tumor evaluations,\n6. Availability of archival tissue samples for exploratory research. Step 2: can be the same as in Step 1 or it can be newly obtained sample,\n7. Adequate organ function, obtained within 21 days prior to randomization of study treatment, as defined by the following:\n\n   * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN; ≤ 5 x ULN in case of liver metastases) - STEP 2, if paclitaxel administration,\n   * Total serum bilirubin \\\u003C 1.5 x ULN (STEP 2, if paclitaxel administration),\n   * Serum albumin ≥ 28 g\u002FL,\n   * Hemoglobin ≥ 9.0 g\u002Fdl,\n   * Absolute neutrophil count (ANC) ≥ 2 x 10\\^9L,\n   * Platelets - STEP 1: ≥ 150 x 10\\^9L; STEP 2: ≥ 100 x 10\\^9L,\n   * Creatinine clearance ≥ 50 mL\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\]),\n8. Evidence of post-menopausal status or negative serum pregnancy test within 7 days before starting study treatment for female pre- menopausal patients. Women of childbearing potential (WOCBP) should use effective contraception during study treatment and: 1 month (paclitaxel), 6 months (5FU, LV), 7 months (NAL-IRI), 15 months (oxaliplatin), and 6 months (gemcitabine+\u002F-paclitaxel and ciprofloxacin\u002Fplacebo) after the patient's last dose of treatment. Males who are fertile should use effective contraception during study treatment and 4 months (NAL-IRI), 6 months (5-FU, LV), 12 months (oxaliplatin), and 6 months (gemcitabine+\u002F-paclitaxel and ciprofloxacin\u002Fplacebo) after the patient's last dose of treatment.\n9. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up,\n10. Registration in a National Health Care System (PUMa - Protection Universelle Maladie included).\n\n    Distinct inclusion criteria for STEP 1 and STEP 2 STEP 1\n11. No prior first-line chemotherapy (5-FU or gemcitabine based, or FOLFIRINOX) for metastatic disease; if treatment with any investigational medicinal product (IMP) the delay before the last dose and inclusion more than or equal to 28 days, Note: relapse after FOLFIRINOX adjuvant chemotherapy in case of resectable disease is NOT allowed,\n12. No dihydropyrimidine dehydrogenase (DPD) deficiency (Uracilemia dosage \\>16 ng\u002Fml), Uracilemia dosing results must be available before inclusion).\n\nSTEP 2 11. Metastatic disease, 12. L2 therapy after progression under 5-FU-based chemotherapy for localized\u002Flocally advanced or metastatic stage, Note: relapse \\\u003C4 months after the end of adjuvant chemotherapy in case of resectable disease is allowed.\n\nExclusion Criteria:\n\nOverlapping exclusion criteria for STEP 1 AND STEP 2\n\n1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study,\n2. History of allogenic organ transplantation or active autoimmune, connective tissue disorder, or inflammatory disease requiring systemic treatment,\n3. Diagnosis of any second malignancy that required any treatment within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,\n4. History of idiopathic pulmonary fibrosis, interstitial lung disease (ILD), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening (TAP-CT-scan),\n5. Current systemic steroid therapy (\\>10 mg daily dose of prednisone or equivalent; minimal wash-out of 1 week \\[7 days\\]) or immunosuppressive therapy,\n6. Prior radiotherapy treatment to more than 30% of the bone marrow or a wide field of radiation within 4 weeks (30 days) prior to the first dose of study drug,\n7. Major surgical procedure (as defined by the Investigator) within 4 weeks (30 days) prior to the first dose of trial treatment (Step 1 and Step 2), Note: Local surgery of isolated lesions for palliative intent is acceptable,\n8. Uncontrolled central nervous system metastases and\u002For carcinomatous meningitis,\n9. Uncontrolled massive pleural effusion or massive ascites,\n10. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions (e.g. bleeding, inflammation, occlusion, malabsorption syndrome, ulcerative colitis, gastrointestinal ulceration, infection or sepsis, inflammatory bowel disease or partial bowel obstruction) associated with diarrhea, or geographical\u002Fsocial\u002F psychiatric illness situations that would limit compliance with study requirement and study follow-up, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent,\n11. History or current evidence of any condition, therapy, laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant in the opinion of the treating investigator,\n12. QT\u002FQTc interval \\>470 ms (for women) and \\> 450 ms (for men), previous ventricular arrhythmia, known or suspected long-QT syndrome, Note: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: \u002F\u002Fwww.crediblemeds.org.\")\n13. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients,\n14. Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (HBV, known positive HBV surface antigen \\[HbsAg\\] result), hepatitis C (HBC, with positive RNA), or human immunodeficiency virus (HIV positive 1\u002F2 antibodies), Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HbsAg test and a positive hepatitis B core antigen \\[HBc\\] antibody test) are eligible; patients with previously treated and cured HCV infection (negative RNA) are also eligible,\n15. Live vaccine administration within 4 weeks (30 days) prior to the first dose of study treatment,\n16. Pregnancy\u002Fbreast-feeding\u002Flactation,\n17. Under a legal protection measure (guardianship, curatorship, or judicial safeguard), administrative decision, and\u002For incapable of giving his\u002Fher consent.\n\nDistinct exclusion criteria for STEP 1 and STEP 2 STEP1 18. Any unresolved NCI CTCAE toxicity of grade ≥ 2 from previous anticancer therapy (including peripheral neuropathy of grade ≥ 1) except for alopecia or vitiligo, 19. Any previous chemotherapy for advanced disease, 20. Uncontrolled central nervous system metastases and\u002For carcinomatous meningitis, 21. Peripheral neuropathy with functional discomfort \\> grade 2, 22. Clinically significant active heart disease or myocardial infarction within 6 months given the cardiotoxicity of 5-FU, 23. Abnormal values of potassium, magnesium, and calcium levels at inclusion, 24. Patients with known homozygous UGT1A1\\*28 (Gilbert's disease), 25. Any use of strong CYP3A4 inducers\u002Finhibitors and\u002For strong UGT1A1 inhibitors (patients are ineligible if unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving first dose of NAL-IRI injection), or presence of any other contraindications for irinotecan), 26. Brivudine-based treatment within 4 weeks preceding treatment initiation. STEP 2 18. Antibiotics use in the month before the day of treatment initiation or for \\> 5 days within 3 months before the day of treatment initiation, 19. Previous gemcitabine-based chemotherapy, 20. Known previous colonization or infection with K. pneumoniae resistant to quinolones, 21. Prophylactic phenytoin within 1 week (7 days) prior to the first dose of study treatment, 22. Any contra-indication to ciprofloxacin: history of fluoroquinolone-related severe side effects (muscle, tendons, joint…), severe aortic disease (aneurysm, dissection), myasthenia, epilepsy, 23. Inability to take oral treatment, 24. Concomitant medication with CYP1A2 substrates (e.g., theophylline, clozapine, duloxetine, tizanidine, olanzapine, propranolol, amitryptilin, and methotrexate, 25. Known glucose-6-phosphate dehydrogenase deficiency.",{"count":731,"type":22},206,[426],"The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.",[31],"2025-06-26",{"date":737,"type":48},"2025-07-01",{"date":739,"type":22},"2025-07",{"date":741,"type":22},"2030-12",{"name":743,"class":167},"GERCOR - Multidisciplinary Oncology Cooperative Group"]