[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-pancreatic-ductal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-pancreatic-ductal":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,76,106,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100612879","phase-2-relacorilant-with-nab-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-adenocarcinoma-100612879",false,"NCT07259317","Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)","Inclusion Criteria:\n\n* Signed and dated informed consent form prior to screening procedures\n* Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)\n* Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study\n* Life expectancy of ≥3 months\n* Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to provide informed consent and comply with protocol requirements\n* Able to swallow and retain oral medication and does not have uncontrolled emesis\n* Has adequate gastrointestinal absorption\n* Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.\n* If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred \\>12 months after completing the last dose, and no persistent treatment-related toxicities can be present.\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n* Agree to use protocol defined precautions to avoid pregnancy\n\nExclusion Criteria:\n\n* Any major surgery within 4 weeks prior to enrollment\n* Prior treatment as follows:\n\n  1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease\n  2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug\n* Received gemcitabine or nab-paclitaxel to treat their PDAC\n* Known germline or somatic breast cancer gene (BRCA) mutation\n* Peripheral neuropathy from any cause \\>Grade 1\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* History of severe hypersensitivity or severe reaction to any of study drugs or their excipients\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Active infection with HIV, hepatitis C or hepatitis B virus\n* Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Taking protocol-prohibited medications\n* Concurrent treatment with other investigational treatment studies for cancer\n* Has received a live vaccine within 30 days prior to the study start date","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).",[26,27],"Adenocarcinoma","Carcinoma, Pancreatic Ductal",[29,26,30,31],"Pancreatic","PDAC","Pancreas","RECRUITING","2026-08-14",{"date":35,"type":36},"2026-08-18","ACTUAL",{"date":38,"type":36},"2026-01-27",{"date":40,"type":20},"2027-09",{"name":42,"class":43},"Corcept Therapeutics","INDUSTRY",16,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100475779","personalized-first-line-chemotherapy-choice-in-advanced-pancreatic-adenocarcinoma-using-transcriptomic-signatures-100475779","NCT05475366","Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures","Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign)","PACsign","Inclusion Criteria:\n\n1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n2. 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.\n3. Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC).\n4. Metastatic disease.\n5. Measurable or evaluable lesions according to RECIST v1.1 criteria.\n6. First-line therapy (previous neoadjuvant\u002Fadjuvant chemotherapy not allowed).\n7. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14).\n8. 3\\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n9. Availability of tumor tissue sample from the primary pancreatic tumor or liver metastasis (chemo-naïve) before inclusion in step 1.\n10. Adequate organ function, as defined by the following (blood test ≤ 7 days prior to inclusion):\n\n    1. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases)\n    2. Total serum bilirubin ≤ 1.5 ULN\n    3. Serum albumin ≥ 28 g\u002FL\n    4. Hemoglobin ≥ 9.0 g\u002Fdl\n    5. Absolute neutrophil count (ANC) ≥ 1,500\u002FμL\n    6. Platelets ≥ 100,000\u002FμL\n    7. Creatinine clearance ≥ 50 mL\u002Fmin (MDRD).\n11. No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level).\n12. Life expectancy ≥ 3 months.\n13. a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy test for female pre-menopausal patients.\n14. Registration in a National Health Care System.\n\nExclusion Criteria:\n\n1. Concurrent enrolment in another interventional clinical study.\n2. Previous treatment with chemotherapy for pancreatic cancer.\n3. Uncontrolled massive pleural effusion or massive ascites.\n4. Known deficiency in UGT1A1 (homozygous UGT1A1\\*28 allele).\n5. Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (known positive Hepatitis B Virus surface antigen (HBsAg) result), hepatitis C (with positive RNA), Sars-Cov-2 or human immunodeficiency virus (positive HIV 1\u002F2 antibodies).\n6. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.\n7. Known active central nervous system metastases and\u002For carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline).\n8. 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 associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n9. Live vaccine administration within 30 days prior to the first dose of study treatment.\n10. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n11. History or current evidence of any condition, therapy, or 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. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n13. Major surgical procedure (as defined by the Investigator) within 4 weeks prior to the first dose of trial treatment.\n14. Pregnancy\u002Flactation.\n15. Person under legal protection or tutelage or guardianship.","75 Years",{"count":55,"type":20},85,[57],"NA","The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.",[27,60],"Prognosis",[62,63,64],"Transcriptomic signatures","Personalized first-line chemotherapy","Metastatic PDAC","2026-04-30",{"date":67,"type":36},"2026-05-01",{"date":69,"type":36},"2022-12-12",{"date":71,"type":20},"2028-12-11",{"name":73,"class":74},"Institut Curie","OTHER",7,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100604728","phase-1-cd318-targeted-car-t-cell-therapy-in-patients-with-pancreatic-cancer-rescpa-100604728","NCT07153289","CD318-targeted CAR-T Cell Therapy in Patients With Pancreatic Cancer (ResCPa)","Response Features, Efficacy and Safety of CD318-targeted CAR-T Cell Therapy Against Pancreatic Cancer - ResCPa Study","ResCPa","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* Histologically confirmed PDAC (metastatic or locally advanced, unresectable)\n* Measurable disease according to RECIST v1.1\n* Disease progression during or after at least one prior line of systemic standard therapy for advanced PDAC\n* CD318 expression in tumor tissue confirmed by central immunohistochemistry (IHC)\n* ECOG performance status of 0 or 1\n* Adequate bone marrow, renal, and hepatic function as defined in the protocol\n* Life expectancy of at least 12 weeks\n* Willingness and ability to comply with study procedures and follow-up\n* Written informed consent obtained prior to any study-specific procedures-\n\nExclusion Criteria:\n\n* Prior treatment with CAR T cells or other genetically modified cell therapies\n* Active uncontrolled infection, including active hepatitis B or C infection or HIV infection\n* Known symptomatic or untreated central nervous system (CNS) metastases\n* Clinically significant cardiovascular disease, including recent myocardial infarction (within 6 months), unstable angina, or uncontrolled arrhythmia\n* History of autoimmune disease requiring systemic immunosuppressive therapy\n* Current or recent (within 4 weeks) participation in another interventional clinical trial\n* Pregnant or breastfeeding women\n* Any condition that, in the opinion of the investigator, would interfere with the patients ability to comply with study requirements or would compromise safety",{"count":85,"type":20},38,[87,23],"PHASE1","Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers, with limited therapeutic options and a five-year survival rate below 10 % in advanced stages. Standard treatments, such as multi-agent chemotherapy, provide only marginal survival benefits and are often associated with significant toxicity. Novel approaches are urgently needed.\n\nThe ResCPa study is a first-in-human, multicenter, phase I\u002FIIa investigator-initiated trial evaluating the safety, feasibility, and preliminary efficacy of autologous CD318-targeted chimeric antigen receptor (CAR) T-cell therapy in patients with metastatic or locally advanced PDAC that has progressed after standard-of-care treatment. CD318 (also known as CDCP1) is highly expressed in primary and metastatic PDAC tissue but rarely found in healthy tissues, making it a promising and potentially safe immunotherapy target. Preclinical studies have shown potent anti-tumor activity of CD318-CAR-T cells in vitro and in PDAC mouse models without target-specific toxicity.\n\nEligible patients will undergo tumor tissue screening for CD318 expression. Those meeting the criteria will proceed to leukapheresis for autologous T-cell collection. The CD318-CAR construct, optimized in preclinical work, will be introduced via a GMP-produced lentiviral vector, and CAR-T cells will be expanded using automated manufacturing (CliniMACS Prodigy). Following lymphodepleting chemotherapy, patients will receive CD318-CAR-T cells in a dose-escalation design to determine the recommended phase II dose, with the option of dual dosing.\n\nThe primary objectives are to assess safety, tolerability, and feasibility of manufacturing and delivering CD318-CAR-T cells. Secondary objectives include preliminary anti-tumor activity (objective response rate, progression-free survival, overall survival), CAR-T cell expansion and persistence, and immunological correlates of response or resistance. Patients will be followed for at least 12 months post-infusion, with extended safety follow-up per regulatory requirements.\n\nIn parallel, an extensive translational research program will investigate CAR-T cell phenotypes, tumor microenvironment changes, and mechanisms of treatment resistance using single-cell multi-omics, spatial proteomics and transcriptomics, organoid co-culture models, and microbiome profiling. Insights from these studies aim to guide optimization of next-generation CAR-T therapies for PDAC and other solid tumors.\n\nThis trial is conducted by a German academic-industrial consortium including the University Hospital Tübingen, Miltenyi Biotec, University Hospital Freiburg, Klinikum rechts der Isar (TUM), Berlin Institute of Health (BIH), and other partners. The study is supported by the German Federal Ministry of Education and Research (BMBF) within the \"National Decade Against Cancer\" initiative.",[27,90],"Pancreatic Neoplasms",[30,92,93,94,95],"Metastatic Pancreatic Cancer","Locally Advanced Pancreatic Cancer","CD318 CAR-T","CAR-T cell therapy","NOT_YET_RECRUITING","2025-08-29",{"date":99,"type":36},"2025-09-03",{"date":101,"type":20},"2026-07",{"date":103,"type":20},"2028-12",{"name":105,"class":74},"University Hospital Tuebingen",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100560150","phase-2-radiotherapy-with-sequential-chemotherapy-combined-with-pd-1-inhibitor-and-thymalfasin-for-brpc-100560150","NCT06573398","Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC","Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, with ECOG score of 0 \\~ 1;\n2. Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;\n3. Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);\n4. Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;\n5. Subjects must meet the following criteria for hematology test:\n\n   1. Neutrophil count ≥ 1.5 × 10\\^9\u002FL\n   2. Hemoglobin ≥ 10 g\u002FdL\n   3. Platelet count ≥ 100 × 10\\^9\u002FL\n6. Subjects must meet the following criteria for blood chemistry tests:\n\n   1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   2. AST and ALT \\\u003C 1.5 × ULN\n   3. Creatinine clearance ≥ 60 mL\u002Fmin\n   4. Good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN\n7. Subjects of childbearing potential should take appropriate protective measures (contraceptive methods or other birth control methods) prior to enrollment and throughout the clinical study;\n8. Has signed the informed consent form;\n9. Capable of complying with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n1. Prior systemic anti-tumor therapy;\n2. Prior medical history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or urothelial bladder carcinoma (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);\n3. Prior history of abdominal radiotherapy;\n4. Subjects with active bacterial or fungal infection (≥ Grade 2 as per NCI-CTC, Version 3).\n5. Subjects with HIV, HCV, or HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases judged by the investigator to be ineligible for enrollment;\n6. Subjects with autoimmune diseases or immunodeficiency and requiring treatment with immunosuppressive agents;\n7. Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test results within 7 days prior to enrollment;\n8. Subjects with drug abuse\u002Fclinical\u002Fpsychological\u002Fsocial factors that affect informed consent or study conduct;\n9. Subjects who may be allergic to PD-1 monoclonal antibody immunotherapy drugs;\n10. Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplant;\n11. Patients requiring treatment with systemic corticosteroids (at dose level \\> 10 mg\u002Fday prednisone efficacy) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, enrollment is permitted if: In the absence of active autoimmune disease, patients are permitted to use topical or inhaled steroids, or adrenal hormone replacement therapy at dose level ≤ 10 mg\u002Fday prednisone efficacy;\n12. Treatment with live vaccines within 28 days prior to the first dose; except for inactivated viral vaccines for seasonal influenza;\n13. Active pulmonary tuberculosis;\n14. Treatment with related drugs or medical technology affecting immunity within 6 months prior to the first dose (including but not limited to: thymopentin, thymalfasin, interferon, CAR-T therapy, etc.);\n15. Patients with other conditions unsuitable for this clinical trial judged by the investigator.",{"count":114,"type":20},20,[23],"This is a prospective, single-center, single-arm, phase II clinical study. The primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel + Gemcitabine chemotherapy + anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer, and to explore clinical indicators related to efficacy, further guiding subsequent individualized precise treatment.",[27],[119,120,121,122,123,124],"borderline resectable","thymalfasin","radiotherapy","chemotherapy","PD-1 inhibitor","pancreatic ductal adenocarcinoma","2024-08-26",{"date":127,"type":36},"2024-08-27",{"date":129,"type":20},"2024-09-01",{"date":131,"type":20},"2027-09-01",{"name":133,"class":74},"Ruijin Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":4},"100487034","a-cohort-study-on-screening-and-follow-up-of-high-risk-population-of-pdac-based-on-eus-100487034","NCT05621824","A Cohort Study on Screening and Follow-up of High-risk Population of PDAC Based on EUS","A Cohort Study on Screening and Follow-up of High-risk Population of Pancreatic Cancer Based on Endoscopic Ultrasonography","Inclusion Criteria:\n\n* From the beginning of the study to the end of the study, the 18-80 year old patients who were admitted to Peking Union Medical College Hospital and related research centers and who met the high-risk population of pancreatic cancer understood and were willing to participate in the study and signed the informed consent form.\n* In this study, the high-risk population of pancreatic cancer is defined as patients who meet any of the following conditions:\n* A. Patients with previous history of pancreatitis (acute or chronic).\n* B. Patients with pancreatic cancer related genetic background, including immediate relatives with a family history of pancreatic cancer. Or genetic syndrome related to pancreatic cancer. \\[including hereditary breast cancer ovarian cancer syndrome (HBOCS), carney complex (CNC), familial adenomatous polyps (FAP), hereditary diffuse gastric cancer syndrome (HDGC), juvenile polyposis (JPS), cutaneous malignant melanoma (CMM), hereditary papillary renal cell carcinoma (HPRCC) and Lynch syndrome\\]\n* C. Patients with continuous or progressive increase of CA19-9 and CEA.\n* D. Patients with potential malignant pancreatic tumors, including mucinous cystic tumor (MCN) and intraductal papillary myxoma of the pancreas (IPMN).\n* E. Newly diagnosed patients with diabetes (within 3 years after diagnosis of diabetes).\n* F. Other patients who are considered as having high risk factors for pancreatic cancer.\n\nExclusion Criteria:\n\n* A. Those who are not suitable for endoscopic examination, including but not limited to: poor general condition, serious heart and lung disease, and difficult to tolerate the examination; coagulation disorders; platelets \\\u003C50 × 10\\^9\u002FL；those who are not suitable for endoscopic examination after interview by an endoscopic physician.\n* B. The patient or family member could not understand the conditions and objectives of this study.","80 Years",{"count":143,"type":20},900,"OBSERVATIONAL","Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.\n\nStudy design: This is a real world, multicenter, prospective, observational cohort study.",[27],[148,149,150],"Early Pancreatic Ductal Adenocarcinoma","Endoscopic Ultrasound","HighRisks for Pancreatic Ductal Adenocarcinoma","2024-04-06",{"date":153,"type":36},"2024-04-09",{"date":155,"type":20},"2024-12",{"date":103,"type":20},{"name":158,"class":74},"Peking Union Medical College Hospital"]