[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-cancer-metastatic":363},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,60,86,111,140,168,196,218,248,275,307,330,350,382,428,453,482,502,522,542,568,588,606,629,653],{"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":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100636166","phase-3-atebimetinib--gnp-as-a-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100636166",false,"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","ALL","18 Years",{"count":21,"type":22},510,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.",[28,29,30,31,32,33,34,35],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Adenocarcinoma Metastatic","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma",[37,38,39,40,41,42,43,44,45,46],"mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","KRAS","pan-RAS","RECRUITING","2026-08-20",{"date":50,"type":51},"2026-08-21","ACTUAL",{"date":53,"type":51},"2026-06-05",{"date":55,"type":22},"2029-02",{"name":57,"class":58},"Immuneering Corporation","INDUSTRY",38,{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"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":69,"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.",[28,29,30,31,34,33,35,73],"Pancreatic Adenosquamous Carcinoma",[28,30,32,75,45,76,29,33,73,35],"RAS","RAS Mutation","2026-08-19",{"date":50,"type":51},{"date":80,"type":51},"2026-05-22",{"date":82,"type":22},"2030-04-22",{"name":84,"class":58},"Revolution Medicines, Inc.",6,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":7},"100630728","phase-3-study-of-daraxonrasib-and-daraxonrasib--gnp-as-first-line-treatment-in-patients-with-metastatic-pancreatic-adenocarcinoma-100630728","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.",{"count":95,"type":22},900,[25],"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.",[28,29,30,31,34,33,35,73],[28,30,32,75,45,100,101,102,76,29,33,73,35],"NRAS","HRAS","RAS Wild-Type","2026-08-14",{"date":105,"type":51},"2026-08-18",{"date":107,"type":51},"2026-03-09",{"date":109,"type":22},"2029-03",{"name":84,"class":58},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":138,"locationsCount":139},"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.",[30,31,121,28,29,33,35,73],"Metastatic Pancreas Adenocarcinoma",[123,124,125,126,127,128,129,130,131,132,75,45,29,33,73,35,133],"Expanded Access Program (EAP)","EAP","Daraxonrasib","RMC-6236","RMC-0706236","Metastatic pancreatic adenocarcinoma","Pancreatic ductal adenocarcinoma (PDAC)","RAS(ON) inhibitor","Unmet medical need","Pancreatic cancer","Compassionate Use","AVAILABLE","2026-08-13",{"date":137,"type":51},"2026-08-17",{"name":84,"class":58},241,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100651818","phase-2-vilastobartretifanlimab-in-brca-or-palb2-deficient-pc-100651818","NCT07765836","Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC","A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)","EKLAVYA-HRD","Inclusion Criteria:\n\n* Participant must have histologically proven metastatic pancreatic cancer. Histologies including acinar cell carcinoma, carcinoma, ductal carcinoma, ductal adenocarcinoma, poorly differentiated or adenosquamous carcinoma are allowed.\n* Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certified assay. Somatic pathogenic alterations detected on circulating tumor DNA need confirmation on tumor tissue NGS. Germline pathogenic alterations in BRCA1, BRCA2 or PALB2 do not require further confirmation on tumor NGS. All genomic reports be verified in writing (via email) by site and\u002For overall PI.\n* Participants must have measurable disease per RECIST version 1.1.\n* Participant must have at least one disease site which is amenable to safe biopsy and must agree to pre- and on-treatment biopsies (core, incisional, or excisional biopsy) of tumor site. In select cases biopsies can be waived after discussion with the Sponsor Investigator.\n* Participant must have had at least one but not more than two lines of cytotoxic chemotherapy for metastatic disease. Receipt of neoadjuvant or adjuvant therapy within the last 12 months may count as one line of therapy in metastatic setting for patients with recurrent disease who are being considered for the study. Receipt of targeted therapy such as KRAS inhibitor, or PARP inhibitor is not counted line of therapy. Recycling of the same agents from prior lines of cytotoxic chemotherapy after disease progression does not count as a new line of therapy.\n* Participant must have had prior platinum containing chemotherapy with at least a best response of stable disease. Participants with primary disease progression on platinum chemotherapy are ineligible.\n* Age ≥18 years\n* ECOG performance status of 0-2.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1,000\u002FmcL\n  * platelets ≥75,000\u002FmcL\n  * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN). For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, total bilirubin ≤ 3 × ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN. For patients with liver metastases, AST and ALT ≤ 5 × ULN\n  * glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m\\^2\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* It is not known what effects study treatment has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal for at least 1 year before the screening visit, or\n* Surgically sterile, or\n* Women of childbearing potential must:\n\n  * agree to practice 1 effective method of contraception from the time of signing of the informed consent form through 5 months after the last dose of study drug.\n  * Agree not to breastfeed from the time of signing of the informed consent form through 5 months after the last dose of study drug\n  * Have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration.\n* Male patients must agree to practice 1 effective method of contraception from the time of signing of the informed consent form through 7 months after the last dose of study drug.\n\nHighly effective methods of contraception include:\n\n* Sexual abstinence (no sexual intercourse)\n* Hormonal birth control\n* Intrauterine device (IUD) or intrauterine system (IUS)\n* Bilateral tubal ligation (both tubes tied)\n* Vasectomy - Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants with neuroendocrine tumors of the pancreas are excluded.\n* Prior anticancer therapy:\n\n  * Received prior treatment with anti-CTLA-4 therapy\n  * Received prior immune-checkpoint anti-PD-1\u002FPD-L1 therapy\n  * Received prior approved systemic anticancer therapy within 2 weeks or within its 5 half-lives prior to study treatment, whichever is shorter. Note: Long-standing hormonal therapy for prostate, breast, uterine, and adrenal cancer may be permitted to continue if it is deemed to be in the best interest of the patient, after discussion with the Sponsor Investigator.\n  * Received prior radiotherapy within 2 weeks prior to study treatment. Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia or stable, Grade ≤ 2 non-autoimmune chemotherapy-induced peripheral neuropathy.\n* Participants with uncontrolled intercurrent illness that would interfere with ability to participate in the opinion of the treating investigator.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has an active infection requiring systemic intravenous or oral therapy within 7 days of cycle 1 day 1.\n* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. COVID-19 vaccination should not be given within 7 days of trial drug initiation.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n  * Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  * Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n  * Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n  * Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n  * Replacement therapy (e.g. thyroxine, insulin) is not considered a form of systemic therapy and is allowed.\n* Has a history of immune-related (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease regardless of etiology.\n* Subjects with any condition requiring systemic treatment with either corticosteroids (\\>10mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications within 14 days of treatment. Premedication for hypersensitivity reactions (e.g. to contrast for CT or gadolinium for MRI) or for prophylaxis of infusion related reactions is allowed.\n\nExceptions: use of inhaled, intranasal, intraocular, topical, and intraarticular joint injections are allowed\n\n* Participants with a known history of Human Immunodeficiency Virus (HIV) infection are excluded unless they meet all of the following criteria:\n\n  * Stable antiretroviral therapy (ART) for at least 12 weeks prior to enrollment\n  * No history of AIDS-defining conditions.\n  * CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 at screening\n  * HIV viral load ≤ 50 copies\u002FmL at screening.\n  * No significant comorbidities associated with HIV infection that could interfere with the safety or efficacy of the investigational treatment.\n  * No concurrent use of prohibited medications that may interfere with the study drug or cancer therapy\n* Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and\u002For any of its excipients (refer to the IBs and\u002For approved product label for a list of excipients)\n* Participants with brain metastases (active brain metastases) or leptomeningeal disease are not eligible. Patients with treated brain metastases who are off systemic steroids \\> 2 weeks and have documented radiographic stability over 4 weeks since initial brain metastasis diagnosis may be considered in discussion with the Sponsor Investigator.\n* Has a history of allogeneic bone marrow\u002Fstem, cell or solid organ transplantation.\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 6 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia).",{"count":149,"type":22},40,[151],"PHASE2","This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).",[29],[155,156],"BRCA1, BRCA2, or PALB2 mutation","metastatic pancreatic cancer","NOT_YET_RECRUITING","2026-08-10",{"date":103,"type":51},{"date":161,"type":22},"2027-01",{"date":163,"type":22},"2030-12-31",{"name":165,"class":166},"Massachusetts General Hospital","OTHER",1,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":167},"100518444","phase-1-phase-2a-pilot-c3-trial-of-recurrentrefractory-metastatic-advanced-pancreatic-cancer-100518444","NCT06030622","Phase 2A Pilot C3 Trial of Recurrent\u002FRefractory Metastatic Advanced Pancreatic Cancer","Phase 2A Pilot Trial of Metformin, Digoxin, Simvastatin (C3) in Combination With Gemcitabine in Subjects With Recurrent \u002F Refractory Metastatic Advanced Pancreatic Cancer","C3","Inclusion Criteria:\n\n1. Subject ≥18 years with histologically confirmed pancreatic cancer.\n2. Refractory, intolerant to, or with disease progression after at least one standard of care regimen.\n3. ECOG performance status (PS) 0-1.\n4. Pretreatment biopsy and\u002For adequate archival tissue available for BIRC5 protein level evaluation.\n5. Adequate organ and marrow function: absolute granulocyte count ≥1,000\u002Fmm3, platelets ≥100,000\u002Fmm3, total bilirubin ≤ institutional upper normal limit, AST\u002FALT ≤2x institutional upper limit of normal, and creatinine \\\u003C1.5 mg\u002FdL or calculated creatinine clearance \\> 60ml \u002F min (Cockcroft-Gault Equation).\n6. Subject has recovered to CTCAE Grade 1 (except for alopecia) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better.\n7. If participant of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry. Serum pregnancy tests will be conducted at the time of screening, when other blood draws are obtained (See Appendix III: Time-Table of Procedures).\n8. Ability to understand and the willingness to sign a written informed protocol specific consent.\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. No known active infections at the time of enrollment as determined by negative procalcitonin level.\n\nExclusion Criteria:\n\n1. Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first investigational product administration.\n2. Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected.\n3. Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.\n4. Known history of rhabdomyolysis.\n5. History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Investigator.\n6. Known chronic Hepatitis B or C infection.\n7. Have current active infection requiring systemic antibiotic treatment.\n8. History of severe allergic, anaphylactic, hypersensitivity reactions or previous intolerance to Metformin, Simvastatin, and\u002For Digoxin.\n9. Patients with significant cardiac disease or condition listed below (unless clearance obtained by cardiology):\n\n   1. Wolff-Parkinson-White Syndrome.\n   2. Previous MI within last 6 months of C1D1.\n   3. Evidence of residual electrographic pattern consistent with heart block., for example atrio-ventricular (AV) heart block (currently ongoing).\n   4. History of ventricular fibrillation.\n   5. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated.\n   6. Heart failure with preserved LVEF, including constructive pericarditis, and amyloid heart disease.\n10. Acute cor pulmonale, restrictive cardiomyopathy, and Amyloid heart muscle disease.\n11. Participants of childbearing potential who are found to be pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) or nursing.\n12. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or trial results.\n13. Cognitively impaired and diminished capacity.",{"count":7,"type":22},[178,151],"PHASE1","The goals of this trial are: 1) To evaluate the safety and tolerability of C3 administration with Gemcitabine; and 2) To assess the disease response following C3 administration with Gemcitabine. The main question it aims to answer are: 1) Is C3 in combination with Gemcitabine safe, tolerable, and effective for reducing improving advanced stage pancreatic cancer? and 2) Can C3 in combination with Gemcitabine prolong the lives of patients with advanced stage pancreatic cancer. Participants will receive a combination of metformin (850 mg twice a day), digoxin (0.25 mg once a day), and simvastatin (20 mg once a day), also known as C3, and Gemcitabine (as per standard of care) for 2 years. If patients decline Gemcitabine, they will be offered the C3 medications only.",[29],[182,183,184,185,186],"C3 trial","metformin","simvastatin","digoxin","pancreatic cancer","2026-07-31",{"date":189,"type":51},"2026-08-03",{"date":191,"type":51},"2024-04-17",{"date":193,"type":22},"2028-12-30",{"name":195,"class":166},"State University of New York - Downstate Medical Center",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100647813","study-on-the-construction-and-application-of-a-large-model-corpus-for-pancreatic-cancer-based-on-real-clinical-cases-100647813","NCT07713823","Study on the Construction and Application of a Large Model Corpus for Pancreatic Cancer Based on Real Clinical Cases","Inclusion Criteria:\n\n1. Real inpatient cases of pancreatic cancer diagnosis and treatment;\n2. Prioritize the inclusion of cases with MDT discussion records, difficult and complex cases, and fatal cases;\n3. Possess complete electronic medical information (including but not limited to: outpatient medical records, inpatient medical records including admission records, progress notes, surgery\u002Fprocedure records, nursing records, examination and test reports, doctor's orders, discharge\u002Fdeath records, etc.); -\n\nExclusion Criteria:\n\n1. Cases that only underwent a brief transition in emergency\u002Foutpatient departments and did not form a closed loop of diagnosis and treatment;\n2. Cases with incomplete diagnosis and treatment information and missing key indicators.",{"count":203,"type":22},3000,"OBSERVATIONAL","Combining retrospective observational research with artificial intelligence data engineering. Collecting historical electronic medical record data, and through data governance and annotation by artificial medical experts, constructing a structured knowledge base.",[28,29,207,208],"Pancreatic Cancer Non-resectable","Pancreatic Cancer Resectable","2026-07-19",{"date":211,"type":51},"2026-07-21",{"date":213,"type":22},"2026-08-01",{"date":215,"type":22},"2028-05-31",{"name":217,"class":166},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":229,"conditions":230,"keywords":236,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":167},"100608410","holistic-acupuncture-for-patients-with-chemotherapy-induced-nausea-100608410","NCT07201194","Holistic Acupuncture for Patients With Chemotherapy Induced Nausea","HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea","Inclusion criteria\n\n* ≥ 18 years of age\n* Undergoing chemotherapy and experiencing nausea despite adherence to the prescribed antiemetic regimen\n* Understands and speaks Danish\n* Written and orally informed consent\n* Planned for treatment every 14 days\n* At least two chemotherapy cycles planned at the time of inclusion\n\nExclusion Criteria:\n\n* Brain metastases\n* Performance status \\>2",{"count":226,"type":22},90,[228],"NA","The study explores whether acupuncture as a supplement to conventional antiemetic medicine is superior in reducing the level of chemotherapy induced nausea compared to conventional anitemetic medicine alone.\n\nA total of 90 patients experiencing chemotherapy induced nausea will be allocated 1:1 to either acupuncture and antiemetic medicine or antiemetic medicine alone.\n\nThe level of nausea and other cancer related symptoms will be assessed at baseline and 8 and 22 days after enrollment",[231,232,233,234,235,29],"Breast Cancer","Prostate Cancer","Lung Cancer","Gynaecologic Cancer","Colorectal Cancer",[237,238],"acupuncture","chemotherapy induced nauseau","2026-05-27",{"date":241,"type":51},"2026-05-28",{"date":243,"type":51},"2025-11-17",{"date":245,"type":22},"2027-12-31",{"name":247,"class":166},"Vejle Hospital",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":167},"100596036","phase-1-a-phase-ibii-clinical-study-of-regorafenib-combined-with-toripalimab-and-albumin-bound-paclitaxel-for-the-third-line-treatment-of-advanced-pancreatic-cancer-100596036","NCT07040228","A Phase Ib\u002FII Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n1. The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);\n2. Age ≥ 18 years old and ≤ 80 years old;\n3. Patients with unresectable\u002Fmetastatic pancreatic cancer confirmed by histopathology;\n4. Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;\n5. According to RECIST 1.1 criteria, patients must have at least one measurable target lesion;\n6. Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;\n7. Expected survival time ≥ 2 months;\n8. Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9\u002FL, platelets ≥ 100 × 10 \\^ 9\u002FL, and hemoglobin ≥ 90 g\u002FL (No blood transfusion or blood products within 14 days prior to laboratory examination.\n\n   Not treated with granulocyte colony-stimulating factor or other hematopoietic stimulating factors);\n9. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver metastases); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver metastasis);\n10. Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative, And willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Have hypersensitivity reactions to any research drug or its components;\n2. Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);\n3. Heart function and disease meet one of the following conditions:\n\n   1. Long QTc syndrome or QTc interval\\>480 ms;\n   2. Complete left bundle branch block, grade II or III atrioventricular block;\n   3. Severe and uncontrolled arrhythmias requiring medication treatment;\n   4. New York College of Cardiology classification ≥ III;\n   5. Heart ejection fraction (LVEF) below 50%;\n   6. History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.\n4. Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies\u002FmL; Hepatitis C virus RNA exceeding 1x103 copies\u002FmL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;\n5. Human immunodeficiency virus (HIV) infection (HIV antibody positive);\n6. Imaging confirms intestinal obstruction;\n7. Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast\u002Fcervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);\n8. Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;\n9. Patients who require treatment for merging with other malignant tumors;\n10. History of pulmonary hemorrhage\u002Fhemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration;\n11. Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding;\n12. Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome;\n13. Have used other clinical trial drugs within one month before the first administration;\n14. The researchers have determined that patients who are not suitable to participate in this study.","80 Years",{"count":256,"type":22},23,[178,151],"The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is:\n\nPhase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and\u002For phase II clinical recommendations Dose (RP2D).\n\nPhase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients.\n\nParticipants will:\n\nPhase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg\u002Fd (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg\u002Fm2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.\n\nPhase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg\u002Fm2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.",[29],[261,262,263,264,265],"Efficacy","Safety","Advanced pancreatic cancer","Regorafenib","Toripalimab","2026-05-15",{"date":268,"type":51},"2026-05-18",{"date":270,"type":51},"2025-05-26",{"date":272,"type":22},"2027-05-30",{"name":274,"class":166},"Junjie Hang",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"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":283,"type":22},183,[178,151],"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.",[30,31,287,76,288,233,29,289],"NSCLC","MTAP Deletion","Thoracic Cancer",[291,292,293,294,126,295,296],"PRMT5 inhibitor","RAS G12D","Multi RAS","RMC-9805","Thoracic","Targeted therapy","2026-05-12",{"date":299,"type":51},"2026-05-14",{"date":301,"type":51},"2025-05-31",{"date":303,"type":22},"2027-12",{"name":305,"class":58},"Tango Therapeutics, Inc.",18,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":167},"100558333","phase-1-mt-601-administered-to-patients-with-locally-advanced-unresectable-or-metastatic-pancreatic-cancer-100558333","NCT06549751","MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer","A Phase 1 Study With Expansion of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (PANACEA)","PANACEA","Inclusion Criteria:\n\n1. Informed Consent\n2. Age ≥ 18 years\n3. ECOG performance status of 0 to 1\n4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included).\n5. Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n6. Prior receipt of at least 4 doses (\\~2 months) of FFX or NLX with plans for completion of 12 doses (\\~6 months)\n7. Absence of progression during treatment with FFX or NLX (eg. CR, PR, or SD at study entry)\n8. Adequate pulmonary function with partial pressure of oxygen (pO2) on room air of at least 90%\n9. Adequate cardiac function with an ejection fraction ≥ 45%\n10. Adequate organ function, as defined below:\n\n    * Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factor support allowed)\n    * Platelets ≥75,000\u002Fmm3 (supportive medications allowed)\n    * Hemoglobin ≥9 gm\u002FdL (transfusion allowed)\n    * Total bilirubin ≤2.0 × ULN unless considered due to Gilbert's syndrome in which case, ≤ 3.0 x ULN\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5 × ULN if known tumor involvement of liver\n    * Serum creatinine ≤2 × ULN OR estimated glomerular filtration rate (using institutional standard) ≥50 mL\u002Fmin\n11. Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of any study drugs\n\nExclusion Criteria:\n\n1. Known CNS metastases or meningeal carcinomatosis unless treated and controlled for ≥ 3 months prior to the first administration of MT-601 without the need for increasing doses of steroids\n2. Other known active cancer likely to require additional treatment in the next 2 years unless approved by Medical Monitor\n3. Active bacterial, viral, or fungal infection requiring systemic therapy. Patients may be re-evaluated for eligibility upon completion of infection treatment.\n4. Significant cardiovascular risk (eg, coronary stenting within 4 weeks, myocardial infarction within 6 months)\n5. Diagnosis of significant immunodeficiency that in the Investigator or Medical Monitor's judgment would preclude participation in the study.\n6. Administration of systemic steroid therapy (\\> 10 mg\u002Fday of prednisone equivalent) ≤ 7 days prior to the first administration of MT-601\n7. Active autoimmune disease that required systemic treatment in the past 2 years (replacement therapies excluded \\[eg, thyroxine, insulin, physiologic corticosteroids\\])\n8. History of solid organ or hematologic transplant\n9. Known HIV\n10. Evidence of active hepatitis B as defined by:\n\n    1. Positive hepatitis B surface antigen (HBsAg), or\n    2. Negative HBsAg but a positive hepatitis B surface antibody (HBsAb) or positive hepatitis B core antibody (HBcAb) with a positive hepatitis B virus (HBV) DNA\n11. Evidence of active hepatitis C as defined by:\n\n    a. Positive anti-hepatitis C virus antibody (HCVAb) with a positive hepatitis C virus (HCV) RNA by PCR\n12. Pregnant or currently breast-feeding\n13. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements",{"count":59,"type":22},[178],"The goal of this clinical trial is to assess safety and tolerability of escalating doses of MT-601 administered during the off week of chemotherapy regimen for patients with pancreatic cancer. The main question\\[s\\] it aims to answer are: safety and efficacy • overall response rate and duration of response. Participants will meet all applicable inclusion criteria prior to chemotherapy and must agree to provide apheresis material.",[319,29,320],"Pancreas Cancer","Pancreatic Cancer (Unresectable)","2026-05-10",{"date":323,"type":51},"2026-05-13",{"date":325,"type":22},"2026-07-16",{"date":327,"type":22},"2028-09-16",{"name":329,"class":58},"Marker Therapeutics, Inc.",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":167},"100635228","phase-1-phibrandomgemcitabinegwor-wout-pitavastatinpmaintx-unresecpancreaticadenocarcinomaupdac-100635228","NCT07549958","PhIbRandomGemcitabine(G)w\u002For w\u002FOut Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)","Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Provision of a signed and dated ICF by the participant\n* Has a diagnosis of histologically or cytologically confirmed metastatic, recurrent, or locally advanced PDAC\n* Receiving a gemcitabine-based treatment regimen for a minimum of 2 and a maximum of 4 cycles without radiographic progression (ie SD or better).\n* Measurable disease per RECIST 1.1\n* Adequate organ (hematologic, hepatic, renal) function defined below:\n* Hemoglobin ≥ 9.0 g\u002FdL (transfusion is allowed)\n* Platelets ≥ 100,000\u002FmcL (transfusion is allowed)\n* ANC ≥ 1500\u002FmcL\n* AST\u002FALT ≤ 3 x ULN (≤ 5 x ULN is allowable in cases of liver metastasis or Gilbert's Syndrome)\n* Serum bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN OR creatinine clearance \\> 60 mL\u002Fmin\n* ECOG PS 0-2\n* 2 lines or less of prior treatment. Prior curative intent treatment (surgery and, if given in the adjuvant setting, systemic therapy and\u002For radiation) is permitted, regardless of time to recurrence, and does not constitute a line of therapy. This includes participants with residual disease after surgery, who received systemic therapy, chemoembolization, or radiotherapy.\n\nExclusion Criteria:\n\n* Uncontrolled significant clinical illness\n* Clinically significant autoimmune disease\n* Major surgery within 4 weeks of the first dose of registration\n* Known prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Concomitant use of statin therapy (to be discontinued 2 weeks prior to the start of C1D1).\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HbsAg) are eligible.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Patients with a known history of HIV.\n* Known active metastases in the central nervous system (unless stable by brain imaging studies for at least 1 month after last treatment)\n* Patients with QT interval corrected by Fridericia's formula (QTcF) \\> 470 msec for both men and women on screening ECG are excluded.\n* A woman of childbearing potential who has a positive pregnancy test prior to initiating study treatment.\n* Breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 5 months after the last dose of study treatment.\n* Medicines known to inhibit or induce either CYP2C8, CYP2C9, or CYP3A4\n* History of prior organ or stem cell transplant.\n* Has an active infection requiring systemic therapy. Systemic treatment used prophylactically is allowable.\n* Patients who are unable to swallow or retain oral medication.",{"count":306,"type":22},[178],"This is a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease.",[28,29],"2026-04-28",{"date":343,"type":51},"2026-05-04",{"date":345,"type":51},"2026-03-24",{"date":347,"type":22},"2028-03-31",{"name":349,"class":166},"University of California, Irvine",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"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":359,"type":22},144,[178,151],"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.",[363,31],"Pancreatic Cancer, Metastatic",[30,365,366,28,367,368,369,370,371],"Molecular Targeted Therapy","Drug Delivery Systems","Epidermal Growth Factor Receptor","Bispecific Antibodies","Antineoplastic Agents","Immunotherapy","Disease Progression","2026-02-26",{"date":374,"type":51},"2026-02-27",{"date":376,"type":51},"2026-01-12",{"date":378,"type":22},"2028-09",{"name":380,"class":58},"Engeneic Pty Limited",4,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":408,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":167},"100624518","phase-1-ebnk-001-allogeneic-nk-cells-with-low-dose-il-15--pembrolizumab-in-advanced-solid-tumors-100624518","NCT07410676","EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors","An Open-Label Phase 1\u002F2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide\u002FFludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors","EBNK-ST-001","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed advanced\u002Fmetastatic solid tumor that is relapsed\u002Frefractory after standard therapy (or no standard therapy available).\n* Measurable disease per RECIST v1.1 (or iRECIST if applicable).\n* ECOG performance status 0-1 (or 0-2 as allowed).\n* Adequate organ function (thresholds modeled on NK protocols):\n* Platelets ≥ 75,000\u002FµL; hemoglobin ≥ 9 g\u002FdL; ANC ≥ 1,000\u002FµL (unsupported by growth factors\u002Ftransfusions as defined).\n* eGFR ≥ 60 mL\u002Fmin\u002F1.73m².\n* AST\u002FALT ≤ 3× ULN.\n* Oxygen saturation ≥ 90% on room air (with PFT requirements if indicated).\n* LVEF ≥ 40% (by ECHO\u002FMUGA\u002FCMR).\n* If brain metastases are present, they must be stable for a defined period (example: ≥3 months) and not requiring escalating steroids.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Any condition requiring systemic immunosuppression (e.g., \\>5 mg prednisone\u002Fday or equivalent) during dosing window (topical\u002Finhaled may be allowed).\n* Active autoimmune disease requiring systemic immunosuppression.\n* Uncontrolled bacterial, fungal, or viral infection.\n* Receipt of investigational agent within 28 days before first study drug.\n* Live vaccine within 6 weeks prior to lymphodepletion.\n* Known HIV positivity or active hepatitis B\u002FC with detectable viral load (protocol may allow chronic asymptomatic hepatitis depending on risk plan).\n* Known allergy to investigational product components (example: albumin\u002Fhuman or DMSO).\n* Any medical\u002Fsocial condition likely to interfere with study compliance or increase risk.",{"count":391,"type":22},83,[178,151],"This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide\u002Ffludarabine (CY\u002FFLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced\u002Fmetastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.",[395,396,397,398,399,235,400,401,402,29,403,404,405,406,407],"Cancer","Sarcoma","Leukaemia","Breast Cancer (Locally Advanced or Metastatic)","Lung Cancer (Diagnosis)","Melanoma (Skin Cancer)","Bladder Cancer","Kidney Cancer","Liver Cancer (Primary and Metastatic)","Ovarian Cancer","Esophageal Cancer","Glioblastoma","Non-Melanoma Skin Cancer",[409,410,411,412,231,413,232,414,415,407,416,401,417,28,418,405],"Natural killer cells","NK cell therapy","Solid tumors","IL-15","Lung and Bronchus Cancer","Colorectal (Colon and Rectal) Cancer","CAR-T","Melanoma","Kidney (Renal Cell and Renal Pelvis) Cancer","Stomach (Gastric) Cancer","2026-02-14",{"date":421,"type":51},"2026-02-18",{"date":423,"type":51},"2026-02-01",{"date":425,"type":22},"2029-12-21",{"name":427,"class":166},"Essen Biotech",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":450,"locationsCount":452},"100573940","phase-3-polymeric-micellar-paclitaxel-for-metastatic-pancreatic-cancer-100573940","NCT06752811","Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer","A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Clinical Trial for Evaluating the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection Plus Gemcitabine and Paclitaxel for Injection (Albumin-bound) Plus Gemcitabine for Injection in the First-line Treatment of Metastatic Pancreatic Cancer","pompom","Inclusion Criteria:\n\n* 1\\) Men or women aged 18 to 75 years old (including the critical value).\n* 2）Metastatic pancreatic cancer confirmed by histology or cytology.\n* 3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.\n* 4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* 5）Survival is expected to be at least 3 months.\n* 6）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that is measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and is amenable to accurate repeated measurement. Suspected metastatic lesions (non-regional lymph nodes) that do not meet the above measurable standards and the primary lesions are measurable, the metastatic lesions are confirmed pathologically, can also be included.\n* 7）The major organs function well: a) white blood cell count ≥ 3.0 × 10\\^9\u002FL. b) Hemoglobin ≥ 90.0 g\u002FL. c) Absolute neutrophil count ≥1.5 × 10\\^9\u002FL. d) Platelet count ≥100 × 10\\^9\u002FL. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases.\n\n  g) Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance estimated by Cockcroft Gault formula ≥50 ml\u002Fmin.\n\n  h) International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n* 8）Women of childbearing age are required to have a negative pregnancy test at the screening period and to use a highly effective contraceptive method for 6 months from the screening period to the last dose. Male participants whose partners are women of childbearing age are required to use a highly effective contraceptive method for 6 months after the first dose of a trial product until the last dose.\n* 9）Patients are able to understand the steps of this trial, are willing to follow the clinical trial protocol to complete the trial, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* 1）Patients who are allergic to the investigational drugs and their analogues, or excipients.\n* 2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.\n* 3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.\n* 4）Patients with tumor liver metastasis exceeding 1\u002F2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA\\>500 IU\u002Fml or research center detection limit \\[only when the research center limit is above 500 IU\u002Fml\\]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA \\> research center detection limit).\n* 5） Human Immunodeficiency Virus test is positive.\n* 6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.\n* 7） Patients who have a history of drug or alcohol abuse prior to screening.\n* 8）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.\n* 9） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and\u002For hematemesis within 3 months, hemoptysis).\n* 10） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. NYHA (New York Heart Association) class III or IV heart disease;\n  2. Uncontrollable hypertension (i.e. systolic blood pressure ≥ 160 mmHg, and\u002For diastolic blood pressure ≥ 100 mmHg)；\n  3. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;\n  4. QT interval prolongation corrected for heart rate (corrected for QTc interval using Fridericia formula, males\\>450ms, females\\>470ms);\n  5. Individuals with significant abnormalities in electrocardiogram with clinical significance;\n  6. Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to the first administration;\n* 11） Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, peritoneal effusion, etc. If there were no clinical symptoms, small amounts of pleural effusion or ascites that did not require clinical intervention could be enrolled only after strict control.\n* 12） serious psychiatric disorders in the past or current.\n* 13）Organ transplant recipients.\n* 14）Use of the prohibited medications specified in the protocol is planned during the screening and treatment periods.\n* 15） Patients with a history of psychotropic drug abuse and unable to quit.\n* 16）Before screening, participants have participated in another clinical trial with an investigational nonbiologic agent (administered within the past 30 days or five half-lives, whichever was longer) or an investigational biologic agent (monoclonal or polyclonal antibody) (within the past 4 months or five half-lives, whichever is longer).\n* 17）Pregnant or lactating female patients.\n* 18）Participants who are judged by the investigator to be unable to follow trial procedures or who are judged by the investigator to be unfit to participate in the trial for other reasons.","75 Years",{"count":438,"type":22},416,[25],"This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.",[29],[443],"paclitaxel polymeric micelles for injection","2026-02-09",{"date":446,"type":51},"2026-02-10",{"date":448,"type":51},"2025-02-05",{"date":245,"type":22},{"name":451,"class":58},"Shanghai Yizhong Pharmaceutical Co., Ltd.",2,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":4},"100563412","predictive-value-of-transcriptome-based-oncotreatoncotarget-and-organoid-testing-in-metastatic-pancreatic-cancer-100563412","NCT06615830","Predictive Value of Transcriptome-based OncoTreat\u002FOncotarget and Organoid Testing in Metastatic Pancreatic Cancer.","HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat\u002FOncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer","Inclusion criteria:\n\n* Informed Consent as documented by signature\n* Patients older than 18 years\n* Patients with metastatic pancreatic ductal adenocarcinoma\n* At least one lesion amenable for surgical excisional biopsy\n* ECOG Performance status 0-2\n* Radiologically measurable disease\n* Life expectancy \\> 3 months\n* Absolute leucocyte count \\>1.5 G\u002Fl, platelets \\>100 G\u002Fl\n* Serum creatinine \\\u003C1.5 times of the upper limit of normal or Clearance \\>50ml\u002Fmin (according to the CKD-EPI formula)\n\nExclusion criteria:\n\n* Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens\n* Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy\n* ECOG PS \\>2\n* Heart failure (NYHA class III-IV)\n* Severe or uncontrolled concurrent illness\n* Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment\n* Myocardial infarction within the previous 6 months\n* Patients who are pregnant or breastfeeding",{"count":461,"type":22},185,"Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy.\n\nOverall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression.\n\nNowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient.\n\nPDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient.\n\nOverall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future.\n\nFor HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.",[464,465,29,33],"Pancreas Neoplasms","Pancreatic Neoplasms",[132,467,128,468,469,470,471,472],"Pancreatic adenocarcinoma","Organoid","Organoid-driven chemotherapy","Darwin Oncotreat","Darwin Oncotarget","Personalized chemotherapy","2026-02-07",{"date":475,"type":51},"2026-02-11",{"date":477,"type":22},"2026-06-01",{"date":479,"type":22},"2031-01",{"name":481,"class":166},"Prof. Dr. med. Dres. h.c. Jan Schmidt, MME",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":4},"100619292","phase-1-phase-ibii-study-to-evaluate-the-safety-and-efficacy-of-ibi363-in-combination-with-chemotherapy-as-second-line-therapy-for-unresectable-locally-advanced-or-metastatic-pancreatic-cancer-100619292","NCT07342725","Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Signed written informed consent form (ICF)\n* Age 18-75 years\n* Histologically\u002Fcytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer.\n* Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel).\n* ECOG Performance Status(PS) score of 0-1.\n* At least one measurable lesion according to RECIST v1.1 criteria.\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Previous histologically\u002Fcytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc.\n* Prior treatment with PD-1\u002FPD-L1 inhibitors or other immunotherapies.\n* Unresolved \\> Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy).\n* History of hepatic encephalopathy, seizures, active\u002Fnew\u002Funtreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases.\n* Clinically significant cardiovascular\u002Fcerebrovascular diseases\n* Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components",{"count":489,"type":22},48,[178,151],"This study is an Ib\u002FII phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer.\n\nApproximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.",[29],"2026-01-14",{"date":495,"type":51},"2026-01-15",{"date":497,"type":22},"2026-01-01",{"date":499,"type":22},"2028-12-31",{"name":501,"class":166},"Ruijin Hospital",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":4},"100610647","phase-2-adebrelimab-infusion-plus-standard-care-for-pancreatic-cancer-with-pleural-or-peritoneal-effusions-100610647","NCT07230301","Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions","Intracavitary Infusion of Adebrelimab Combined With the Best Standard Treatment for the Treatment of Pancreatic Cancer With Pleural and Peritoneal Effusions: A Single-Center, Prospective, Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n\nHistologically or cytologically confirmed pancreatic cancer.\n\nPresence of malignant pleural or peritoneal effusion (≥4 cm) confirmed by pathology or cytology, requiring clinical intervention.\n\nAt least one measurable lesion according to RECIST v1.1.\n\nECOG performance status 0-3.\n\nEstimated life expectancy ≥ 2 months.\n\nAdequate organ function:\n\nHemoglobin ≥ 80 g\u002FL\n\nANC ≥ 1.0 × 10⁹\u002FL\n\nPlatelets ≥ 50 × 10⁹\u002FL\n\nTBIL \\\u003C 3 × ULN\n\nALT\u002FAST \\\u003C 5 × ULN\n\nSerum creatinine ≤ 1.25 × ULN or creatinine clearance \\> 45 mL\u002Fmin\n\nChronic HBV infection must be controlled with antiviral therapy and HBV DNA \\\u003C 10,000 IU\u002FmL.\n\nWomen of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for at least 8 weeks after the last dose; men must agree to contraception or have undergone sterilization.\n\nVoluntarily signed informed consent with good compliance for follow-up.\n\nExclusion Criteria:\n\n* Asymptomatic effusion not requiring intervention.\n\nContraindication to paracentesis or drainage.\n\nContraindications to immunotherapy (e.g., chronic steroid use, prior immune-related pneumonitis, hepatitis, or colitis).\n\nActive autoimmune disease requiring systemic therapy.\n\nActive HCV, HIV, syphilis, or tuberculosis infection; uncontrolled severe infection within 4 weeks prior to first dose.\n\nHistory of allogeneic organ transplantation or autologous stem cell transplantation.\n\nSevere pulmonary disease (e.g., pulmonary fibrosis, interstitial lung disease, pneumoconiosis).\n\nHistory of psychiatric illness or substance abuse affecting compliance.\n\nParticipation in another interventional clinical trial within 4 weeks.\n\nPrior treatment with PD-1\u002FPD-L1 antibodies via intrapleural or intraperitoneal route.\n\nUncontrolled CNS metastases or intracranial hypertension.\n\nActive bleeding tendency, GI bleeding within 4 weeks, or ongoing anticoagulation\u002Fthrombolysis therapy.\n\nOther active malignancies (except cured basal cell carcinoma, cervical carcinoma in situ, or superficial bladder cancer).\n\nPregnant or breastfeeding women.\n\nAny other condition judged by the investigator to affect participation or evaluation of the trial.",{"count":510,"type":22},20,[151],"1. Study:\n\n   A Clinical Study of Intra-cavity Adebrelimab Combined with Best Supportive Care for Pancreatic Cancer Patients with Pleural or Peritoneal Effusion (Malignant Ascites)\n2. Why is this study being done? This study is being done to find out if a new approach to treatment is safe and effective for controlling malignant fluid buildup (pleural or peritoneal effusion) in the abdomen or chest in patients with pancreatic cancer. The approach involves putting a drug called Adebrelimab directly into the fluid cavity, in combination with the best available supportive care chosen by your doctor.\n3. What is Adebrelimab? Adebrelimab is a type of immunotherapy drug (a PD-L1 inhibitor) that helps the body's immune system fight cancer cells. It is already approved in China for treating some lung cancers. In this study, it is being given directly into the fluid buildup (intra-cavity) to see if it can work better there.\n4. What will happen if I join the study?\n\n   Screening: First, you will go through tests to see if you are eligible.\n\n   Treatment: If eligible, the fluid will be drained. Then, Adebrelimab will be infused into the cavity on Day 1 and Day 8 of each 3-week cycle. You will also receive the best supportive care for your cancer.\n\n   Monitoring: You will have regular clinic visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.\n5. How long will I be in the study? Treatment will continue as long as it is controlling the disease, you are not experiencing unacceptable side effects, and you choose to remain in the study.\n6. What are the potential benefits? You may experience a reduction in the cancer-related fluid buildup and better control of your cancer. However, benefit cannot be guaranteed. The information from this study may also help other patients in the future.\n7. What are the potential risks and side effects? Possible side effects of Adebrelimab include nausea, fatigue, decreased appetite, vomiting, diarrhea, low blood cell counts, and abnormal liver tests. There may also be unknown risks. The best supportive care has its own risks, which your doctor will explain. You will be monitored closely for safety.\n8. What are my other choices? You can choose not to participate. This will not affect your standard medical care. Your other options may include drainage of the fluid and other standard treatments aimed at managing your symptoms and cancer.\n9. Is participation voluntary? Yes. Your participation is completely voluntary. You can decide to leave the study at any time, for any reason, without any penalty or loss of benefits to which you are entitled.",[29],"2025-11-14",{"date":243,"type":51},{"date":517,"type":22},"2025-11-30",{"date":519,"type":22},"2028-06-30",{"name":521,"class":166},"Sizhen Wang",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":167},"100610708","early-phase-1-a-clinical-study-evaluating-the-safety-tolerability-preliminary-efficacy-and-immunogenicity-of-a-tumor-vaccine-injection-targeting-stressinducible-proteins-micab-in-combination-with-the-ag-regimen-in-patients-with-metastatic-pancreatic-cancer-100610708","NCT07231094","A Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy and Immunogenicity of a Tumor Vaccine Injection Targeting Stressinducible Proteins MICA\u002FB in Combination With the AG Regimen in Patients With Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed unresectable metastatic pancreatic cancer;\n3. No prior systemic anti-tumor therapy for metastatic pancreatic cancer. Neoadjuvant or adjuvant therapy is permitted, provided no disease progression occurred within 6 months after the last administration;\n4. At least one measurable lesion according to RECIST v1.1 criteria;\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1;\n6. Expected survival ≥6 months and ability to receive tumor vaccine and AG regimen treatment;\n7. Adequate organ and bone marrow function at screening, defined as follows:\n\n   Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL without granulocyte colony-stimulating factor support; Platelet count (PLT) ≥100 × 10⁹\u002FL without transfusion; Hemoglobin ≥90 g\u002FL; Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault equation); Total bilirubin (BIL) ≤1.5 × ULN; Aspartate aminotransferase (AST\u002FSGOT) or alanine aminotransferase (ALT\u002FSGPT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); Coagulation parameters: prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN; international normalized ratio (INR) ≤1.5 × ULN.\n8. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan;\n9. Willingness and ability to provide written informed consent and comply with protocol-specified visits and procedures;\n10. Fertile patients (male and female) must agree to use reliable contraception (hormonal, barrier methods, or abstinence) during the study.\n\nExclusion Criteria:\n\n1. Active or prior autoimmune disease, immunodeficiency, or primary immunodeficiency (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis). Exceptions include:\n\n   Autoimmune hypothyroidism controlled with thyroid hormone replacement therapy; Well-controlled type 1 diabetes managed with insulin; Eczema, psoriasis, neurodermatitis, or vitiligo limited to skin involvement, with rash \\\u003C10% of body surface area, stable at baseline, requiring only low-potency topical corticosteroids, and no acute exacerbations within the past 12 months.\n2. Receipt of systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF agents, etc.) within 2 weeks before initiation of study treatment, or anticipated need during the study, except in the following cases:\n\n   Short-term, low-dose systemic immunosuppression or a single pulse dose (e.g., glucocorticoids for 48 hours due to contrast allergy); Use of mineralocorticoids (e.g., fludrocortisone), inhaled corticosteroids, or low-dose corticosteroids (≤10 mg\u002Fday prednisone or equivalent) for chronic obstructive pulmonary disease\u002Fasthma, or low-dose corticosteroids for orthostatic hypotension\u002Fadrenal insufficiency.\n3. History of other malignancies within 5 years prior to screening, except for cancers with negligible risk of metastasis or death (5-year recurrence-free survival \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I endometrial cancer.\n4. Severe cardiovascular, cerebrovascular, gastrointestinal, or hepatic disease, including:\n\n   Significant cardiovascular disease within 3 months prior to treatment (e.g., New York Heart Association \\[NYHA\\] Class III or IV heart failure, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina; Severe colon or rectal disease, or postoperative complications resulting in grade ≥2 diarrhea, intestinal obstruction, or incomplete obstruction; Clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, hereditary liver disease, or investigator-assessed current alcohol abuse.\n5. Active infections requiring treatment, including active HBV or HCV infection; known HIV infection or history of AIDS; active tuberculosis.\n6. Toxicities from prior anti-tumor therapies not resolved to grade ≤2 per NCI-CTCAE v5.0 (or higher version) or baseline, except for alopecia and skin hyperpigmentation (any grade allowed).\n7. Receipt of a live vaccine within 28 days prior to the first study treatment or planned receipt of a live vaccine during the study.\n8. Positive serum pregnancy test or lactating women.\n9. History of severe hypersensitivity to biologic products.\n10. Any other condition that, in the opinion of the investigator, renders the subject unsuitable for study participation.",{"count":529,"type":22},13,[531],"EARLY_PHASE1","Study design:\n\nThis is a single-arm, open-label, dose-escalation and dose-expansion clinical study to evaluate the safety and efficacy of multiple doses of SapDM275 tumor vaccine injection in combination with the AG regimen for the treatment of patients with metastatic pancreatic cancer who have not received prior systemic anti-cancer therapy and are planned to receive AG as first-line treatment.\n\nTreatment must be initiated within 7 days after enrollment. Patients will receive intramuscular injections of SapDM275 tumor vaccine combined with AG regimen until the occurrence of any of the following: disease progression, intolerable toxicity, death (whichever occurs first), the investigator's assessment that the subject is no longer suitable for further treatment, or withdrawal of consent by the subject.",[29],"2025-11-13",{"date":243,"type":51},{"date":537,"type":22},"2025-11",{"date":539,"type":22},"2028-12",{"name":541,"class":166},"The Third Xiangya Hospital of Central South University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":167},"100562612","phase-2-medical-cannabis-in-patients-with-advanced-pancreatic-and-colorectal-cancer-100562612","NCT06605430","Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer","A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic and Colorectal Cancer (CanPan-C)","CanPan-C","Inclusion Criteria\n\n1. Adults (aged 18 or more at enrollment)\n2. Histologically or cytologically proven pancreatic or colorectal cancer. Histologies may include listing of adenocarcinoma, poorly differentiated carcinoma, or other pathology terms that treating oncologist would consider managing per usual standard of care of pancreas and colorectal adenocarcinoma. Neuroendocrine tumors are excluded in both cancer types.\n3. Advanced stage (locally advanced or metastatic) pancreatic or colorectal cancer with no definitive plans for curative surgery in the next 3 months\n4. Self-report of experiencing nausea, vomiting, anorexia, cachexia (wasting), or pain at least once in the 14 days prior to randomization\n5. Plan to initiate or initiated within the past 2 weeks standard-of-care systemic chemotherapy (any regimen that does not include immunotherapy) at a participating institution with no prior systemic therapy in the prior 3 months (prior adjuvant or neoadjuvant chemotherapy is allowed as long as it was \\>3 months prior to randomization)\n6. Must be a resident of Minnesota\n7. Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program\n8. Must be willing to report baseline and required patient-reported outcomes\n\nExclusion Criteria\n\n1. Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product\n2. Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)\n3. Patients with Alzheimer's dementia, active epilepsy, or history of traumatic brain injury\n4. Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period.\n5. Patients initiating or receiving immunotherapy, a chemotherapy-immunotherapy combination, or non-standard cytotoxic chemotherapy (including patients enrolled\u002F enrolling in trials of investigational cancer-directed treatments)\n6. Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control\n7. Uncontrolled acute or chronic medical conditions, psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study\n8. Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance",{"count":551,"type":22},64,[151],"Many patients with advanced pancreatic cancer and colorectal cancer experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called \"symptom burden\") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. Current approaches to manage these cancer-associated symptoms often work poorly, with most patients reporting a moderate to severe symptom burden. Therefore, there is an urgent need for treatments that improve these symptoms in patients with advanced pancreatic and colorectal cancer, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with advanced pancreatic cancer and colorectal cancer to further study how cannabis can impact their symptom burden.",[207,29,555],"Colorectal Cancer Metastatic",[557,558],"medical cannabis","patient-reported outcomes","2025-07-25",{"date":561,"type":51},"2025-07-29",{"date":563,"type":51},"2024-09-16",{"date":565,"type":22},"2026-12",{"name":567,"class":166},"HealthPartners Institute",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":167},"100513722","phase-2-a-single-center-prospective-two-cohort-study-of-surufatinib-combined-with-ag-or-ag-in-the-first-line-treatment-of-locally-advanced-or-metastatic-pancreatic-cancer-100513722","NCT05969171","A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer","A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer","Inclusion Criteria:\n\nSubjects must meet all of the following criteria for enrollment:\n\n1. The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up;\n2. Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;\n3. Aged between 18 and 75 (including 18 and 75), male or female;\n4. ECOG score: 0-1; Expected survival ≥12 weeks;\n5. Patients who had previously received 2 cycles of AG regimen first-line systemic therapy for locally advanced or metastatic pancreatic cancer and whose efficacy was evaluated as CR, PR, SD (excluding SD patients whose efficacy was evaluated as increased after 2 cycles of therapy);\n6. Patients with postoperative distant metastasis had received adjuvant chemotherapy of one type and the distance from adjuvant therapy time \\&gt; Patients with recurrence at 6 months could be included in the group;\n7. At least one measurable lesion (according to RECIST 1.1 criteria); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement accurately measured the diameter of ≥10mm, conventional CT scan to determine the diameter of at least 20mm.\n8. No serious organic diseases of heart, lung, brain and other organs;\n9. The functions of major organs and bone marrow are basically normal:\n\n   1. Blood routine: white blood cells ≥ 4.0 x 109\u002FL, neutrophils ≥ 1.5 x 109\u002FL, platelets ≥ 80 x 109\u002FL, hemoglobin ≥ 90g\u002FL;\n   2. International Standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5× upper limit of normal value (ULN);\n   3. Liver function: serum total bilirubin ≤ 1.5 x ULN, ALT\u002FAST ≤ 3 x ULN, serum total biliary red ≤ 1.5 x ULN after internal\u002Fexternal drainage for obstructive jaundice;\n   4. Renal function: serum creatinine ≤ 1.5 x ULN, creatinine clearance (CCr) ≥ 50mL\u002Fmin;\n   5. Normal cardiac function, left ventricular ejection fraction (LVEF)≥50% by two-dimensional echocardiography;\n10. Fertile male or female patients volunteered to use effective contraceptive methods, such as double screen contraceptives, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization.\n\nThose who met each of the above criteria were included in the study.\n\nExclusion Criteria:\n\nThe study proposal shall be excluded if any of the following criteria are met:\n\n1. Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;\n2. Prior treatment with VEGFR inhibitors or prior treatment with immune checkpoint inhibitors;\n3. Patients with BRCA1\u002F2 germ line mutation;\n4. Patients with obstructive jaundice but failing to reach the expected yellow reduction;\n5. Have had other malignancies within the past 5 years, other than basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n6. Patients who have had or currently have any brain metastases;\n7. The investigators determined that liver metastases accounted for 70% or more of the total liver volume;\n8. Had received any surgery (except biopsy) or invasive treatment or operation within 4 weeks prior to inclusion, and the surgical incision was not completely healed (except intravenous catheterization, puncture drainage, internal\u002Fexternal drainage for obstructive jaundice, etc.);\n9. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage;\n10. Local antitumor therapy, such as hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation, was received within 4 weeks before enrollment;\n11. Electrolyte abnormalities identified by the investigator as clinically significant;\n12. The patient has medically uncontrolled hypertension, as follows: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n13. Urine routine indicated urinary protein ≥2+ and 24-hour urinary protein volume \\&gt; 1.0g;\n14. Patients whose tumors are judged to be at high risk of invading vital blood vessels and causing fatal haemorrhage during the follow-up study;\n15. Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \\&gt; 30 mL, hematemesis, black feces, blood in stool), hemoptysis (within 4 weeks \\&gt; 5 mL fresh blood); A history of hereditary or acquired bleeding or a coagulation disorder. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.;\n16. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\&gt; Level 2; Ventricular arrhythmias requiring medical treatment; Electrocardiogram (ECG) showed a QT c interval ≥480 ms;\n17. Active or uncontrolled severe infection (≥CTCAE grade 2 infection);\n18. Unmitigated toxic reactions higher than CTCAE grade 2 or above due to any previous anticancer therapy, excluding grade 2 or less neurotoxicity due to alopecia, lymphocytopenia, and oxaliplatin;\n19. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n20. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, the patient has a medical condition or condition that is reasonably suspected to be unsuitable for the use of the study drug (such as the presence of epileptic seizures requiring treatment), or which would interfere with the interpretation of the study results, or place the patient at high risk;\n21. Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection must be ruled out as a known carrier of hepatitis B virus (HBV), i.e. positive HBV DNA (\\>1×104 copies\u002FmL or \\>2000 IU\u002Fml); known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL), or other hepatitis, cirrhosis;\n22. The presence of any active, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitaritis, hyperthyroidism, etc.);\n23. Allergy or suspected allergy to the study drug or similar drug;\n24. In the investigator's judgment, the patient had other factors that might affect the study results or lead to the termination of the study, such as alcoholism, drug abuse, other serious medical conditions (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, and family or social factors that would affect the patient's safety.",{"count":576,"type":22},65,[151],"This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer.\n\nParticipants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled:\n\nArm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression\u002Fdeath\u002Fwithdrawn; Arm 2: AG chemotherapy (q3w) until disease progression\u002Fdeath\u002Fwithdrawn;\n\nDuring the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.",[29],{"date":581,"type":51},"2025-07-30",{"date":583,"type":51},"2023-12-05",{"date":585,"type":22},"2026-12-31",{"name":587,"class":166},"Fudan University",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":4},"100599581","influence-of-metastatic-sites-on-survival-outcomes-and-predictive-factors-for-extended-survival-in-metastatic-pancreatic-cancer-a-retrospective-study-100599581","NCT07086352","Influence of Metastatic Sites on Survival Outcomes and Predictive Factors for Extended Survival in Metastatic Pancreatic Cancer a Retrospective Study","Inclusion Criteria:\n\n* Patients diagnosed with metastatic pancreatic cancer over a defined period (e.g., between 2019 and 2024).\n* Adult patients (≥18 years) diagnosed with metastatic pancreatic cancer between January 1, 2019, and December 31, 2023.\n\nExclusion Criteria:\n\n* non metastatic patients",{"count":595,"type":22},60,"Pancreatic cancer remains one of the most lethal malignancies worldwide, with a 5-year survival rate of less than 10%. The majority of patients are diagnosed at an advanced stage, and nearly 50% present with distant metastases at the time of diagnosis. Despite advances in chemotherapy, such as FOLFIRINOX and gemcitabine-based regimens, the prognosis of metastatic pancreatic cancer (mPC) remains extremely poor, with median overall survival typically ranging between 6 to 11 months.\n\nThe pattern of metastasis in pancreatic cancer commonly involves the liver, peritoneum, lungs, and distant lymph nodes. Several studies suggest that the site and extent of metastatic disease may influence survival outcomes, although findings remain inconsistent. For example, liver metastases are frequently associated with worse prognosis, whereas isolated lung metastases may indicate a more indolent disease course. Understanding the prognostic significance of different metastatic sites may provide insight into disease biology and help guide clinical decision-making.\n\nIn addition, identifying clinical and pathological factors associated with extended survival could inform treatment stratification, optimize resource allocation, and guide patient counseling. However, limited data exist regarding the predictors of long-term survival in mPC patients, particularly in real-world clinical settings.\n\nTherefore, this retrospective cohort study aims to investigate the influence of metastatic sites on overall survival and to identify potential predictive factors for extended survival among patients with metastatic pancreatic cancer. This information could contribute to more individualized prognostic assessments and potentially support the development of tailored therapeutic strategies.",[29],"2025-07-18",{"date":559,"type":51},{"date":601,"type":22},"2025-09-01",{"date":603,"type":22},"2026-10-01",{"name":605,"class":166},"Assiut University",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":167},"100586561","phase-2-adebrelimab-combined-with-ag-regimen-in-patients-with-unresectable-locally-advanced-or-metastatic-pancreatic-cancer-100586561","NCT06916975","Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer","A Prospective, Single-Arm, Phase II Clinical Trial of Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer","CSPAC-48","Inclusion Criteria:\n\n* Sign informed consent；\n* Aged 18-75 years (inclusive)；\n* Histologically or cytologically confirmed pancreatic cancer；\n* Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator；\n* Disease progression after prior treatment with at least one systemic therapy;\n* No previous immunotherapy;\n* No previous gemcitabine-based chemotherapy;\n* Have at least one measurable lesion (according to RECIST 1.1 criteria);\n* ECOG 0\\~1；\n* The estimated survival time is greater than 3 months;\n* Adequate Organ Function (within 28 days prior to first dose): Hematology: White blood cell count (WBC) ≥3.0×10⁹\u002FL Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelets (PLT) ≥100×10⁹\u002FL Hemoglobin (HGB) ≥90 g\u002FL Liver Function: Aspartate aminotransferase (AST) ≤2.5×ULN Alanine aminotransferase (ALT) ≤2.5×ULN Total bilirubin (TBIL) ≤1.5×ULN Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥60 mL\u002Fmin (calculated via Cockcroft-Gault formula). Coagulation: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Cardiac Function: No clinically significant abnormalities on electrocardiogram (ECG)；\n* Male subjects and females of childbearing potential must agree to use effective contraceptive measures from the first dose until 3 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* The subject has any known active autoimmune disease;\n* Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (\\> 10mg\u002F day) or have used immunosuppressive drugs within 14 days prior to initial administration;\n* Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;\n* Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;\n* Subjects have other malignancies requiring treatment;\n* Clinically significant cardiovascular disorders；\n* Prior allogeneic organ transplantation or hematopoietic stem cell transplantation；\n* Serologically confirmed HIV infection；\n* Active hepatitis B (HBsAg-positive with HBV-DNA ≥10³ copies\u002FmL). Active hepatitis C (HCV antibody-positive with detectable HCV RNA and requiring antiviral therapy)；\n* Known hypersensitivity to monoclonal antibodies or any component of adebrelimab；\n* History of severe allergic reactions to gemcitabine or nab-paclitaxel；\n* Any situation that the investigator believes may compromise the validity of the trial or patient safety.",{"count":615,"type":22},46,[151],"This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.",[207,29],[186],"2025-04-01",{"date":622,"type":51},"2025-04-08",{"date":624,"type":22},"2025-04-15",{"date":626,"type":22},"2028-12-01",{"name":628,"class":166},"Jin Xu",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":254,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":167},"100580651","clinical-study-of-carbon-ion-radiotherapy-for-pancreatic-cancer-100580651","NCT06840067","Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.","Single-arm Clinical Study of Carbon Ion Radiotherapy Combined with Nituzumab and Gemcitabine for Pancreatic Cancer.","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years;\n2. Indications: patients with locally advanced or metastatic pancreatic adenocarcinoma confirmed by histopathology or cytology (stage III - IV).\n3. At least one measurable lesion was present according to RECIST version 1.1 evaluation criteria.\n4. Suitable for one cycle of gemcitabine combined with nituzumab.\n5. No history of other malignant tumors (except cured skin cancer and stage 0 cervical cancer);\n6. Liver function, kidney function and bone marrow function were basically normal (ALT and AST \\\u003C 1.5 times of high normal value (ULN), bilirubin \\\u003C 1.5×ULN; Adult endogenous creatinine clearance rate of 60ml\u002Fmin or serum creatinine SCR≤140μmoI\u002FL, BUN≤6.8mmol\u002FL; Hemoglobin level \\>9 g\u002FdL; White blood cell count ≥3.0\\*109\u002FL; Platelet count ≥100\\*109\u002FL;)\n7. Good physical condition, i.e. ECOG (Eastern United States Oncology Collaboration Group) 0\\~2; There were no complications such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, and severe chronic heart disease that may affect radiotherapy. Cardiac function grade 1. (According to the New York College of Cardiology Cardiac Function Scale (NYHA)\n8. Adequate functions of major organs;\n9. Predicted survival (after treatment) ≥3 months;\n10. Informed consent has been signed by the patient or his legal representative before radiotherapy.\n\nExclusion Criteria:\n\n1. Patients who have received monoclonal antibodies, EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressants within six months.\n2. Patients with uncontrolled, cancerous pleural effusion requiring frequent drainage, pericardial effusion, or ascites (allowing for cytological confirmation of effusion), gastrointestinal bleeding, or those identified by the investigator as having a high blood risk within 14 days prior to admission.\n3. Participated in other interventional clinical trials within 30 days prior to screening.\n4. The dose limit for organs at risk cannot reach the preset safe dose limit.\n5. Being on chronic steroid hormone therapy for more than 6 months (e.g., prednisone dose \\> 10 mg\u002F day or equivalent).\n6. People who are allergic to the drugs or their ingredients used in this program.\n7. Pregnancy (confirmed by serum or urine β-HCG test) or lactation\n8. Persons with AIDS, including those who have received antiretroviral therapy; Active stage of syphilis;\n9. Accompanied by serious comorbiditions, including uncontrolled systemic or co-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver, kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction, and\u002For mental illness that prevent the successful implementation of the trial protocol;\n10. Patients with poor compliance, including those who may not be able to complete the treatment plan or receive prescribed follow-up and examination;\n11. Patients had other malignant neoplasms (except cured skin cancer and stage 0 cervical cancer);\n12. There are contraindications to radiotherapy;\n13. having no or limited capacity for civil conduct;\n14. Any medical history that, in the investigator's judgment, might interfere with the trial results or increase the patient's risk;\n15. Any condition in which the physician considers that participation in the trial is not appropriate, the physician determines that the patient will not benefit from carbon ion radiotherapy, or that there are other co-existing conditions or other factors that may affect carbon ion therapy.\n16. Inability to understand the purpose of treatment or unwillingness\u002Finability to sign treatment consent.",{"count":637,"type":22},62,[228],"The objective is to evaluate the efficacy and safety of carbon ion radiotherapy (CIRT) combined with nituzumab and gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer.",[29,207],[642,186,643,644],"Carbon Ion Radiotheray","Nimotuzumab","Gemcitabine","2025-03-22",{"date":647,"type":51},"2025-03-25",{"date":649,"type":51},"2025-03-01",{"date":499,"type":22},{"name":652,"class":166},"Gansu Wuwei Tumor Hospital",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":436,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":662,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":669,"leadSponsor":671,"locationsCount":167},"100584385","phase-1-personalized-tumor-neoantigen-mrna-therapy-for-advanced-pancreatic-cancer-100584385","NCT06888648","Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.","Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.","Inclusion Criteria:\n\n(1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study:\n\n1. Voluntary signing of the informed consent form;\n2. Age: 18 and 75 years old, male or female;\n3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;\n4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.\n5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;\n6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1);\n7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis;\n8. Main organ function of heart, liver and kidney is normal:\n9. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause;\n10. Ability to follow the study protocol and follow-up procedures.\n\n(2) Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process:\n\n1. Voluntary signing of the informed consent form;\n2. Age: 18 and 75 years old, male or female;\n3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology);\n4. No systemic treatment or gemcitabine-based first-line chemotherapy.\n5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1;\n6. Main organ function of heart, liver and kidney is normal:\n7. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause;\n8. Ability to follow the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\nSubjects will be excluded from this study if they meet any of the following criteria:\n\n1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis;\n2. At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;\n3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;\n4. Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;\n5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis;\n6. Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B;\n7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks);\n8. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator;\n9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness;\n10. Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator.\n11. Women born during pregnancy or lactation;\n12. The investigator is not fit for enrollment or may not complete the trial for other reasons.",{"count":661,"type":22},30,[178,151],"This study is a single-arm phase I\u002FII clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.",[29,207],"2025-03-15",{"date":667,"type":51},"2025-03-21",{"date":620,"type":22},{"date":670,"type":22},"2028-04-01",{"name":672,"class":166},"Zhejiang University"]