[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-and-metastatic-pancreatic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-and-metastatic-pancreatic-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100639866","phase-1-nalirifoxadebrelimabpulsar-for-advanced-pancreatic-cancer-100639866",false,"NCT07595172","NALIRIFOX+Adebrelimab+PULSAR for Advanced Pancreatic Cancer","A Phase I\u002FII Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Age: 18-75 years, regardless of gender.\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Previously untreated, locally advanced unresectable or metastatic PDAC, with at least one measurable lesion (RECIST v1.1) not previously irradiated.\n* ECOG Performance Status (PS): 0-1.\n* Expected survival ≥ 3 months.\n* Willing and able to comply with study procedures, treatment, and follow-up.\n* No contraindications to radiotherapy.\n* Adequate organ function: WBC ≥ 2.5×10⁹\u002FL, ANC ≥ 1.5×10⁹\u002FL; Platelets ≥ 75×10⁹\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL (no transfusion or EPO dependence within 7 days); Total bilirubin (Tbil) ≤ 1.5×ULN; ALT\u002FAST ≤ 5×ULN;Albumin ≥ 30 g\u002FL; INR ≤ 1.5×ULN; Serum creatinine (Cr) ≤ 1.5×ULN Urine protein ≤ 1+\n* HBsAg-positive patients must have HBV-DNA ≤ 1×10³ IU\u002FmL (copies\u002FmL). If HBV-DNA ≥ 1×10³ IU\u002FmL, patients may still be eligible if chronic HBV is stable and not expected to increase risk, per investigator assessment.\n* Voluntary participation with signed informed consent form.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity to chimeric, human(ized) antibodies, or fusion proteins.\n* Pregnant or breastfeeding women, or men\u002Fwomen of childbearing potential unwilling\u002Funable to use effective contraception during the study.\n* Other malignancies within 5 years, except: Malignancies treated with curative intent and no known active disease for ≥5 years with low recurrence risk; Adequately treated non-melanoma skin cancer or lentigo maligna without disease evidence; Adequately treated carcinoma in situ (e.g., cervical, breast) with no current disease.\n* Symptomatic moderate\u002Fsevere pleural effusion or ascites.\n* Active bleeding or coagulopathy (PT \\>16s, APTT \\>43s, INR \\>1.5×ULN), bleeding tendency, or current use of thrombolytics\u002Fanticoagulants\u002Fantiplatelets.\n* GI bleeding within 6 months or high bleeding risk (e.g., active ulcer with occult blood++). If occult blood+ persists, endoscopy required.\n* High-risk esophageal\u002Fgastric varices needing intervention.\n* History of drug abuse, psychiatric disorder, or inability to abstain.\n* Solid organ\u002Fbone marrow transplant, or active autoimmune disease requiring systemic treatment within 2 years.\n* Immunodeficiency or HIV infection.\n* Objective evidence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation-\u002Fdrug-induced pneumonitis, or severely impaired pulmonary function.\n* Major surgery within 4 weeks or minor surgery within 1 week (e.g., tooth extraction).\n* Vaccination within 30 days before the first dose.\n* Abdominal fistula, GI perforation, or abscess within 4 weeks.\n* Any clinically significant abnormality affecting safety per investigator, including: Active infection requiring systemic therapy; Uncontrolled diabetes\u002Fhypertension (BP \\>140\u002F90 mmHg despite ≤2 antihypertensives); Myocardial infarction within 6 months; Thyroid dysfunction (\\>NCI CTCAE v4.0 Grade 1).\n* Other conditions deemed ineligible by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to evaluate the safety and preliminary efficacy of NALIRIFOX combined with adebrelimab and PULSAR as first-line treatment for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Additionally, it will explore potential predictive and efficacy-related biomarkers.",[28,29],"Pancreatic Ductal Adenocarcinoma (PDAC)","Locally Advanced and Metastatic Pancreatic Cancer",[31,32,33,34],"chemotherapy","immunotherapy","radiotherapy","PDAC","RECRUITING","2026-05-16",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":21},"2026-04",{"date":43,"type":21},"2029-03",{"name":45,"class":46},"West China Hospital","OTHER"]