[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639866":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NALIRIFOX+Adebrelimab+PULSAR","EXPERIMENTAL",null,[13,14],"Drug: NALIRIFOX+Adebrelimab","Radiation: PULSAR",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","NALIRIFOX+Adebrelimab","NALIRIFOX chemotherapy and Adebrelimab Injection",[9],[22],"chemotherapy and immunotherapy",{"type":24,"name":25,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","PULSAR",[9],[28],"Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy",[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Kexun Zhou, Dr.","CONTACT","+028 85423609","kexunzhou@wchscu.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"West China Hospital, Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":45,"coordinates":46},"Point",[47,48],104.06667,30.66667,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Wang Xin","Professor",[57],{"name":58,"class":59},"Jiangsu Hengrui Pharmaceutical Co., Ltd.","INDUSTRY","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":71,"type":72},55,"ESTIMATED","INTERVENTIONAL",[75,76],"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.",[79,80],"Pancreatic Ductal Adenocarcinoma (PDAC)","Locally Advanced and Metastatic Pancreatic Cancer",[82,83,84,85],"chemotherapy","immunotherapy","radiotherapy","PDAC","2026-05-16",{"date":88,"type":89},"2026-05-19","ACTUAL",{"date":91,"type":72},"2026-04",{"date":93,"type":72},"2029-03",{"name":5,"class":6},1]