[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619292":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":24,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":29,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":11,"studyType":39,"phases":40,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL",null,[13],"Drug: IBI363 + chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","IBI363 + chemotherapy","IBI363+chemotherapy",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","BAIYONG SHEN","professor",[25],{"name":26,"class":6},"Innovent Biologics, Inc.","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",false,"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","ALL","18 Years","75 Years",{"count":37,"type":38},48,"ESTIMATED","INTERVENTIONAL",[41,42],"PHASE1","PHASE2","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.",[45],"Pancreatic Cancer Metastatic","NOT_YET_RECRUITING","2026-01-14",{"date":49,"type":50},"2026-01-15","ACTUAL",{"date":52,"type":38},"2026-01-01",{"date":54,"type":38},"2028-12-31",{"name":5,"class":6}]