Not Yet RecruitingPhase 1/2

Phase Ib/II 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

48 participantsStarted 2026-01-01

Plain-language summary

This study is an Ib/II 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. Approximately 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed written informed consent form (ICF) * Age 18-75 years * Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer. * Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel). * ECOG Performance Status(PS) score of 0-1. * At least one measurable lesion according to RECIST v1.1 criteria. * Adequate organ and bone marrow function Exclusion Criteria: * Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc. * Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies. * 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). * History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases. * Clinically significant cardiovascular/cerebrovascular diseases * Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components

What they're measuring

Adverse events (AEs)

Timeframe: Up to approximately 36 months

Progression-Free Survival(PFS)

Timeframe: Up to approximately 6 months

Trial details

NCT IDNCT07342725

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31