Clinical Trial

A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors

Study acronym: CCGLC-018
Not Yet Recruiting Phase 2
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Summary
This is a prospective, open-label, exploratory, phase II basket clinical trial designed to evaluate the efficacy and safety of sintilimab in combination with pyrotinib with or without chemotherapy in patients with advanced HER2-positive digestive system malignancies. Eligible patients include those with locally advanced unresectable or metastatic gastric, colorectal, hepatocellular, biliary tract, or pancreatic cancers. Patients will receive sintilimab and pyrotinib, with chemotherapy regimens selected at the investigator's discretion based on tumor type and clinical condition. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety.
Trial Details
NCT Number NCT07053150
Lead Sponsor Tongji Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd., Innovent Biologics (Suzhou) Co. Ltd.
Conditions Advanced Digestive System Tumor
Enrollment 80 participants
Start Date 2025-08-15
Primary Completion 2030-12-31 (estimated)
Study Completion 2031-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-08