drugset
drugset / Trial / NCT07053150

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

NCT07053150 ↗

Phase 2 Not yet recruiting 80 enrolled Tongji Hospital Innovent Biologics (Suzhou) Co. Ltd. · collabJiangsu HengRui Medicine Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-15
Primary completion
2030-12-31
Completion
2031-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Pyrotinib Small molecule 400 mg Oral
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 50 mg Oral
Subject S-1 Small molecule 60 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

digestive system neoplasm