Clinical Trial

AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

Active, Not Recruiting Phase 2
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Summary
This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric adenocarcinoma and colorectal cancer during the perioperative period.Eligible patients will receive AK104 for three cycles before surgery and at most 6 months after surgery. The primary endpoint is the pathological complete response rate.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-09-14.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-12-27
Trial Details
NCT Number NCT04556253
Lead Sponsor Peking University
Conditions MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Enrollment 47 participants
Start Date 2024-02-28
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-02