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ACTIVE NOT RECRUITING
NCT04556253
PHASE2

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

Sponsor: Peking University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-Label, Phase II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 in the Perioperative Treatment of Locally Advanced Microsatellite Instability/Mismatch Repair Protein-Deficient Gastric and Colorectal Cancers

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

47

Start Date

2024-02-28

Completion Date

2028-12

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

DRUG

AK104

Subjects will receive AK104 by intravenous administration.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China