NCT05890742View on ClinicalTrials.gov

A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

May 25, 2023

Primary Completion Date

April 15, 2028

Study Completion Date

July 15, 2028

Conditions
MSI-H
Interventions
DRUG

Sintilimab

In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.

DRUG

IBI310&Sintilimab

In ARM Phase Ib\&III Experimental group，IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.

PROCEDURE

Radical surgery

In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY