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

NCT05890742 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-03-15

No results posted yet for this study

Summary

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2028-04-15
Completion
2028-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05890742 on ClinicalTrials.gov