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NOT YET RECRUITING
NCT07656766
PHASE2

Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, single-arm, exploratory phase II clinical trial designed to evaluate the preliminary efficacy and safety of sintilimab in combination with oral gossypol acetate in patients with advanced pMMR/MSS colorectal cancer after failure of at least two prior lines of standard therapy. Eligible participants will have histologically or cytologically confirmed advanced colorectal adenocarcinoma, measurable disease according to RECIST version 1.1, ECOG performance status of 0 or 1, and adequate organ function. Participants will receive oral gossypol acetate once daily, followed by sintilimab administered intravenously every 3 weeks after a gossypol acetate lead-in period. The primary outcome is objective response rate assessed by RECIST version 1.1. Secondary outcomes include disease control rate, progression-free survival, overall survival, duration of response, and safety.

Official title: A Single-Arm, Open-Label, Exploratory Phase II Clinical Trial of Sintilimab Plus Gossypol Acetate in Patients With Advanced pMMR/MSS Colorectal Cancer After Failure of at Least Two Prior Lines of Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-07-15

Completion Date

2029-09-15

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab 200 mg will be administered intravenously every 3 weeks for 3 cycles after a gossypol acetate lead-in period, according to the study protocol.

DRUG

Gossypol Acetate

Gossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China