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Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer

NCT07656766 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • Advanced Colorectal Cancer

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-09-15
Completion
2029-09-15

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 NCT07656766 on ClinicalTrials.gov