Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer (NCT07656766) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer
China32 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent provided before any study-specific procedures.
. Age 18 to 75 years, male or female.
. Histologically or cytologically confirmed advanced colorectal adenocarcinoma.
. Confirmed pMMR/MSS tumor status. Participants without documented MSI/MMR status must undergo MSI or MMR testing during screening.
. Disease progression after at least two prior lines of standard therapy.
. Availability of tumor tissue suitable for pathological evaluation and biomarker analysis.
. ECOG performance status of 0 or 1 within 7 days before the first dose of study treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: At Week 11 after initiation of study treatment
. At least one measurable lesion according to RECIST version 1.1.
Exclusion criteria
. Histology of small cell carcinoma, squamous cell carcinoma, or mixed carcinoma.
. dMMR/MSI-H tumor status.
. Complete bowel obstruction or clinical conditions likely to progress to bowel obstruction.
. Suspected bowel perforation based on clinical symptoms or imaging.
. History of malignancy other than colorectal cancer within 3 years before screening, except malignancies with negligible risk of metastasis or death and treated with expected curative outcome.
. Active autoimmune disease, history of autoimmune disease, or immunodeficiency requiring systemic treatment, except protocol-allowed conditions.
. Significant cardiovascular disease within 3 months before initiation of study treatment, including New York Heart Association class II or higher heart disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina.
. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.