Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer

NCT07656766 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025PHD051-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colorectal cancer; metastatic colorectal cancer; pMMR/MSS; sintilimab; PD-1 inhibitor; gossypol acetate; LRPPRC; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate is defined as the proportion of participants who achieve complete response or partial response as their best overall response, as assessed according to RECIST version 1.1 by independent radiologic review.

  At Week 11 after initiation of study treatment

Secondary Outcomes (5)

• Disease Control Rate

  At Week 11 after initiation of study treatment

• Progression-Free Survival

  From the first dose of study treatment up to 24 months

• Overall Survival

  From the first dose of study treatment up to 24 months

• Duration of Response

  From the first documented response up to 24 months

• Adverse events (AEs) were graded according to the NCI CTCAE version 5.0

  From the first dose of study treatment through 30 days after the last dose of study treatment

Study Arms (1)

Experimental: Sintilimab Plus Gossypol Acetate

EXPERIMENTAL

Participants will receive oral gossypol acetate and intravenous sintilimab according to the study protocol.

Drug: Sintilimab; Drug: Gossypol Acetate

Interventions

Sintilimab DRUG

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.

Also known as: IBI308, PD-1 inhibitor

Experimental: Sintilimab Plus Gossypol Acetate

Gossypol Acetate DRUG

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

Also known as: Compound Gossypol Acetate Tablet

Experimental: Sintilimab Plus Gossypol Acetate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least one measurable lesion according to RECIST version 1.1.
• Adequate hematologic, hepatic, renal, coagulation, and organ function as defined in the protocol.
• Female participants of childbearing potential must have a negative pregnancy test before initiation of study treatment and agree to use effective contraception during the study and for the protocol-specified period after the last dose.

You may not qualify if:

• 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.
• Severe chronic or active infection within 4 weeks before initiation of study treatment.
• Active tuberculosis infection or inadequately treated prior active tuberculosis.
• Active hepatitis B or hepatitis C infection as defined by protocol criteria.
• Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
• History of leptomeningeal disease.
• Prior treatment with CD137 agonists, T-cell co-stimulatory agents, or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-TIGIT antibodies.
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives before initiation of study treatment, whichever is longer.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sintilimab; Immune Checkpoint Inhibitors; Gossypol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Sesquiterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ziwei Zhang

CONTACT

+86 18883886902; 786327832@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All enrolled participants will receive sintilimab in combination with oral gossypol acetate.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)