Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer

June 15, 2026 updated by: Shen Zhanlong, Peking University People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Zhanlong Shen, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent provided before any study-specific procedures.
  2. Age 18 to 75 years, male or female.
  3. Histologically or cytologically confirmed advanced colorectal adenocarcinoma.
  4. Confirmed pMMR/MSS tumor status. Participants without documented MSI/MMR status must undergo MSI or MMR testing during screening.
  5. Disease progression after at least two prior lines of standard therapy.
  6. Availability of tumor tissue suitable for pathological evaluation and biomarker analysis.
  7. ECOG performance status of 0 or 1 within 7 days before the first dose of study treatment.
  8. At least one measurable lesion according to RECIST version 1.1.
  9. Adequate hematologic, hepatic, renal, coagulation, and organ function as defined in the protocol.
  10. 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.

Exclusion Criteria:

  1. Histology of small cell carcinoma, squamous cell carcinoma, or mixed carcinoma.
  2. dMMR/MSI-H tumor status.
  3. Complete bowel obstruction or clinical conditions likely to progress to bowel obstruction.
  4. Suspected bowel perforation based on clinical symptoms or imaging.
  5. 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.
  6. Active autoimmune disease, history of autoimmune disease, or immunodeficiency requiring systemic treatment, except protocol-allowed conditions.
  7. 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.
  8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.
  9. Severe chronic or active infection within 4 weeks before initiation of study treatment.
  10. Active tuberculosis infection or inadequately treated prior active tuberculosis.
  11. Active hepatitis B or hepatitis C infection as defined by protocol criteria.
  12. Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  13. History of leptomeningeal disease.
  14. 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.
  15. Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives before initiation of study treatment, whichever is longer.
  16. Treatment with systemic immunosuppressive medications within 2 weeks before initiation of study treatment, except protocol-allowed medications.
  17. Prior allogeneic stem cell transplantation or solid organ transplantation.
  18. Receipt of a live attenuated vaccine within 4 weeks before initiation of study treatment or expected need for such vaccination during the study or within 5 months after the last dose of sintilimab.
  19. Major surgery or severe traumatic injury within 28 days before initiation of study treatment, abdominal surgery or abdominal intervention within 60 days before initiation of study treatment, or expected need for major surgery during the study.
  20. Receipt of any other investigational drug within 28 days before initiation of study treatment.
  21. Known contraindication, hypersensitivity, or severe allergic reaction to any study drug or its excipients.
  22. Pregnancy, breastfeeding, or intention to become pregnant during the study or within 5 months after the last dose of sintilimab.
  23. Any other disease, laboratory abnormality, social condition, or medical condition that, in the investigator's judgment, may compromise participant safety, interfere with study compliance, or affect interpretation of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Sintilimab Plus Gossypol Acetate
Participants will receive oral gossypol acetate and intravenous sintilimab according to the study protocol.
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.
Other Names:
  • IBI308
  • PD-1 inhibitor
Drug: Gossypol Acetate
Gossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol.
Other Names:
  • Compound Gossypol Acetate Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: At Week 11 after initiation of study treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate
Time Frame: At Week 11 after initiation of study treatment
Disease control rate is defined as the proportion of participants who achieve complete response, partial response, or stable disease as their best overall response according to RECIST version 1.1.
At Week 11 after initiation of study treatment
Progression-Free Survival
Time Frame: From the first dose of study treatment up to 24 months
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From the first dose of study treatment up to 24 months
Overall Survival
Time Frame: From the first dose of study treatment up to 24 months
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
From the first dose of study treatment up to 24 months
Duration of Response
Time Frame: From the first documented response up to 24 months
Duration of response is defined as the time from the first documented complete response or partial response to disease progression or death from any cause, whichever occurs first.
From the first documented response up to 24 months
Adverse events (AEs) were graded according to the NCI CTCAE version 5.0
Time Frame: From the first dose of study treatment through 30 days after the last dose of study treatment
Adverse events, serious adverse events, treatment-related adverse events, and immune-related adverse events will be assessed and graded according to NCI CTCAE version 5.0.
From the first dose of study treatment through 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025PHD051-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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