Advanced Colorectal CancerPhase 2NCT07656766
Sintilimab Plus Gossypol Acetate in Advanced Colorectal Cancer
A Phase 2 study testing Sintilimab and Gossypol Acetate in people with Advanced Colorectal Cancer, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Sintilimab and Gossypol Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 15 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Treatment with systemic immunosuppressive medications within 2 weeks before initiation of study treatment, except protocol-allowed medications.
- Prior allogeneic stem cell transplantation or solid organ transplantation.
- 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.
- 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.
- Receipt of any other investigational drug within 28 days before initiation of study treatment.
- Known contraindication, hypersensitivity, or severe allergic reaction to any study drug or its excipients.
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 5 months after the last dose of sintilimab.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking University People's Hospital, +86 18883886902, shenzhanlong@pkuph.edu.cn
Zhanlong Shen, M.D.
About this study
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
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
- Being tested
- Sintilimab, Gossypol Acetate
- Keywords
- colorectal cancer, metastatic colorectal cancer, pMMR/MSS, sintilimab, PD-1 inhibitor, gossypol acetate, LRPPRC, immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308, PD-1 inhibitor
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.
Gossypol AcetateDrug
Also called Compound Gossypol Acetate Tablet
Gossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Sintilimab Plus Gossypol Acetate | Experimental | Participants will receive oral gossypol acetate and intravenous sintilimab according to the study protocol. Receives: Drug: Sintilimab; Drug: Gossypol Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 11 after initiation of study treatment
Secondary outcomes (5)
Disease Control Rate
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.
Measured: At Week 11 after initiation of study treatment
Progression-Free Survival
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.
Measured: From the first dose of study treatment up to 24 months
Overall Survival
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Measured: From the first dose of study treatment up to 24 months
Duration of Response
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.
Measured: From the first documented response up to 24 months
Adverse events (AEs) were graded according to the NCI CTCAE version 5.0
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.
Measured: From the first dose of study treatment through 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive sintilimab in combination with oral gossypol acetate.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zhanlong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656766
- Sponsor's protocol ID
- 2025PHD051-001
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07656766
- Acronym / sponsor ID
- 2025PHD051-001
- Conditions
- Advanced Colorectal Cancer
- Keywords
- colorectal cancer, metastatic colorectal cancer, pMMR/MSS, sintilimab, PD-1 inhibitor, gossypol acetate, LRPPRC, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive sintilimab in combination with oral gossypol acetate.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sintilimab Plus Gossypol Acetate | Experimental | Drug: Sintilimab, Drug: Gossypol AcetateParticipants will receive oral gossypol acetate and intravenous sintilimab according to the study protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabAlso: IBI308, PD-1 inhibitorSintilimab 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 | Experimental: Sintilimab Plus Gossypol Acetate |
| Gossypol AcetateAlso: Compound Gossypol Acetate TabletGossypol acetate 20 mg will be administered orally once daily after dinner for 9 weeks, according to the study protocol. | Drug | Experimental: Sintilimab Plus Gossypol Acetate |
Primary outcome
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.
5 secondary outcomes
Disease Control Rate
Time frame: At Week 11 after initiation of study treatment
Progression-Free Survival
Time frame: 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
Duration of Response
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab and Gossypol Acetate in people with Advanced Colorectal Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziwei Zhang (+86 18883886902, 786327832@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: At Week 11 after initiation of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.