MSI-HPhase 3NCT05890742
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
A Phase 3 study testing Sintilimab, IBI310&Sintilimab and Radical surgery in people with MSI-H, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MSI-H
- What is being tested?
- Sintilimab, IBI310&Sintilimab and Radical surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2023to 15 Jul 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
- At least 18 years old.
- Primary colon adenocarcinoma was histologically confirmed.
- Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
- MSI-H or dMMR.
- Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator.
- Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria.
- The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1.
Who cannot join
- Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
- Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
- Conditions
- MSI-H
- Being tested
- Sintilimab, IBI310&Sintilimab, Radical surgery
- Keywords
- dMMR, resectable colon cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
In ARM Phase Ib Control group, Sintilimab will be used twice, q3w.
IBI310&SintilimabDrug
In ARM Phase Ib\&III Experimental group，IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy.
Radical surgeryProcedure or surgery
In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib Experimental group | Experimental | In Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer. Receives: Drug: IBI310&Sintilimab; Procedure: Radical surgery |
| Phase Ib Control group | Active comparator | In Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer. Receives: Drug: Sintilimab; Procedure: Radical surgery |
| Phase III Experimental group | Experimental | In Phase III Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. Receives: Drug: IBI310&Sintilimab |
| Phase III Control group | Active comparator | In Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. Receives: Procedure: Radical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Measured: 1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
Measured: up to 5 years after surgery
Secondary outcomes (2)
R0 tumor resection rate, defined as the proportion of subjects with R0 excision
The proportion of subjects with R0 excision
Measured: 2 week after surgery
Overall-survival(OS), defined as the time from randomization to death from any cause
The time from randomization to death from any cause
Measured: up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start25 May 2023
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-HStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890742
- Sponsor's protocol ID
- CIBI310L301
- Status last verified
- May 2026
- First submitted
- 26 May 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
- ClinicalTrials.gov ID
- NCT05890742
- Acronym / sponsor ID
- CIBI310L301
- Conditions
- MSI-H
- Keywords
- dMMR, resectable colon cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 6 Jun 2023 (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.
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ib Experimental group | Experimental | Drug: IBI310&Sintilimab, Procedure: Radical surgeryIn Phase Ib Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only.Followed by radical surgery for colon cancer. |
| Phase Ib Control group | Active comparator | Drug: Sintilimab, Procedure: Radical surgeryIn Phase Ib Control group，subjects will receive two cycles of neoadjuvant immunotherapy with 200 mg of sintilimab per cycle, followed by radical surgery for colon cancer. |
| Phase III Experimental group | Experimental | Drug: IBI310&SintilimabIn Phase III Experimental group，subjects will receive two cycles of neoadjuvant immunotherapy: the first cycle of IBI310 (1mg/kg) \& Sintilimab (200mg) and the second cycle of Sintilimab (200mg) only. Followed by radical surgery for colon cancer. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. |
| Phase III Control group | Active comparator | Procedure: Radical surgeryIn Phase III Control group, subjects will receive radical surgery without neoadjuvant therapy. Adjuvant chemotherapy will be given or not according to the pathological stage after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan;
- At least 18 years old.
- Primary colon adenocarcinoma was histologically confirmed.
- Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
- MSI-H or dMMR.
Key exclusion criteria (4 listed)
- Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) or any other drug acting on T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cellular immunotherapy.
- Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.
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 |
|---|---|---|
| SintilimabIn ARM Phase Ib Control group, Sintilimab will be used twice, q3w. | Drug | Phase Ib Control group |
| IBI310&SintilimabIn ARM Phase Ib\&III Experimental group，IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy. | Drug | Phase III Experimental group, Phase Ib Experimental group |
| Radical surgeryIn ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy | Procedure or surgery | Phase III Control group, Phase Ib Control group, Phase Ib Experimental group |
Primary outcome
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Time frame: 1 month after surgery
The proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy.
Event Free Survival, EFS(EFS), defined as the time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
Time frame: up to 5 years after surgery
The time from randomization to the first determination using RECIST v1.1 of inoperable disease progression, local recurrence or distant metastasis after surgery, or death from any cause, whichever occurs first.
2 secondary outcomes
R0 tumor resection rate, defined as the proportion of subjects with R0 excision
Time frame: 2 week after surgery
Overall-survival(OS), defined as the time from randomization to death from any cause
Time frame: up to 5 years after surgery
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 28 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab, IBI310&Sintilimab and Radical surgery in people with MSI-H, run by Innovent Biologics (Suzhou) Co. Ltd. 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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. 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 28 May 2026.