Active — Not RecruitingPhase 3

A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

China453 participantsStarted 2023-05-25

Plain-language summary

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

Who can participate

Age range

18 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

. 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.

Exclusion criteria

. 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.

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

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.

Timeframe: 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.

Timeframe: up to 5 years after surgery

Trial details

NCT IDNCT05890742

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-15

View on ClinicalTrials.gov More MSI-H trials