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New drug duo shows promise against aggressive colon cancer

NCT ID NCT05890742

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving two immunotherapy drugs (IBI310 and sintilimab) before surgery can eliminate or shrink tumors in people with a specific genetic type of colon cancer (MSI-H/dMMR). About 453 adults with stage IIB or III colon cancer that can be surgically removed will receive the drug combination before their operation. The main goals are to see if the cancer completely disappears after treatment and to measure how long patients remain cancer-free.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

453 people

The number who actually took part.

Started

May 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed the Informed Consent Form (ICF) and complied with the visit and related procedures stipulated by the plan; 2. At least 18 years old. 3. Primary colon adenocarcinoma was histologically confirmed. 4. Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only). 5. MSI-H or dMMR. 6. Radical excision can be performed before neoadjuvant therapy after diagnosis by the investigator. 7. Have at least one evaluable lesion according to the RECIST v1.1 evaluation criteria. 8. The Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 to 1. Exclusion Criteria: 1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. 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. 3. 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. 4. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Msi-H

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.