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Immunotherapy drug shows promise before colon cancer surgery

NCT ID NCT05116085

Disease control Sponsor: BeiGene 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug tislelizumab given before surgery in 33 people with early-stage colorectal cancer that has specific genetic changes (MSI-H or dMMR). The goal was to see if the drug could shrink or eliminate tumors before surgical removal. The trial has completed, and results will show how many patients had a major or complete response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (an immunotherapy drug given by IV)
What this could lead to
If successful, this could lead to a new treatment option that shrinks tumors before surgery, potentially improving outcomes for people with this specific type of colorectal cancer.
What could go wrong
This is a small, early-phase trial with only 33 participants, so results may not apply to everyone. The drug may cause side effects or not work as well in larger, more diverse groups.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

33 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2025

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: * Participants had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Participants had a pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III colon or rectal cancer (CRC) with microsatellite instability-high (MSI-H) status confirmed by a sponsor-designated central laboratory, or known MSI-H status confirmed by a local laboratory. Participants were required to be eligible for complete surgical removal of the tumor (R0 resection) with curative intent. * Participants had evaluable or measurable disease as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. * Participants had adequate blood counts and organ function, as defined by protocol-specified laboratory test results obtained within 7 days before the first dose of study treatment. Exclusion Criteria: * Participants had received any prior treatment for their current colorectal cancer, including chemotherapy, radiotherapy, or immunotherapy. * Participants had any condition requiring systemic treatment with corticosteroids at doses greater than 10 milligrams (mg) of prednisone per day, or other immunosuppressive medications within 14 days before the first dose. * Participants had active autoimmune diseases or a history of autoimmune diseases that could potentially relapse. Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal cancer

Contacts and locations

Locations

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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