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Immunotherapy shows promise for untreated rectal cancer in chinese patients

NCT ID NCT06640049

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a drug called dostarlimab in 23 Chinese patients with a specific type of advanced rectal cancer (dMMR/MSI-H) that has not been treated before. The goal is to see if the drug can make the cancer disappear completely and stay gone for at least 12 months. Patients receive the drug alone, without chemotherapy or radiation.

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

23 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Apr 2031

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: * Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma * Participant has radiologically and endoscopically evaluable disease * Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment Exclusion Criteria: * Participant has distant metastatic disease * Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer * Has a known additional malignancy that progressed or required active treatment within the past 2 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-related severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade \[SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary * Has any history of interstitial lung disease or pneumonitis * Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant) * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients

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Conditions

The condition(s) this trial relates to.

rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Neoplasms, rectal

Contacts and locations

Locations

  • GSK Investigational Site

    Chengdu, 610041, China

  • GSK Investigational Site

    Chongqing, 400010, China

  • GSK Investigational Site

    Guangzhou, 510060, China

  • GSK Investigational Site

    Guangzhou, 510655, China

  • GSK Investigational Site

    Hangzhou, 310016, China

  • GSK Investigational Site

    Hangzhou, China

  • GSK Investigational Site

    Jinan, 250117, China

  • GSK Investigational Site

    Kunming, 650106, China

  • GSK Investigational Site

    Shanghai, 200032, China

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