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Could a single drug replace surgery for rectal cancer?

NCT ID NCT07740720

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study tests whether giving the immunotherapy drug dostarlimab for a longer period can completely eliminate tumors in people with a specific genetic type of rectal cancer. Participants have stage II or III rectal cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). The goal is to see if more people achieve a complete response, avoiding the need for chemotherapy, radiation, or surgery. Doctors will monitor tumor disappearance and how long the cancer stays under control.

What this could mean

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

Active substance
dostarlimab, an immunotherapy drug
What this could lead to
If successful, this could offer a way to cure certain rectal cancers without the need for chemotherapy, radiation, or surgery, preserving quality of life.
What could go wrong
The trial is still in phase 3b and results are not guaranteed. Some participants may not respond fully, and immunotherapy can cause side effects. Longer treatment may not improve outcomes for everyone.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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: * Has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+) locally advanced rectal adenocarcinoma. * Has radiologically and endoscopically evaluable disease. * Has a tumor demonstrating the presence of either: 1. dMMR status; MMR status must be assessed by immunohistochemistry for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR; MMR status will be determined locally; or 2. MSI-H phenotype as determined by polymerase chain reaction or by tissue next generation sequencing; MSI-H will be determined locally. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has adequate organ function. Exclusion Criteria: * Has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. * Has a tumor that, in the investigator's judgment, is causing symptomatic bowel obstruction or otherwise requires urgent/emergent local intervention. Participants with a history of bowel obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning colostomy). Patients with a history of bowel obstruction in the context of current rectal cancer diagnosis and treated with stenting are not eligible. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment. * Is receiving any other anticancer or experimental therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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