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Can an immunotherapy drug replace surgery for some endometrial cancers?

NCT ID NCT07731607

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether the immunotherapy drug sintilimab can eliminate early-stage (I-II) MSI-H/dMMR endometrial cancer without the need for surgery. About 48 participants will receive sintilimab alone every three weeks. The goal is to see if the drug can produce a complete response, meaning no cancer remains on imaging or biopsy.

What this could mean

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

Active substance
an immunotherapy drug called sintilimab
What this could lead to
If it works, this could offer a way to treat early-stage endometrial cancer without surgery, preserving fertility and avoiding surgical risks.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. Immunotherapies can cause immune-related side effects, and not all patients may respond.

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

About 48 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

Sex

Female participants only

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. Aged 18-75 years. 2. Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma. 3. Laboratory-confirmed dMMR (mismatch repair deficient) endometrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS). 4. Stage I-II according to the FIGO 2023 staging system. 5. At least one measurable lesion (RECIST 1.1 criteria). 6. ECOG performance status 0-1, with a life expectancy of ≥12 months. 7. Strong desire for uterine preservation, conservative treatment, or fertility preservation, or inability to tolerate standard surgery due to comorbidities. 8. Adequate organ function within 14 days prior to enrollment. 9. Good follow-up conditions and signed informed consent. Exclusion Criteria: 1. Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents; 2. Prior treatment with immune checkpoint inhibitors; 3. Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.; 4. Concurrent severe dysfunction of vital organs including heart, lung, liver and kidney: alanine aminotransferase/aspartate aminotransferase elevated more than 3 times the upper limit of normal (ULN) and unresponsive to liver-protective therapy; serum creatinine ≥1.5 × ULN; abnormal thyroid function; history of heart failure, unstable angina pectoris, severe arrhythmia, myocarditis, interstitial lung disease, non-infectious pneumonitis or active pulmonary infection, etc.; 5. Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.); 6. Known hypersensitivity to any component of the study drug; 7. Pregnant or breastfeeding women; 8. Any severe or unstable concomitant disease that, in the investigator's judgment, renders the subject ineligible for this study.

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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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