Can an immunotherapy drug replace surgery for some endometrial cancers?
NCT ID NCT07731607
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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