Not Yet RecruitingPhase 2

Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer

48 participantsStarted 2026-07-20

Plain-language summary

To investigate the efficacy and safety of immune checkpoint inhibitors as a non-surgical (surgery-avoiding) treatment in patients with stage I-II MSI-H/dMMR endometrial cancer.

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 18-75 years.
. Histopathologically confirmed endometrial cancer, with pathological types including endometrioid, serous, clear cell, undifferentiated, dedifferentiated, or carcinosarcoma.
. 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).
. Stage I-II according to the FIGO 2023 staging system.
. At least one measurable lesion (RECIST 1.1 criteria).
. ECOG performance status 0-1, with a life expectancy of ≥12 months.
. Strong desire for uterine preservation, conservative treatment, or fertility preservation, or inability to tolerate standard surgery due to comorbidities.
. Adequate organ function within 14 days prior to enrollment.

Exclusion criteria

. Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;
. Prior treatment with immune checkpoint inhibitors;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)

Timeframe: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)

Trial details

NCT IDNCT07731607

SponsorWang Jianliu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07-20

Contact for this trial

Linlin Bo, Doctor

86+18811552683 bo_lin_lin@163.com

View on ClinicalTrials.gov More MMRd Endometrial Cancer of Stage I~II trials