Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer
Starting soon · Phase 2
Conditions studied: MMRd Endometrial Cancer of Stage I~II
In brief
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.
Key facts
- Study ID
- NCT07731607
- Run by
- Wang Jianliu
- People needed
- 48
- Starts
- 2026-07-20
- Expected to finish
- 2030-07-20
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Good follow-up conditions and signed informed consent.
You may not qualify if…
- Presence of active autoimmune disease, or long-term requirement for immunosuppressive agents;
- Prior treatment with immune checkpoint inhibitors;
- Concurrent persistent or active infections, such as hepatitis B, hepatitis C, etc.;
- 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.;
- Other active malignant tumors (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
- Known hypersensitivity to any component of the study drug;
- Pregnant or breastfeeding women;
- Any severe or unstable concomitant disease that, in the investigator's judgment, renders the subject ineligible for this study.
Full record on ClinicalTrials.gov
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