About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.;
Trial design
Treatments tested in this trial
- Sintilimab monotherapy
Treatment groups
Locations
Sponsors and collaborators
Wang Jianliu
Lead sponsor
Peking University People's Hospital
Sponsor institution
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator