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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Sintilimab monotherapy
DrugSintilimab monotherapy 200mg,Q3W
Treatment groups
Trial outcomes
Primary outcomes
Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts)
Clinical Complete Response (cCR): Defined as the complete disappearance of all target lesions as assessed by imaging in subjects who did not undergo surgery, with no appearance of new lesions; or the absence of residual tumor cells in endometrial biopsy specimens obtained under hysteroscopy. Pathological Complete Response(pCR): Defined as the absence of residual tumor cells in the surgically resected tumor tissue specimens from subjects who underwent hysterectomy.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wang Jianliu
Lead sponsor
Peking University People's Hospital
Sponsor institution
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: