MMRd Endometrial Cancer of Stage I~II
Conditions
Keywords
endometrial cancer, stage I~II, MMRd
Brief 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.
Interventions
Sintilimab monotherapy 200mg，Q3W
Sponsors
Wang Jianliu
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts) | at the end of the cycle 4 or cycle 8 (each cycle is 21 days) | 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. |
Contacts
CONTACTLinlin Bo, Doctor
CONTACTYiqin Wang, Doctor
Outcome results
None listed