Not yet recruiting NCT07731607
Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sintilimab monotherapy.
- Who it may be relevant to
- Registry conditions: MMRd Endometrial Cancer of Stage I~II. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Sintilimab monotherapy
Sintilimab monotherapy 200mg，Q3W
Primary outcome measures
- Complete Response Rate (cCR by imaging in non-surgical pts + pCR in surgical pts) [Time frame: at the end of the cycle 4 or cycle 8 (each cycle is 21 days)]
Eligibility criteria
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.
- Good follow-up conditions and signed informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07731607 · 2026PHB254-001