Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer

NCT07731607 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026PHB254-001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

MMRd Endometrial Cancer of Stage I~II

Keywords

endometrial cancer; stage I~II; MMRd

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of the cycle 4 or cycle 8 (each cycle is 21 days)

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug: Sintilimab monotherapy

Interventions

Sintilimab monotherapy DRUG

Sintilimab monotherapy 200mg，Q3W

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wang Jianliu: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Linlin Bo, Doctor

CONTACT

86+18811552683; bo_lin_lin@163.com

Yiqin Wang, Doctor

CONTACT

emily_wang92@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Institute of Obstetrics and Gynecology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2030
• Study Completion (Estimated): July 20, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share