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

July 25, 2026 updated by: Wang Jianliu
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Drug: Sintilimab monotherapy
Sintilimab monotherapy 200mg，Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang Jianliu

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

July 20, 2030

Study Completion (Estimated)

July 20, 2030

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 25, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 25, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026PHB254-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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