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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWang Jianliu

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

Qualifiers

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

Treatments tested in this trial

  • Sintilimab monotherapy

Treatment groups

48 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Wang Jianliu

Lead sponsor

Peking University People's Hospital

Sponsor institution

Innovent Biologics (Suzhou) Co. Ltd.

Collaborator