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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sintilimab monotherapy

    Drug

    Sintilimab monotherapy 200mg,Q3W

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wang Jianliu

Lead sponsor

Peking University People's Hospital

Sponsor institution

Innovent Biologics (Suzhou) Co. Ltd.

Collaborator

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