Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

1. Voluntary participation and signed informed consent form;
2. Age ≥18 years;
3. Eastern Cooperative Oncology Group performance status 0-1;
4. The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;
5. Has not received any systematic anti-tumor treatment for advanced diseases in the past;
6. Have measurable disease according to RECIST v1.1 criteria;
7. Patients must meet the following criteria for laboratory tests to ensure adequate organ function:

   * ANC ≥1,500/mm3, or ≥1.5×109/L
   * Platelet count≥75,000/mm3 or 75 x 109/L
   * Hemoglobin≥9 g/dL or ≥5.6 mmol/L
   * Glomerular filtration rate estimated（eGFR） according to the Chronic Kidney Disease Epidemiology Collaborative Group formula （CKD-EPI EQ6）was≥40 mL/ 1.73m2
   * Serum total bilirubin ≤ 1.5x upper limit of normal range（ULN）
   * Both AST and ALT were ≤3 x ULN
8. The expected lifespan exceeds 3 months.

Exclusion Criteria:

1. Received PD-1 target therapy other than tislelizumab or other antibody or drug therapy that specifically targets T-cell costimulation or checkpoint channels within 6 months before enrollment；
2. Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection；
3. Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;
4. Major surgical procedures had been performed within 4 weeks before consent was obtained；
5. Other conditions deemed by the investigator to be ineligible for enrollment.

Outcome Measures

Locations

Linked Diseases