797TiP - Tislelizumab combined with chemotherapy as neoadjuvant treatment for advanced endometrial cancer: A prospective, single-arm, open-label clinical study

Background

Surgery is the primary treatment for advanced endometrial cancer. Patients with no visible lesions have a better prognosis. Conventional preoperative neoadjuvant chemotherapy does not achieve a satisfactory R0 rate. The NCCN Guidelines for Uterine Neoplasms indicates that the incorporation of immunotherapy into the initial treatment regimen (carboplatin/paclitaxel) for advanced or recurrent endometrial cancer markedly enhances patient outcomes, irrespective of MMR status. This study aims to assess the efficacy of tislelizumab in conjunction with carboplatin/paclitaxel as a neoadjuvant treatment for advanced endometrial cancer. It is hypothesised that this treatment will improve the surgical R0 rate and reduce distant metastasis and disease recurrence in this patient population.

Trial design

This is a prospective, open-label, multicentre, single-arm study that aims to enroll 20 patients with previously untreated 2023 FIGO staging for endometrial cancer (III-IVb). Patients will receive tislelizumab (200 mg) in combination with carboplatin (AUC5)/paclitaxel (175 mg/m²) every three weeks, for two to four cycles. The number of treatment cycles may be adjusted by the investigator based on clinical practice. Surgery will be performed after neoadjuvant therapy achieves complete response (CR), partial response (PR), or stable disease (SD). Patients will receive maintenance therapy based on the investigator's choice. The primary endpoint of the study is the R0 rate. Secondary observational endpoints include pathological complete response (pCR)%, objective response rate (ORR), recurrence-free survival (RFS), progress-free survival (PFS), overall survival (OS), and safety. Adverse events are monitored according to the NCI CTCAE, Version 5.0. The estimated study duration is 18 months.

Clinical trial identification

NCT06363708.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.