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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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This is a multicenter, prospective, single-arm open-label study designed to enhance surgical R0 resection rate, reduce residual lesions, decrease distant metastasis and disease recurrence rates, and prolong the survival of patients with advanced endometrial cancer (stage III-IVb FIGO 2023) by neoadjuvant chemotherapy combined with tislelizumab.

Conditions

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Endometrial Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tislelizumab+Carboplatin+Paclitaxel

Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab 200mg D1 ,Q3W

Paclitaxel

Intervention Type DRUG

Paclitaxel(175 mg/m2 ) D1,Q3W

Carboplatin

Intervention Type DRUG

Carboplatin(AUC=5) D1,Q3W

Interventions

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Tislelizumab

Tislelizumab 200mg D1 ,Q3W

Intervention Type DRUG

Paclitaxel

Paclitaxel(175 mg/m2 ) D1,Q3W

Intervention Type DRUG

Carboplatin

Carboplatin(AUC=5) D1,Q3W

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No