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

Not Applicable

Not yet recruiting

• Conditions: Endometrial Neoplasms
• Interventions: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT06363708
• Lead Sponsor: Zhongnan Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Study Start: 2024-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
R0 resection rate (R0 %)	Up to approximately 24 months	R0 resection rate is defined as the percentage of eligible patients that underwent a microscopically complete (or R0) resection. The resection is considered R0 if the inked margin is further than 1 mm distinct from any tumour cells.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR%)	Up to approximately 24 months	ORR (either confirmed complete response \[CR\] or partial response \[PR\]) based on RECIST 1.1 will be determined in participants who have measurable disease at study entry.
Progression free survival (PFS)	Up to approximately 24 months	PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause.
Recurrence free survival (RFS)	Up to approximately 24 months	RFS is defined as the time from metastasectomy until progression by RECIST 1.1 or death from any cause.
Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0	Up to approximately 24 months	Safety and tolerability
Pathological complete response rate (pCR%）	Up to approximately 24 months	pCR is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible.
Overall survival (OS)	Up to approximately 24 months	OS is defined as time from first dose of study intervention to death from any cause.

Trial Locations

Locations (3)

The Central Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Hubei maternal and child health care hospital; 🇨🇳 Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China