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

NCT06363708 | Not Yet Recruiting

• 1 other identifier: 2024050
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometrial Neoplasms

Keywords

Oncology; Endometrial Cancer; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• R0 resection rate (R0 %)

  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.

  Up to approximately 24 months

Secondary Outcomes (6)

• Pathological complete response rate (pCR%）

  Up to approximately 24 months

• Objective Response Rate (ORR%)

  Up to approximately 24 months

• Progression free survival (PFS)

  Up to approximately 24 months

• Recurrence free survival (RFS)

  Up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months

Study Arms (1)

Tislelizumab+Carboplatin+Paclitaxel

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Tislelizumab DRUG

Tislelizumab 200mg D1 ,Q3W

Tislelizumab+Carboplatin+Paclitaxel

Paclitaxel DRUG

Paclitaxel(175 mg/m2 ) D1,Q3W

Tislelizumab+Carboplatin+Paclitaxel

Carboplatin DRUG

Carboplatin(AUC=5) D1,Q3W

Tislelizumab+Carboplatin+Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and signed informed consent form;
• Age ≥18 years;
• Eastern Cooperative Oncology Group performance status 0-1;
• The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;
• Has not received any systematic anti-tumor treatment for advanced diseases in the past;
• Have measurable disease according to RECIST v1.1 criteria;
• 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
• The expected lifespan exceeds 3 months.

You may not qualify if:

• 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；
• Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection；
• Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;
• Major surgical procedures had been performed within 4 weeks before consent was obtained；
• Other conditions deemed by the investigator to be ineligible for enrollment.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (3)

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430062, China

Location

Hubei maternal and child health care hospital

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms

Interventions

tislelizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Zheng Hu, MD,PhD

  Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Hu, MD,PhD

CONTACT

13632120686; Huzheng1988@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)