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Trial Title:
Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer
NCT ID:
NCT06363708
Condition:
Endometrial Neoplasms
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Carboplatin
Tislelizumab
Conditions: Keywords:
Oncology
Endometrial Cancer
Tislelizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab 200mg D1 ,Q3W
Arm group label:
Tislelizumab+Carboplatin+Paclitaxel
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel(175 mg/m2 ) D1,Q3W
Arm group label:
Tislelizumab+Carboplatin+Paclitaxel
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin(AUC=5) D1,Q3W
Arm group label:
Tislelizumab+Carboplatin+Paclitaxel
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Central Hospital of Wuhan
Address:
City:
Wuhan
Zip:
430014
Country:
China
Contact:
Last name:
Xun Tian, MD,PhD
Phone:
15327205656
Email:
tianxun@126.com
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430062
Country:
China
Contact:
Last name:
Zheng Hu, MD,PhD
Phone:
13632120686
Email:
Huzheng1988@163.com
Facility:
Name:
Hubei maternal and child health care hospital
Address:
City:
Wuhan
Zip:
430070
Country:
China
Contact:
Last name:
QuanFu Ma, MD,PhD
Phone:
13728133014
Email:
dm626925@126.com
Start date:
June 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363708
