Tislelizumab Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Endometrial Cancer : A Prospective, Single-arm, Open-label Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- R0 resection rate (R0 %)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tislelizumab+Carboplatin+Paclitaxel
Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle
干预措施: Tislelizumab (Drug)
Tislelizumab+Carboplatin+Paclitaxel
Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle
干预措施: Paclitaxel (Drug)
Tislelizumab+Carboplatin+Paclitaxel
Tislelizumab 200mg D1 +Carboplatin(AUC=5) D1+Paclitaxel(175 mg/m2 ) D1, every 3 weeks (21 days) is a treatment cycle
干预措施: Carboplatin (Drug)
结局指标
主要结局
R0 resection rate (R0 %)
时间窗: 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.
次要结局
- 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)
- Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0(Up to approximately 24 months)
- Pathological complete response rate (pCR%）(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)