Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.
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
- •The patient voluntarily participates and signs informed consent
- •Aged 18 years of age or older
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
- •Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
- •Willing to accept concurrent radiotherapy combined with Tislelizumab
- •Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
- •Has adequate organ function
- •Has expected survival time ≥3 months
排除标准
- •Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
- •Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
- •Has received a major surgery within 4 weeks prior to signing informed consent
- •Not suitable for radiotherapy
- •Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
- •Did not meet the other requirements for inclusion by the investigator
- •Judged unqualified of the enrollment requirements by the researcher according to other conditions
结局指标
主要结局
Objective Response Rate
时间窗: 12 months
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
次要结局
- Overall survival(24 months)
- Progression-free survival (PFS)(12 months)
- Adverse Events(24 months)
研究者
Lei Li
Professor
Peking Union Medical College Hospital