The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1-year survival rate
研究概览
简要总结
According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Child-Pugh score≤ 7
- •HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
- •the primary HCC being in BCLC C stage according to NCCN guideline
- •No previous systemic therapy for HCC
排除标准
- •Diffuse HCC
- •Uncontrolled ascites of hepatic encephalopathy
- •Prior liver transplantation
- •Positive for human immunodeficiency virus
- •Active gastric or duodenal ulcer
- •Other uncontrolled comorbidities or malignancy
研究组 & 干预措施
TACE combined Tilelizumab and Sorafenib
TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)
干预措施: TACE (Procedure)
TACE combined Tilelizumab and Sorafenib
TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)
干预措施: Tilelizumab (Drug)
TACE combined Tilelizumab and Sorafenib
TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally)
干预措施: Sorafenib (Drug)
结局指标
主要结局
1-year survival rate
时间窗: at 1 year after enrolled
1-year survival rate assessed by Kaplan-Meier analysis
次要结局
- Progression free survival(at 12 weeks and up to 2 years after enrolled)
- Objective response rate(at 12 weeks and up to 2 years after enrolled)
- Disease control rate(at 12 weeks and up to 2 years after enrolled)
- Time to progression(at 12 weeks and up to 2 years after enrolled)