Efficacy and Safety of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Advanced Stage HCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,244
- 试验地点
- 3
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies in patients with advanced-stage hepatocellular carcinoma (HCC).
详细描述
Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with advanced-stage HCC. This real-world study also would like to explore the optimal combined treatment and subgroup of HCC patients for providing further information for clinical practice and trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- •Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
- •Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- •Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- •TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
- •Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
- •Has repeated measurable intrahepatic lesions;
排除标准
- •Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- •Unable to meet criteria of combination timeframe described above;
研究组 & 干预措施
Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
干预措施: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab (Drug)
Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
干预措施: TACE (Procedure)
Control group: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
干预措施: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
次要结局
- Objective response rate(ORR) per RESCIST 1.1(up to approximately 2 years)
- Disease Control Rate (DCR) per RESCIST 1.1(up to approximately 2 years)
- DOR per mRECIST(up to approximately 2 years)
- Duration of Response (DOR) per RESCIST 1.1(up to approximately 2 years)
- Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(up to approximately 2 years)
- PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)(up to approximately 2 years)
- ORR per mRECIST(up to approximately 2 years)
- DCR per mRECIST(up to approximately 2 years)
- Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0(up to approximately 2 years)
研究者
Gao-jun Teng
President
Zhongda Hospital