Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.
详细描述
In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection 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 (within 3 months);
- •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;
- •Child-Pugh C or PS>2 or Severe hepatic encephalopathy
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
- 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)
- Objective response rate(ORR) per RESCIST 1.1(up to approximately 2 years)
- ORR per mRECIST(up to approximately 2 years)
- Duration of Response (DOR) per RESCIST 1.1(up to approximately 2 years)
- DOR per mRECIST(up to approximately 2 years)
- Disease Control Rate (DCR) per RESCIST 1.1(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