Efficacy and Safety of Transarterial Chemoembolization in Combination With Tislelizumab and Lenvatinib for Advanced Stage HCC (CHANCE2602)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 596
- 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 evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib 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. Tislelizumab is a PD-1 monoclonal antibody approved by the National Medical Products Administration (NMPA) of China for first-line and second-line treatment of patients with HCC. The purpose of this real-world study is to evaluate the safety and efficacy of TACE in combination with Tislelizumab and Lenvatinib in patients with advanced-stage HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients who meet the clinical diagnostic criteria for primary liver cancer;
- •Age ≥18 years at the time of HCC diagnosis;
- •Barcelona Clinic Liver Cancer (BCLC) stage C;
- •No prior systemic therapy for HCC (including chemotherapy, molecular targeted therapy, or immunotherapy);
- •Received treatment with tislelizumab and lenvatinib, with the interval between the first administration of the two drugs ≤1 week;
- •In the experimental group, TACE was performed within 3 months before or after treatment with tislelizumab and lenvatinib;
- •After TACE, patients received at least one cycle of combination therapy with tislelizumab and lenvatinib, including cTACE and DEB-TACE;
- •Child-Pugh class A5 to B7;
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- •At least one measurable intrahepatic lesion according to RECIST 1.1 criteria.
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma histological types;
- •Complete obstruction of the main portal vein with insufficient collateral compensation;
- •Uncontrollable ascites or hepatic encephalopathy;
- •Incomplete clinical data or missing essential information;
- •Presence of other primary malignant tumors in addition to the diagnosis of liver cancer;
- •Participation in other interventional studies prior to treatment;
- •Other conditions deemed unsuitable for inclusion by the investigators.
研究组 & 干预措施
Control group
Tislelizumab + Lenvatinib The interval between first use Tislelizumab and Lenvatinib ≤1 week；
Study group
TACE + Tislelizumab + Lenvatinib TACE was performed within 3 months before or after the first Tislelizumab /Lenvatinib treatment. The interval between first use Tislelizumab and Lenvatinib ≤1 week；
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 RECIST 1.1(up to approximately 2 years)
- PFS per mRECIST(up to approximately 2 years)
- Objective response rate(ORR) per RESCIST 1.1(up to approximately 2 years)
- Duration of Response (DOR) per RESCIST 1.1(up to approximately 2 years)
- Disease Control Rate (DCR) per RESCIST 1.1(up to approximately 2 years)
- ORR per mRECIST(up to approximately 2 years)
- DOR 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
Dr. Prof. , President
Zhongda Hospital