Safety and Efficacy of External Beam Radiation Plus Transarterial Chemoembolization and Lenvatinib vs Transarterial Chemoembolization and Lenvatinib in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years;
- •histologically or cytologically or clinically confirmed diagnosis of HCC;
- •presenting with PVTT and at least one measurable intrahepatic lesion on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); an intrahepatic lesion consisting of a single tumor (≤ 10.0 cm) or multiple tumors (≤ 3 foci) with the tumor burden < 50%;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Child-Pugh class A or B;
- •life expectancy of at least 3 months;
- •satisfactory blood, liver, and kidney function parameters. The acceptable blood, liver, and kidney parameters were (1) neutrophil count ≥ 1.5 × 109/L; (2) platelet count ≥ 60 × 109/L; (3) hemoglobin concentration ≥ 90 g/L; (4) serum albumin concentration ≥ 30 g/L; (5) bilirubin ≤ 50 μmol/L; (6) AST and ALT < 5 × upper limit of normal (ULN) and alkaline phosphatase < 4 × ULN; (7) extended prothrombin time < 6 seconds of ULN; and (8) serum creatinine < 1.5 × ULN.
排除标准
- •history of liver and adjacent tissue radiation;
- •medical history of hepatic decompensation, such as hepatic encephalopathy and esophageal or gastric variceal bleeding;
- •extrahepatic spread;
- •combination with other malignant diseases;
- •contraindications for TACE;
- •pregnant and lactating women;
- •severe dysfunction of the heart, kidney, or other organs;
- •hypersensitivity to intravenous contrast agents;
- •with HIV, syphilis infection;
- •allogeneic organ transplant recipients;
- •suffering from mental and psychological diseases may affect informed consent;
- •unable to take oral medication;
- •active gastric or duodenal ulcers within 3 months before enrollment.
研究组 & 干预措施
RT+TACE+Lenvatinib
Patients in RT+TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib. RT will begin within 4 weeks after the first TACE.
干预措施: Lenvatinib (Drug)
RT+TACE+Lenvatinib
Patients in RT+TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib. RT will begin within 4 weeks after the first TACE.
干预措施: TACE (Procedure)
RT+TACE+Lenvatinib
Patients in RT+TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib. RT will begin within 4 weeks after the first TACE.
干预措施: External beam radiation (RT) (Radiation)
TACE+Lenvatinib
Patients in TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib.
干预措施: Lenvatinib (Drug)
TACE+Lenvatinib
Patients in TACE+Lenvatinib group will take oral lenvatinib first and receive TACE one day after oral administration of lenvatinib.
干预措施: TACE (Procedure)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 2 years
OS is defined as the time from the first day of lenvatinib oral administration to death, regardless of disease recurrence.
次要结局
- Progression-Free Survival (PFS)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- ncidence of Adverse Events (AE)(Up to 2 years)
研究者
Ming Kuang
Professor
Sun Yat-sen University