Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
详细描述
This is an single center, randomized controlled trial to evaluate the efficacy and safety of TACE-Len-I compared with TACE-Len for the treatment of HCC with branch PVTT.
171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 between18 and 75 years.
- •HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
- •Accompanied with tumor thrombus involving unilateral portal vein branch.
- •Child-Pugh class A or B.
- •Eastern Cooperative Group performance status (ECOG) score of 0-
- •Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
- •Prothrombin time prolonged for less than 4s or international normalized ratio < 1.
- •Neutrophilic granulocyte count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L, and hemoglobin level ≥ 85g/L;
- •At least one measurable intrahepatic target lesion.
- •Life expectancy of at least 3 months.
排除标准
- •Diffuse HCC.
- •Extrahepatic metastasis.
- •Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
- •Hepatic vein and/or vena cava invasion.
- •History of organ or cells transplantation.
- •Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
- •History of other malignancies.
- •Serious medical comorbidities.
- •Female patients who are pregnancy or breastfeeding.
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years.
The time from date of randomization to death due to any cause.
次要结局
- Duration of portal patency(2 years.)
- Adverse events (AEs)(2 years.)
- Objective response rate (ORR) assessed by investigators according to mRECIST(2 years.)
- Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)(2 years.)
- Disease control rate (DCR) assessed by investigators according to mRECIST(2 years.)