A Randomized Controlled Trial of Radical Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Adjuvant Systemic Chemotherapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- recurrence free survival
研究概览
简要总结
The purpose of this study is to determine that adjuvant systemic chemotherapy is superior to adjuvant transcatheter arterial chemoembolization(TACE) in prolonging recurrence free survival（RFS） in patients after radical resection of hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •a preoperative diagnosis of HCC with no previous treatment;
- •compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
- •multiple tumors more than 5 cm or tumor involving a major branch (the Wrstor second branch) of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasonography and gross examination of the liver during operation;
- •on exploration and intraoperative ultrasonography, the tumor with multiple lesions localized in right or left hemiliver,or the main tumor localized in one lobe only with a small solitary lesion in contralateral lobe, or tumor involving a major branch (the Wrst or second branch) of the portal or hepatic vein(s), which could be safely resected without grossly remaining tumors, and the patient was judged to have well preserved liver function to survive the operation.
- •Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin<1.5×ULN, international normalized ratio <1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. Patients with AST and ALT<5 ×ULN could be recruited if total bilirubin was in the normal range.
排除标准
- •documented allergy to study drugs; any previous TACE or systemic chemotherapy treatment before random assignment;
- •concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion);
- •CNS metastasis;
- •Other serious illness or medical condition.
研究组 & 干预措施
systemic chemotherapy
Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks within 4-6 weeks after hepatic resection(a total of 4 cycles).
干预措施: systemic chemotherapy (Drug)
Transcatheter Arterial Chemoembolization
Transcatheter Arterial Chemoembolization (Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou)) within 4-6 weeks after hepatic resection(a total of 1 cycle).
干预措施: Transcatheter Arterial Chemoembolization (Drug)
结局指标
主要结局
recurrence free survival
时间窗: 6 months
次要结局
- Overall survival(3 months and 24 months)
- Time to Recurrence(6 months and 12 months)
- Time to Recurrence within liver(3 months and 12 months)
- Time of tumor distant metastasis(3 months and 12 months)
研究者
Chengcheng Liao
Director, Principal Investigator, Clinical Professor
Guangxi Medical University