Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 130 mg/m² Oxaliplatin, Leucovorin, and Fluorouracil Versus Sorafenib or Lenvatinib Plus Hepatic Artery Infusion of 85 mg/m² Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Advanced Hepatocellular Carcinoma: a Randomised Phase 3 Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.
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
- Triple (Participant, Care Provider, 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
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- •Patients must have at least one tumor lesion that can be accurately measured;
- •With vascular invasion or extrahepatic metastasis
- •Diagnosed as unresectable with consensus by the panel of liver surgery experts;
- •No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
- •≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
- •≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
- •Ability to understand the protocol and to agree to and sign a written informed consent document.
排除标准
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Evidence of bleeding diathesis.
- •Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
研究组 & 干预措施
OXA 130
Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
干预措施: HAIC of 130 mg/m² Oxaliplatin, and 5-fu (Drug)
OXA 130
Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
干预措施: TKI (Drug)
OXA 85
Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
干预措施: HAIC of 85 mg/m² Oxaliplatin, and 5-fu (Drug)
OXA 85
Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu
干预措施: TKI (Drug)
结局指标
主要结局
Overall survival
时间窗: 24 months
次要结局
- progression-free survival(24 months)
- time to response(12 months)
- objective response rate(6 months)
- Adverse Events(30 Days after HAIC)
研究者
Shi Ming
Proffessor
Sun Yat-sen University