NCT04667351Unknown3 期
Hepatic Artery Infusion of Oxaliplatin, Leucovorin, and 2400 mg/m² Fluorouracil Versus Hepatic Artery Infusion of Oxaliplatin, Leucovorin, and 1200 mg/m² Fluorouracil for Unresectable Hepatocellular Carcinoma: a Randomised Phase 3 Non-inferiority Trial
Sun Yat-sen University3 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物
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
Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.
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
- •Age range from 18-75 years;
- •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;
- •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
5-fu 2400
Active Comparator
干预措施: 2400 mg/m² 5-fu (Drug)
5-fu 1200
Experimental
干预措施: 1200 mg/m² 5-fu (Drug)
结局指标
主要结局
overall survival
时间窗: 24 months
次要结局
- Adverse Events(30 Days after HAIC)
- progression-free survival(24 months)
- objective response rate(6 months)
- disease control rate(6 months)
研究者
Shi Ming
Proffessor
Sun Yat-sen University
研究点 (3)
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