NCT03777475Unknown不适用
the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.
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
- •older than 18 years old and younger than 75 years;
- •ECOG PS≤1;
- •proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- •not previous treated for tumor;
- •unresectable;
- •the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
- •sign up consent
排除标准
- •cannot tolerate TAI or surgery;
- •known history of other malignancy;
- •be allergic to related drugs;
- •underwent organ transplantation before;
- •be treated before (interferon included);
- •known history of HIV infection;
- •known history of drug or alcohol abuse;
- •have GI hemorrhage or cardiac/brain vascular events within 30 days;
- •pregnancy
研究组 & 干预措施
low dose
Experimental
low oxaliplatin (85mg/m2)
干预措施: transarterial infusion (Procedure)
high dose
Active Comparator
high oxaliplatin (135mg/m2)
干预措施: transarterial infusion (Procedure)
结局指标
主要结局
OS
时间窗: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
次要结局
- PFS(From date of randomization until the date of progress from any cause, assessed up to 60 months)
- ORR(From date of randomization until the date of death from any cause, assessed up to 60 months)
研究者
Rong-ping Guo
Professor
Sun Yat-sen University
研究点 (1)
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