NCT03192618招募中3 期
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2017年7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
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.
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<3;
- •proven hepatocellular carcinoma with MVI according pathological examination;
- •not previous treated for tumor;
- •tumor was removed in operation;
- •no recurrence occurence at 4 to 7 weeks after surgery;
- •the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
- •sign up consent;
- •unrolled by other clinical trials about hepatocellular carcinoma.
排除标准
- •cannot tolerate TAI;
- •CNS or bone metastasis exits;
- •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 hemorreage or cardiac/brain vascular events within 30 days;
- •pregnancy;
研究组 & 干预措施
treatment group
Experimental
干预措施: adjuvant transarterial chemoinfusion (TAI) (Procedure)
treatment group
Experimental
干预措施: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: From date of randomization until the date of recurrence, assessed up to 60 months
disease-free survival
次要结局
- recurrence rate(1 year, 2 year, 3 year, 5 year after surgery)
- Overall survival (OS)(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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