NCT03368651招募中3 期
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent 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 230 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent 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≤1;
- •proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- •not previous treated for tumor;
- •estimated tumor and tumor thrombosis could be removed en bloc in operation;
- •no distant metastasis;
- •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;
- •distant 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 hemorrhage or cardiac/brain vascular events within 30 days;
- •pregnancy;
研究组 & 干预措施
treatment group
Experimental
transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
干预措施: TAI (Procedure)
control group
No Intervention
no neo-adjuvant treatment before operation
结局指标
主要结局
Overall survival (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
- recurrence-free survival (RFS)(From date of randomization until the date of recurrence, assessed up to 60 months)
- recurrence rate(1 year, 2 year, 3 year, 5 year after surgery)
研究者
Rong-ping Guo
Professor
Sun Yat-sen University
研究点 (1)
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