Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour <5cm, or up to 3 tumours, each <3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none >4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of >70% and recurrence rate ranging from 5-15% can be achieved.
Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria，and qualify for LT.
This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 listed for liver transplant;
- •Child-Pugh Stage A or B
- •Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- •Not previous treated for tumor;
- •The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT
- •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 LT;
- •Distant metastasis exits;
- •Known history of other malignancy;
- •Be allergic to related drugs;
- •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;
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
From date of randomization until the date of death from any cause, assessed up to 60 months
次要结局
- PFS(From date of randomization until the date of progression, assessed up to 60 months)
- recurrence rate(1 year, 2 year, 3 year, 5 year after surgery)
- RFS(From date of randomization until the date of recurrence, assessed up to 60 months)
研究者
Beicheng Sun
Director, Hepatobiliary Surgery
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School