NCT02580253撤回2 期
Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
Zhejiang University1 个研究点 分布在 1 个国家开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Desease free Survival
研究概览
简要总结
This study is a randomized, open-label, controlled study that will explore the efficacy of individualized adjuvant chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay for patients with hepatocellular carcinoma after liver transplantation.
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
- •Patients who had experienced liver transplantation with histologically confirmed advanced hepatocellular carcinoma with more one risk factor (tumour burden >8 cm, AFP>400 ng/mL,poorly differentiated,vessels invasion )
- •No extrahepatic metastasis confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
- •Additional inclusion criteria were age 18 years or older
- •Karnofsky performance status (KPS) of at least 70%
- •Adequate renal function, defined as creatinine clearance greater than 30 mL/min)
- •Adequate hepatic function, defined as ALT and AST less than 5× upper limit of normal
- •Adequate bone marrow function, defined as platelets greater than 100×10E9/L and WBC greater than 3.5×10E9/L.
排除标准
- •The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
- •Hypersensitivity to study drugs
- •Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
- •National Cancer Institute CommonToxicity Criteria (NCI-CTC) grade 3 or 4 sensory or motor neuropathy
- •Prior or concurrent malignancy (other than pancreatic cancer)
- •Female, pregnancy or breastfeeding.
研究组 & 干预措施
mFOLFOX6
Active Comparator
Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w
干预措施: mFOLFOX6 (Drug)
Individualized Chemotherapy
Experimental
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
干预措施: Individualized Chemotherapy (Drug)
结局指标
主要结局
Desease free Survival
时间窗: 3 years
次要结局
- Overall Survival(3 years)
研究者
Weijia Fang, MD
Director
Zhejiang University
研究点 (1)
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