A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Resectability
研究概览
简要总结
The purpose of this study is to evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment
- •Diagnosis of HCC confirmed by histology
- •Child-Pugh class A cirrhosis with adequate remnant liver parenchyma
- •Measurable disease
- •Fit enough to undergo surgery to resect the primary liver tumour
排除标准
- •Prior systemic therapy for HCC
- •Presence of extrahepatic metastasis
- •History of liver transplantation
- •Peripheral sensory neuropathy with functional impairment
- •Uncontrolled hypertension/ cardiac disease
研究组 & 干预措施
SECOX
Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1
干预措施: Sorafenib (Drug)
SECOX
Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1
干预措施: Capecitabine (Drug)
SECOX
Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Resectability
时间窗: At the end of Cycle 4 (each cycle is 14 days)
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
次要结局
- Progression-free survival(Approximately 18 months)
- Overall survival(Approximately 33 months)
- Objective response rate(At the end of Cycle 4 (each cycle is 14 days))
研究者
Dr. YAU Chung Cheung Thomas
Clinical Associate Professor
The University of Hong Kong