NCT02716766已完成2 期
Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic hepatocellular carcinoma (HCC) not suitable for surgery or various loco-regional therapies.
- •Diagnosis of HCC confirmed either by cyto-histological confirmation or by non-invasive criteria according to the European Association for Study of Liver disease (EASL) criteria.
- •Child-Pugh A or B7 cirrhosis.
- •Eastern Co-Operative Group (ECOG) performance status ≤
- •Life expectancy of ≥ 12 weeks.
- •Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
- •Measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (CT) or magnetic resonance imaging (MRI).
- •Able and willing to meet all protocol-required treatments, investigations and visits.
- •Signed written informed consent form.
排除标准
- •Prior systemic therapy for advanced HCC.
- •Central nervous system (CNS) metastasis.
- •History of liver transplantation.
- •Peripheral sensory neuropathy with functional impairment before the first cycle of treatment.
- •History of cardiac disease.
- •Uncontrolled hypertension.
- •Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
研究组 & 干预措施
SECOX
Experimental
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
Experimental
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
Experimental
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)
Sorafenib
Active Comparator
Sorafenib 400 mg twice daily from Day 1 to 14
干预措施: Sorafenib (Drug)
结局指标
主要结局
Time to progression (TTP)
时间窗: Approximately 18 months
Time from study treatment to radiological progression
次要结局
- Objective Response Rate (ORR)(Approximately 18 months)
- Progression-free survival (PFS)(Approximately 18 months)
- Overall survival (OS)(Approximately 33 months)
- Frequency and severity of adverse events and laboratory abnormalities(Approximately 18 months)
研究者
研究点 (1)
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