NCT02259647已完成不适用
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma - a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and control group will receive Sorafenib plus placebo
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Child A and B cirrhosis with hepatocellular carcinoma
- •Biochemical, Radiological, histological evidence of advanced hepatocellular carcinoma diagnosed as stage C and stage d with serum bilirubin <5 mg/dl according to BCLC staging system
- •HCC with portal vein thrombosis
- •Unresectable cancer, as assessed carefully by individual experts
- •No recent active treatment like surgery, radiofrequency ablation, trans arterial chemo embolization, radiotherapy, chemotherapy (within the past 6 months)
排除标准
- •Patients with end-stage hepatocellular carcinoma (Stage D, BCLC)with poor performance status
- •Child C cirrhosis with HCC (Hepatocellular carcinoma)
- •HCC with acute decompensated state of CLD - GI bleed, increased jaundice, HE, SBP (Spontaneous Bacterial Peritonitis)
- •Acute febrile illness
- •Pregnancy or lactation
研究组 & 干预措施
Sorafenib +intravenous infusion ofVit K1
Experimental
Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month
干预措施: Sorafenib 400mg twice daily + intravenous infusion ofVit K1 (Drug)
Sorafenib+Placebo
Active Comparator
Sorafenib 400 mg twice daily + Intravenousinfusion of placebo daily for 6 days, followed by oral placebo twice daily till 3month
干预措施: Sorafenib 400 mg twice daily + Intravenousinfusion of placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 Year
次要结局
- Disease control rate (DCR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria(3 months)
- Biochemical response - improvement in tumor biomarker level(3 months)
- Safety(1 Years)
- Objective response rate (ORR) of tumour based on mRECIST (Response Evaluation Criteria In Solid Tumors ) criteria(3 months)
研究者
研究点 (1)
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