Study to Evaluate Safety and Therapeutic Efficacy of a Combination Therapy of 'Oncoxin', a Nutritional Supplement and Surafenib, a Multikinase Inhibitor in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients who have prolonged survival
研究概览
简要总结
Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)
详细描述
To assess therapeutic efficacy and safety of Oncoxin plus Surafenib in hepatocellular carcinoma
To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
To see if there is improved survival in hepatocellular carcinoma patients after administration of Oncoxin plus Surafenib
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCC irrespective of etiology, age, gender and status of underlying liver disease.
- •Patients with HCC who are not suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- •Patients with HCC who have evidence of tumor metastasis
- •Patients with HCC who are voluntarily unwilling to take established modalities of treatment i.e. surgery and/or chemotherapy.
- •Patients with HCC in whom all possible treatment options have been exhausted.
排除标准
- •Patients with HCC who are suitable candidates for established modalities of treatment i.e. surgery and/or chemotherapy.
- •Patients with HCC who have no evidence of tumor metastasis
- •Patients with HCC who are willing to take established modalities of treatment i.e. surgery and/or chemotherapy.
- •Patients with HCC who are voluntarily unwilling to be included in the trial
研究组 & 干预措施
Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
干预措施: Oncoxin (Dietary Supplement)
Oncoxin & Suranix
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
干预措施: Oncoxin (Dietary Supplement)
Oncoxin & Suranix
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
干预措施: Suranix (Drug)
结局指标
主要结局
Number of patients who have prolonged survival
时间窗: 24 weeks
To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks
次要结局
- Reduction in serum alpha-fetoprotein level and decrease in tumor size(24 weeks)