Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)

Detailed Description
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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

Official Title
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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

Conditions
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Quality of Life

Intervention / Treatment
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* Dietary Supplement: Oncoxin
* Drug: Suranix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oncoxin<br>Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days | Dietary Supplement: Oncoxin<br>* Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days<br>|
| Active Comparator: Oncoxin & Suranix<br>Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days | Dietary Supplement: Oncoxin<br>* Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days<br>Drug: Suranix<br>* Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days<br>* Other names: Suranib;|
| No Intervention: Supportive treatment<br>Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have prolonged survival | To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serum alpha-fetoprotein level and decrease in tumor size | To see whether Oncoxin plus Surafenib results in reduction in serum alpha-fetoprotein level in ng/ml and decrease in tumor size in mm in hepatocellular carcinoma patients off treatment for 24 weeks, after receiving Oncoxin plus Surafenib for 24 weeks. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncoxin, Hepatocellular carcinoma, Surafenib