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Oncoxin in combination with Surafenib is safe and results in improved survival in patients with hepatocellular carcinoma (HCC)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncoxin | Active Comparator | Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days |
|
| Oncoxin & Suranix | Active Comparator | Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days |
|
| Supportive treatment | No Intervention | Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncoxin | Dietary Supplement | Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mamun A Mahtab, MD, FACG | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farabi General Hospital | Recruiting | Dhaka | 1215 | Bangladesh |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Suranix | Drug | Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days |
|
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |