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Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01747642
Enrollment
60
Registered
2012-12-12
Start date
2012-12-31
Completion date
2014-06-30
Last updated
2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Hepatocellular carcinoma, Oncoxin, Surafenib

Brief summary

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

Detailed description

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

Interventions

DRUGSuranix

Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days

DIETARY_SUPPLEMENTOncoxin

Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days

Sponsors

Clinical Research Organization, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who have prolonged survival24 weeksTo study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks

Secondary

MeasureTime frameDescription
Reduction in serum alpha-fetoprotein level and decrease in tumor size24 weeksTo 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.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026