Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747642
• Other study ID #: OP2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 7, 2012
• Last updated: December 11, 2012
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2012
• Source: Clinical Research Organization, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Directorate of Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Quality of Life

Intervention

Dietary Supplement:
• Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days

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

Locations

Country	Name	City	State
Bangladesh	Farabi General Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Organization, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   Dr. Mamun A. Mahtab is the PI of this study