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Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

Primary Purpose

Quality of Life

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Oncoxin
Suranix
Sponsored by
Clinical Research Organization, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Hepatocellular carcinoma, Oncoxin, Surafenib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Farabi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Oncoxin

Oncoxin & Suranix

Supportive treatment

Arm Description

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

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

Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2012
Last Updated
December 11, 2012
Sponsor
Clinical Research Organization, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01747642
Brief Title
Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Organization, Dhaka, Bangladesh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
Hepatocellular carcinoma, Oncoxin, Surafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncoxin
Arm Type
Active Comparator
Arm Description
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
Arm Title
Oncoxin & Suranix
Arm Type
Active Comparator
Arm Description
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
Arm Title
Supportive treatment
Arm Type
No Intervention
Arm Description
Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin
Intervention Description
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
Intervention Type
Drug
Intervention Name(s)
Suranix
Other Intervention Name(s)
Nexavar, Suranib
Intervention Description
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
Primary Outcome Measure Information:
Title
Number of patients who have prolonged survival
Description
To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Reduction in serum alpha-fetoprotein level and decrease in tumor size
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamun A Mahtab, MD, FACG
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farabi General Hospital
City
Dhaka
ZIP/Postal Code
1215
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamun A Mahtab, MD, FACG
Phone
+8801711567275
Email
shwapnil@agni.com
First Name & Middle Initial & Last Name & Degree
Helal Uddin, BSc
Phone
+880-1819251514
Email
crobangladesh@gmail.com
First Name & Middle Initial & Last Name & Degree
Mamun A Mahtab, MD, FACG
First Name & Middle Initial & Last Name & Degree
Lovely Begum, BPharm

12. IPD Sharing Statement

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Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

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