Safety and Efficacy of Oncoxin Plus Surafineb in Hepatocellular Carcinoma

December 11, 2012 updated by: Clinical Research Organization, Dhaka, Bangladesh

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1215
        • Recruiting
        • Farabi General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mamun A Mahtab, MD, FACG
        • Sub-Investigator:
          • Lovely Begum, BPharm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
Dietary supplement: Oncoxin
Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
ACTIVE_COMPARATOR: Oncoxin & Suranix
Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd orally for 180 days
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
Other Names:
  • Nexavar
  • Suranib
NO_INTERVENTION: Supportive treatment
Only supportive treatment. No chemotherapy, radoiotherapy, ablation or surgical intervention will be carried out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who have prolonged survival
Time Frame: 24 weeks
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
Time Frame: 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Organization, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Mamun A Mahtab, MD, FACG, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (ESTIMATE)

December 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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