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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


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Quality of Life

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients who have prolonged survival

Outcome Description:

To study the number of participants who have prolonged survival in months after receiving Oncoxin plus Surafenib for 24 weeks

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Mamun A Mahtab, MD, FACG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Authority:

Bangladesh: Directorate of Drug Administration

Study ID:

OP2

NCT ID:

NCT01747642

Start Date:

December 2012

Completion Date:

June 2014

Related Keywords:

  • Quality of Life
  • Hepatocellular carcinoma
  • Oncoxin
  • Surafenib
  • Carcinoma
  • Carcinoma, Hepatocellular

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