Hepatocellular Carcinoma Clinical Trial
Official title:
Randomized Clinical Study of Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide with an estimated
626,000 new cases per year worldwide, accounting for 5.7% of new cancer cases. Although
resection and transplantation offer the best 5-year survival rates, not all patients are
suitable surgery candidates. Other treatments include pericutaneous ethanol injection (PEI),
radiofrequency ablation (RFA), and transarterial oily chemoembolization (TOCE), all of which
enhance the survival rate and aid in shrinkage of the tumor. The very low survival rate
among HCC patients, 3-5%, reflects the inadequacy of conventional therapies for the disease
and highlights the necessity of finding new treatments or modifying the current treatment.
The hepatitis B virus (HBV) causes liver disease that can range in severity from a mild
illness that lasts several weeks (acute hepatitis B) to a long-term chronic illness. An
estimated 2 billion people have been infected with HBV worldwide, resulting in more than 350
million individuals with chronic, long-term liver infections. Patients with chronic HBV
infection are at a great risk for the development of cirrhosis, hepatic failure, and HCC.
There is no cure for hepatitis B and care is mostly palliative. There are several anti-viral
and interferon drugs, such as Entecavir and Interferon α therapy, which can help some
patients. However, these drugs are costly, thousands of dollars per year, and are not widely
available in many countries, especially in the developing world. Vaccination is available
and effective and is recommended for all individuals at risk for HBV infection. However,
vaccination is only effective in individuals who have not been exposed to HBV. Hepatitis B
is closely linked to liver cancer, which is almost always fatal.
MGN-3/Biobran is an arabinoxylan extracted from rice bran that is treated enzymatically with
an extract from Shiitake mushrooms. MGN-3 demonstrated anti-cancer activity in vivo in mice
and humans. The present study was carried out to examine whether combining the current
conventional treatment with a food supplement, arabinoxylan rice bran (MGN-3/Biobran), may
improve the outcome of the disease and increase the survival rate of patients with HCC or
HBV. We hypothesize that a combinatory treatment of conventional therapy with MGN-3/Biobran
will augment the therapeutic effect seen when patients are treated with conventional therapy
alone.
Status | Completed |
Enrollment | 130 |
Est. completion date | November 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion criteria: HCC patient Criteria of inclusion - Patient had =3 tumors (1 tumor under 12cm/ or 2 tumor under 5cm /or 3 tumor under 3cm) - Stage of disease: Okuda I,II and Child Pugh A,B - Liver biopsy: HCC positive - General condition: average/ good Chronic hepatitis B patient Criteria of inclusion - Patient have been carrying HBsAg over 6 months - ALT was over or equal 2 times ULN - HBV-DNA level: 104 (log10 copies/ml) with HBeAg(-) patient and 105 (log10 copies/ml) with HBeAg(+) patient Exclusion criteria: HCC patient Criteria of exclusion - Tumor size is too big (over 12 cm), multiple tumors (over 3 tumors or diffuse tumor type) - Prothrombin under 60% - Severe liver or/ and renal insufficiency - Portal vein body thrombosis Chronic hepatitis B patient Criteria of exclusion - Used immunotherapy or corticotherapy for 6 months - Pregnant woman |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | The 108 Military Central Hospital | Hanoi |
Lead Sponsor | Collaborator |
---|---|
The 108 Military Central Hospital | Charles Drew University of Medicine and Science |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient survival | 3 years | No | |
Secondary | Disease recurrence | 3 years | No |
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