Hepatocellular Carcinoma Clinical Trial
Official title:
Adjuvant α-Interferon Treatment After Resection of Hepatocellular Carcinoma in HCV-Related Cirrhosis: a Randomized Trial on Prevention of Cancer Recurrence
Verified date | September 2005 |
Source | National Cancer Institute, Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of HCC(control group)
Status | Completed |
Enrollment | 150 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - HCV-RNA positive / HBsAg-negative patients with HCC undergoing potentially curative resection - Curative surgery (i.e. no residual tumor intraoperative US and tumor-free margins at pathology) - No recurrence 1 month after surgery (CT, NMR, US) - Pre-resection treatments allowed (TACE, RFA, PEI) - HCV-RNA positive (lower limit of detection: 100 copies/ml) regardless of blood titers or genotype Exclusion Criteria: - HBsAg-positivity - Evidence of any active neoplastic site - Previous IFN or chemotherapy or treatment of other tumors - Severe surgical complication and/or causes of cirrhosis not related to HCV - Patient comorbidity (Hb <12 g/dl, HIV infection, autoimmune disease, psychiatric disorder, seizure, severe cardiovascular disease, poorly controlled diabetes, BMI >35) - Active alcohol intake (>80 g/day) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | National Cancer Institute | Milan |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Milan | Associazione Italiana per la Ricerca sul Cancro |
Italy,
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Primary | Recurrence Free Survival | |||
Secondary | Disease Specific Survival | |||
Secondary | Overall Patient Survival |
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