Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Milan
• Collaborator: Associazione Italiana per la Ricerca sul Cancro
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

Criteria

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)