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

NCT00273247 | Completed Phase 3

• 1 other identifier: INT-98-016
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Hepatocellular Carcinoma; Hepatitis C Virus Infection; Liver Cirrhosis; Interferon Treatment; Hepatic Resection

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

Secondary Outcomes (2)

• Disease Specific Survival

• Overall Patient Survival

Interventions

Interferon alpha-2b DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Milan: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator

Study Sites (1)

National Cancer Institute

Milan, 20133, Italy

Location

Related Publications (1)

• Mazzaferro V, Romito R, Schiavo M, Mariani L, Camerini T, Bhoori S, Capussotti L, Calise F, Pellicci R, Belli G, Tagger A, Colombo M, Bonino F, Majno P, Llovet JM; HCC Italian Task Force. Prevention of hepatocellular carcinoma recurrence with alpha-interferon after liver resection in HCV cirrhosis. Hepatology. 2006 Dec;44(6):1543-54. doi: 10.1002/hep.21415.

  PMID: 17133492 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C; Liver Cirrhosis

Interventions

Introns

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Vincenzo Mazzaferro, MD

  National Cancer Institute, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: June 1, 1998
• Study Completion: September 1, 2005
• Last Updated: January 9, 2006

Record last verified: 2005-09

Locations

IT (1)