Status:
COMPLETED
Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis
Lead Sponsor:
National Cancer Institute, Milan
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Conditions:
Hepatocellular Carcinoma
Hepatitis C Virus Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Detailed Description
Background Primary liver cancer (hepatocellular carcinoma, HCC) remains a major cancer-related cause of death with an estimated incidence of 1 million cases per year worldwide and particular endemic ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00273247
Start Date
June 1 1998
End Date
September 1 2005
Last Update
January 9 2006
Active Locations (1)
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1
National Cancer Institute
Milan, Italy, 20133