Clinical trial · Interventional
Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis
Adjuvant α-Interferon Treatment After Resection of Hepatocellular Carcinoma in HCV-Related Cirrhosis: a Randomized Trial on Prevention of Cancer Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Resection | — | UNRESOLVED | — |
| Hepatitis C Virus Infection | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Interferon Treatment | — | UNRESOLVED | — |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon alpha-2b | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recurrence Free Survival
Secondary outcomes (2)
- measure
- Disease Specific Survival
- measure
- Overall Patient Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMazzaferro 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