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

Phase 3 Completed 150 enrolled National Cancer Institute, Milan Associazione Italiana per la Ricerca sul Cancro · collab

RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start: 1998-06
Primary completion: —
Completion: 2005-09

Outcome

Missed primary endpoint

paper no significant difference in RFS was detectable between the two study arms (24.3% vs. 5.8%; P = .49). PMID 17133492 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	interferon alfa-2b	Protein / enzyme biologic	3e+06 iu	—