Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

Phase 3 Completed 268 enrolled National Health Research Institutes, Taiwan Chang Gung Memorial Hospital · collab China Medical University Hospital · collab Mackay Memorial Hospital · collab National Taiwan University Hospital · collab Taipei Veterans General Hospital, Taiwan · collab Tri-Service General Hospital (TSGH) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

\* OBJECTIVES 1. To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years recurrence rate in curatively resected HCC . 2. To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in curatively resected HCC. 3. To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC with or without cirrhosis. 4. To investigate the change of activity of HBV and HCV in postoperative HCC patients with adjuvant IFN-α therapy. 5. To correlate the changes of viral status with the clinical outcome in post-operative HCC patients with adjuvant IFN-α therapy.

Timeline

Start: 1997-10
Primary completion: —
Completion: 2005-07

Outcome

Missed primary endpoint

paper In this study, adjuvant IFNα-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC. PMID 22104564 ↗

paper (P = 0.828, log-rank test). PMID 22104564 ↗

Publications

Chen LT, Chen MF, Li LA, Lee PH, Jeng LB, Lin DY, Wu CC, Mok KT, Chen CL, Lee WC, Chau GY, Chen YS, Lui WY, Hsiao CF, Whang-Peng J, Chen PJ; Disease Committee of Adjuvant Therapy for Postoperative Hepatocellular Carcinoma, Taiwan Cooperative Oncology Group, National Health Research Institutes, Zhunan, Taiwan. Long-term results of a randomized, observation-controlled, phase III trial of adjuvant interferon Alfa-2b in hepatocellular carcinoma after curative resection. Ann Surg. 2012 Jan;255(1):8-17. doi: 10.1097/SLA.0b013e3182363ff9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	interferon alfa-2b	Protein / enzyme biologic	5e+06 iu	Subcutaneous