Postoperative Adjuvant Therapy With Recombinant Interferon-Alpha Following Curative Resection of HCC

NCT00234182 | Completed Phase 1

• 1 other identifier: EC 1018-98
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

We conducted a randomized controlled trial of adjuvant interferon therapy in patients with predominantly hepatitis B-related hepatocellular carcinoma (HCC) to investigate whether the prognosis after hepatic resection could be improved. Since February 1999, patients with no residual disease after hepatic resection for HCC were randomly assigned with stratification by pTNM stage to receive no treatment (control group), interferon alpha-2b 10 MIU/m2 (IFN-I group) or 30 MIU/m2 (IFN-II group) thrice weekly for 16 weeks. Enrollment to the IFN-II group was terminated from January 2000 because adverse effects resulted in treatment discontinuation in the first 6 patients. By June 2002, 40 patients each had been enrolled into the control group and IFN-I group. The baseline clinical, laboratory and tumor characteristics of both groups were comparable. The 1- and 5-year survival rates were 85% and 61%, respectively for the control group and 97% and 79%, respectively for the IFN-I group (P=0.137). After adjusting for the confounding prognostic factors in a Cox model, the relative risk of death for interferon treatment was 0.42 (95% CI 0.17 - 1.05; P=0.063). Exploratory subset analysis showed that adjuvant interferon had no survival benefit for pTNM stage I/II tumor (5-year survival 90% in both groups; P=0.917) but prevented early recurrence and improved the 5-year survival of patients with stage III/IVA tumor from 24% to 68% (P=0.038). In conclusion, in a group of patients with predominantly hepatitis B-related HCC, adjuvant interferon therapy prevented early recurrence and improved survival in those with pTNM stage III/IVA tumors.

Conditions

Hepatocellular Carcinoma

Keywords

liver cancer; hepatectomy; survival; recurrence

Outcome Measures

Primary Outcomes (1)

• Occurrence of recurrent disease

Secondary Outcomes (1)

• Death of the patient

Interventions

Interferon alpha-2b DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who undergo a curvative hepatic resection for HCC at the Department of Surgery, Queen Mary Hospital are included. The criteria for curative resection include all of the following :
• i) Complete extirpation of disease as demonstrated by intraoperative ultrasonography during surgery ii) Histologic evidence of a clear resection margin iii) No evidence of residual disease in the liver remnant as demonstrated by spiral contrast-enhanced CT scan one month after surgery

You may not qualify if:

• i) patient refusal ii) age \> 75 years old iii) hospital mortality iv) disease previously treated by regional or systemic chemotherapy, hormonal therapy or immunotherapy v) poor hepatic function:
• presence of hepatic encephalopathy
• presence of ascites not controlled by diuretics
• history of variceal bleeding within last 3 months
• total serum bilirubin \> 50 umol/L
• serum albumin \< 30 g/L
• prothrombin time prolonged for \> 4 seconds vi) poor renal function with serum creatinine \> 180mol/L vii) Absolute neutrophil count \< 1.5 x 109/L viii) Platelet count \< 75 x 109/L ix) poor performance status with European Cooperative Oncology Group (ECOG) scale grade III or IV

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Recurrence

Interventions

Introns

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chung Mau Lo, MS

  Department of Surgery, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 6, 2005
• Study Start: January 1, 2000
• Study Completion: December 1, 2004
• Last Updated: December 1, 2005

Record last verified: 2005-10