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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00234182
First received: October 5, 2005
Last updated: November 29, 2005
Last verified: October 2005
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Interferon alpha-2b
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Adjuvant Therapy With Recombinant Interferon-Alpha Following Curative Resection of Hepatocellular Carcinoma: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Occurrence of recurrent disease

Secondary Outcome Measures:
  • Death of the patient

Estimated Enrollment: 84
Study Start Date: January 2000
Estimated Study Completion Date: December 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:

  1. presence of hepatic encephalopathy
  2. presence of ascites not controlled by diuretics
  3. history of variceal bleeding within last 3 months
  4. total serum bilirubin > 50 umol/L
  5. serum albumin < 30 g/L
  6. 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00234182

Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Chung Mau Lo, MS Department of Surgery, The University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234182     History of Changes
Other Study ID Numbers: EC 1018-98
Study First Received: October 5, 2005
Last Updated: November 29, 2005
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
liver cancer
hepatectomy
survival
recurrence

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014