Status:
COMPLETED
Postoperative Adjuvant Therapy With Recombinant Interferon-Alpha Following Curative Resection of HCC
Lead Sponsor:
The University of Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 h...
Detailed Description
1. Background Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death in Hong Kong and the majority are hepatitis B related. Hepatic resection has remained the only therapeuti...
Eligibility Criteria
Inclusion
- 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
- 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 \> 180mol/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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00234182
Start Date
January 1 2000
End Date
December 1 2004
Last Update
December 1 2005
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