Status:
COMPLETED
Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Chang Gung Memorial Hospital
Tri-Service General Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
1. TREATMENT PLAN 1.1 Eligible patients are randomized to receive adjuvant IFN-α for 53 wks or 1.2 Administration of IFN-α 1.21 IFN-α will be started after randomization. 1.22 IFN-α will be admini...
Eligibility Criteria
Inclusion
- Histologically proven hepatocellular carcinoma.
- HCC underwent curative resection within 6 weeks before registration.
- Grossly, the resection margin should be \> 1 cm.
- Patients must be younger than 70 year-old.
- Patients must have a performance status of ECOG score \< 2.
- Patients must have adequate liver reservation and adequate hemogram.
- Pugh-Child's Score \< 7.
- The serum total bilirubin level are \< 2 mg/dl.
- The prothrombin times are \< 3 sec above normal control.
- The platelet are \> 10 x 104 / mm3.
- The WBC are \> 3,000 / mm3.
- Patient must have serum creatinine \< 1.5 mg/dl
- Cardiac function with NYHA classification \< Grade II
- Known HBV or HCV status.
- Signed informed consent.
Exclusion
- Patients who have non-curative resection are not eligible.
- Resected HCCs with histologically positive margins are not eligible.
- HCCs with radiological evidence of portal vein thrombus are not eligible.
- Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- Patients with advanced second primary malignancy are not eligible.
- Patients with pregnacy or breast-feeding are not eligible.
- Patients with severe cardiopulmonary diseases are not eligible.
- Patients with clinically significant psychiatric disorder are not eligible.
- Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00149565
Start Date
October 1 1997
End Date
July 1 2005
Last Update
December 16 2005
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333