Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

NCT00149565 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2005-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IFN-α2b

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER
  • Tri-Service General Hospital

    collaborator OTHER
  • National Taiwan University Hospital

    collaborator OTHER
  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV
  • Mackay Memorial Hospital

    collaborator OTHER
  • China Medical University Hospital

    collaborator OTHER
  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, Ph.D. · Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG

  • Pei-Jer Chen, Ph.D. · Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-10-31
Completion
2005-07-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00149565 on ClinicalTrials.gov