Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

NCT00149565 | Completed Phase 3

• 1 other identifier: T1297
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

\* OBJECTIVES

1. 1.To investigate whether adjuvant IFN-α therapy can delay or reduce the 2-5 years recurrence rate in curatively resected HCC .
2. 2.To examine whether adjuvant IFN-α therapy can prolong the disease-free survival in curatively resected HCC.
3. 3.To determine the safety and tolerance of adjuvant IFN-α therapy in postoperative HCC with or without cirrhosis.
4. 4.To investigate the change of activity of HBV and HCV in postoperative HCC patients with adjuvant IFN-α therapy.
5. 5.To correlate the changes of viral status with the clinical outcome in post-operative HCC patients with adjuvant IFN-α therapy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 134 patients for each of the two treatment arms are needed.

Interventions

IFN-α2b DRUG

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Chang Gung Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator
• National Taiwan University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Mackay Memorial Hospital: collaborator
• China Medical University Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Chen LT, Chen MF, Li LA, Lee PH, Jeng LB, Lin DY, Wu CC, Mok KT, Chen CL, Lee WC, Chau GY, Chen YS, Lui WY, Hsiao CF, Whang-Peng J, Chen PJ; Disease Committee of Adjuvant Therapy for Postoperative Hepatocellular Carcinoma, Taiwan Cooperative Oncology Group, National Health Research Institutes, Zhunan, Taiwan. Long-term results of a randomized, observation-controlled, phase III trial of adjuvant interferon Alfa-2b in hepatocellular carcinoma after curative resection. Ann Surg. 2012 Jan;255(1):8-17. doi: 10.1097/SLA.0b013e3182363ff9.

  PMID: 22104564 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Li-Tzong Chen, Ph.D.

  Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG

  STUDY CHAIR

• Pei-Jer Chen, Ph.D.

  Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of TCOG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: October 1, 1997
• Study Completion: July 1, 2005
• Last Updated: December 16, 2005

Record last verified: 2004-12

Locations

TW (1)