Phase Ⅲ Randomized Trial in Postoperative Hepatocellular Carcinoma

This study has been completed.

Sponsors and Collaborators:	National Health Research Institutes, Taiwan Chang Gung Memorial Hospital Tri-Service General Hospital National Taiwan University Hospital Taipei Veterans General Hospital,Taiwan Mackay Memorial Hospital China Medical University Hospital
Information provided by:	National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:	NCT00149565

Purpose

* OBJECTIVES

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

Condition	Intervention	Phase
Hepatocellular Carcinoma	Drug: IFN-α2b	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	Hepatocellular Carcinoma Postoperative Adjuvant Therapy Disease Committee of Taiwan Cooperative Oncology Group

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:

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

Estimated Enrollment:	268
Study Start Date:	October 1997
Estimated Study Completion Date:	July 2005

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Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:
1. Histologically proven hepatocellular carcinoma.
2. HCC underwent curative resection within 6 weeks before registration.
3. Grossly, the resection margin should be > 1 cm.
4. Patients must be younger than 70 year-old.
5. Patients must have a performance status of ECOG score < 2.
6. Patients must have adequate liver reservation and adequate hemogram.
7. Pugh-Child‘s Score < 7.
8. The serum total bilirubin level are < 2 mg/dl.
9. The prothrombin times are < 3 sec above normal control.
10. The platelet are > 10 x 104 / mm3.
11. The WBC are > 3,000 / mm3.
12. Patient must have serum creatinine < 1.5 mg/dl
13. Cardiac function with NYHA classification < Grade II
14. Known HBV or HCV status.
15. Signed informed consent.
Exclusion Criteria:
1. Patients who have non-curative resection are not eligible.
2. Resected HCCs with histologically positive margins are not eligible.
3. HCCs with radiological evidence of portal vein thrombus are not eligible.
4. Patients with other systemic diseases which required concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
5. Patients with advanced second primary malignancy are not eligible.
6. Patients with pregnacy or breast-feeding are not eligible.
7. Patients with severe cardiopulmonary diseases are not eligible.
8. Patients with clinically significant psychiatric disorder are not eligible.
9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149565

Locations

Taiwan
Chang Gung Memorial Hospital
Tao-Yuan, Taiwan, 333

Sponsors and Collaborators

National Health Research Institutes, Taiwan

Chang Gung Memorial Hospital

Tri-Service General Hospital

National Taiwan University Hospital

Taipei Veterans General Hospital,Taiwan

Mackay Memorial Hospital

China Medical University Hospital

Investigators

Study Chair:	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

More Information

Study ID Numbers:	T1297
Study First Received:	September 7, 2005
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00149565
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009