Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

NCT ID: NCT00728078

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).

Detailed Description

Our previous studies showed that radiofrequency ablation (RFA) was as effective as liver resection for small hepatocellular carcinoma (HCC), but the recurrence rates after RFA were relatively high. Adjuvant therapies maybe reduce the recurrence rate. Phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for HCC, especially for small HCC with liver cirrhosis. So we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after RFA for HCC.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

low-dose thalidomide adjuvant therapy after RFA for HCC

Group Type: EXPERIMENTAL

thalidomide

Intervention Type: DRUG

thalidomide 50mg tid for 6 months

2

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

thalidomide

thalidomide 50mg tid for 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 - 75 years, who refused surgery or first recurrence after hepatectomy
• A solitary HCC 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm
• Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
• No extrahepatic metastasis
• No imaging evidence of invasion into the major portal/hepatic vein branches
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
• A platelet count of > 40,000/mm3
• No previous treatment of HCC except liver resection

Exclusion Criteria

• Patient compliance is poor
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
• History of cardiac disease:

• congestive heart failure > New York Heart Association (NYHA) class 2
• active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
• cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, *calcium channel blocker or digoxin
• uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs)
• Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Distantly extrahepatic metastasis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

cancer canter, Sun Yat-sen University

Principal Investigators

min-shan chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Locations

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

min-shan chen, MD

Role: CONTACT

Chminsh@mail.sysu.edu.cn

86-20-87343117 ext. 86-20-87343117

Facility Contacts

min-shan chen, MD

Role: primary

Chminsh@mail.sysu.edu.cn

86-20-87343117 ext. 86-20-87343117

References

Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

Reference Type: RESULT

PMID: 16495695 (View on PubMed)

Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.

Reference Type: RESULT

PMID: 11419162 (View on PubMed)

Other Identifiers

RFA005

Identifier Type: -

Identifier Source: org_study_id