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

Hepatocellular Carcinoma Clinical Trial

— LDT-RFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00728078
• Other study ID #: RFA005
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 31, 2008
• Last updated: February 6, 2009
• Start date: July 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2009
• Source: Sun Yat-sen University
• Contact: min-shan chen, MD
• Phone: 86-20-87343117
• Email: Chminsh[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• thalidomide
thalidomide 50mg tid for 6 months

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress free survival		1,3,5-year	No
Primary	morbility		one month	Yes
Secondary	overall survival		1,3,5-year	No
Secondary	recurrence rate		1,3,5-year	No