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

Phase 2

• Conditions: Hepatocellular Carcinoma; Liver Cancer
• Interventions: Drug: thalidomide

• Registration Number: NCT00728078
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09
• Primary Completion: 2009-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	thalidomide	low-dose thalidomide adjuvant therapy after RFA for HCC

Primary Outcome Measures

Name	Time	Method
progress free survival	1,3,5-year
morbility	one month

Secondary Outcome Measures

Name	Time	Method
overall survival	1,3,5-year
recurrence rate	1,3,5-year

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China