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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma, Liver Cancer

Intervention / Treatment
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* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>low-dose thalidomide adjuvant therapy after RFA for HCC | Drug: thalidomide<br>* thalidomide 50mg tid for 6 months<br>|
| No Intervention: 2<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival |  | 1,3,5-year | 
| morbility |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1,3,5-year | 
| recurrence rate |  | 1,3,5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, liver cancer, radiofrequency ablation, thalidomide