Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (LDT-RFA)

Sun Yat-sen University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Hepatocellular Carcinoma

Liver Cancer

Treatments

Drug: thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00728078

RFA005

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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