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

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Thalidomide

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