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

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

progress free survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

min-shan chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University


China: Ministry of Health

Study ID:




Start Date:

July 2008

Completion Date:

July 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • hepatocellular carcinoma
  • liver cancer
  • radiofrequency ablation
  • thalidomide
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular