Clinical trial NCT00728078: Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Official title: Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Liver Cancer
Keywords: hepatocellular carcinoma
liver cancer
radiofrequency ablation
thalidomide
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-08-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: progress free survival
timeFrame: 1,3,5-year
measure: morbility
timeFrame: one month
Secondary outcomes:
measure: overall survival
timeFrame: 1,3,5-year
measure: recurrence rate
timeFrame: 1,3,5-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
name: min-shan chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
citation: Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.