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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00728078
First received: July 31, 2008
Last updated: February 6, 2009
Last verified: February 2009

July 31, 2008
February 6, 2009
July 2008
July 2009   (final data collection date for primary outcome measure)
  • progress free survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
  • morbility [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00728078 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
  • recurrence rate [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma
  • Liver Cancer
Drug: thalidomide
thalidomide 50mg tid for 6 months
  • Experimental: 1
    low-dose thalidomide adjuvant therapy after RFA for HCC
    Intervention: Drug: thalidomide
  • No Intervention: 2
    control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
July 2011
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn
China
 
NCT00728078
RFA005
Yes
cancer canter, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: min-shan chen, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Sun Yat-sen University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP