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

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).

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Liver Cancer
• Intervention / Treatment: Drug: thalidomide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Cancer Center, Sun Yat-sen University
      • Contact: min-shan chen, MD; Phone Number: 86-20-87343117 86-20-87343117; Email: Chminsh@mail.sysu.edu.cn
      • Principal Investigator: min-shan chen, MD
      • Sub-Investigator: yao-jun zhang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; control group
Experimental: 1; low-dose thalidomide adjuvant therapy after RFA for HCC	Drug: thalidomide; thalidomide 50mg tid for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progress free survival	1,3,5-year
morbility	one month

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	1,3,5-year
recurrence rate	1,3,5-year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: min-shan chen, MD, Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: July 31, 2008
• First Posted (Estimate): August 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: radiofrequency ablation; hepatocellular carcinoma; liver cancer; thalidomide
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: RFA005