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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00728078

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Liver Cancer	Drug: thalidomide	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2009

Anticipated Study Completion Date :

Jul 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

low-dose thalidomide adjuvant therapy after RFA for HCC

Drug: thalidomide

thalidomide 50mg tid for 6 months

No Intervention: 2

control group

Outcome Measures

Primary Outcome Measures

progress free survival [1,3,5-year]
morbility [one month]

Secondary Outcome Measures

overall survival [1,3,5-year]
recurrence rate [1,3,5-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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