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

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

thalidomide

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, liver cancer, radiofrequency ablation, thalidomide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Cancer Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

low-dose thalidomide adjuvant therapy after RFA for HCC

control group

Outcomes

Primary Outcome Measures

progress free survival

morbility

Secondary Outcome Measures

overall survival

recurrence rate

Full Information

NCT ID

NCT00728078

First Posted

July 31, 2008

Last Updated

February 6, 2009

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00728078

Brief Title

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

Acronym

LDT-RFA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

July 2009 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Liver Cancer

Keywords

hepatocellular carcinoma, liver cancer, radiofrequency ablation, thalidomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

low-dose thalidomide adjuvant therapy after RFA for HCC

Arm Title

Arm Type

No Intervention

Arm Description

control group

Intervention Type

Drug

Intervention Name(s)

thalidomide

Intervention Description

thalidomide 50mg tid for 6 months

Primary Outcome Measure Information:

Title

progress free survival

Time Frame

1,3,5-year

Title

morbility

Time Frame

one month

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

1,3,5-year

Title

recurrence rate

Time Frame

1,3,5-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

min-shan chen, MD

Phone

86-20-87343117

Ext

86-20-87343117

Chminsh@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

min-shan chen, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

min-shan chen, MD

Phone

86-20-87343117

Ext

86-20-87343117

Chminsh@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

min-shan chen, MD

First Name & Middle Initial & Last Name & Degree

yao-jun zhang, Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

16495695

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.

Results Reference

result

PubMed Identifier

11419162

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.

Results Reference

result

Learn more about this trial

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

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