NCT00728078

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2008

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

July 31, 2008

Last Update Submit

February 6, 2009

Conditions

Hepatocellular CarcinomaLiver Cancer

Keywords

hepatocellular carcinomaliver cancerradiofrequency ablationthalidomide

Outcome Measures

Primary Outcomes (2)

  • progress free survival

    1,3,5-year

  • morbility

    one month

Secondary Outcomes (2)

  • overall survival

    1,3,5-year

  • recurrence rate

    1,3,5-year

Study Arms (2)

1

EXPERIMENTAL

low-dose thalidomide adjuvant therapy after RFA for HCC

Drug: thalidomide

2

NO INTERVENTION

control group

Interventions

thalidomideDRUG

thalidomide 50mg tid for 6 months

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16495695RESULT

  • 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.

    PMID: 11419162RESULT

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • min-shan chen, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

min-shan chen, MD

CONTACT

86-20-87343117Chminsh@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2011

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

CN(1)