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Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)

NCT00617981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2024-05-03

Study results available
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Summary

The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with radiofrequency ablation (RFA).

Conditions

Interventions

DRUG

ThermoDox

Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion

DRUG

5% Dextrose Solution

Single 30 minute intravenous infusion

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Ronnie T Poon, M.D. · Queen Mary Hospital, University of Hong Kong

  • Riccardo Lencioni, M.D. · University of Pisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-01-31
Completion
2016-08-31

Countries

  • United States
  • Canada
  • China
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617981 on ClinicalTrials.gov