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Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)

NCT02112656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2024-08-20

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 standardized radiofrequency ablation (sRFA).

Conditions

Interventions

DRUG

ThermoDox

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

DRUG

Dummy infusion

Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Ricardo Lencioni, MD · University of Pisa

  • Ronnie Tung Ping Poon, MD · Hong Kong University

  • Chen Min Hua, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-04-27
Completion
2020-04-27

Countries

  • United States
  • Canada
  • China
  • Germany
  • Hong Kong
  • Italy
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Vietnam

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 NCT02112656 on ClinicalTrials.gov