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A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

NCT00355355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2015-01-30

No results posted yet for this study

Summary

The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.

Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.

Conditions

  • Carcinoma, Hepatocellular
  • Liver Neoplasms

Interventions

DRUG

Talaporfin sodium

LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.

DEVICE

Interstitial Light Emitting Diodes

200 J/cm per Light Source at 20 mW/cm light energy

PROCEDURE

Percutaneous placement of device in the liver

Litx™ treatment group undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Source(s) may be used in a single lesion or in multiple lesions.

PROCEDURE

Standard Care

The standard of care could include any one of the following treatment options: Percutaneous Ethanol Injection (PEI), Transcatheter Arterial Chemoembolization (TACE), Radio Frequency Ablation (RFA), Cryotherapy, Systemic Chemotherapy, or other modalities that may be used at a particular institution.

Sponsors & Collaborators

  • Light Sciences Oncology

    lead INDUSTRY

Principal Investigators

  • Sy-Shi Wang, PhD · Light Sciences Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Croatia
  • Hong Kong
  • India
  • Malaysia
  • Philippines
  • Poland
  • Serbia
  • Singapore
  • South Korea
  • Sweden
  • Thailand

Study Locations

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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 NCT00355355 on ClinicalTrials.gov