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

PHASE3CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Carcinoma, HepatocellularLiver 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.

Trial Locations (34)

169608

Singapore General Hospital, Singapore

169610

National Cancer Centre, Singapore

440012

Cancer Clinic, Nagpur

Unknown

University Hospital Dubrava, Zagreb

Tuen Mun Hospital, Tuenmen

Prince of Wales Hospital, Dept. of Clincal Oncology, New Territories

Dr. Kamakshi Memorial Hospital, Chennai

SMS Medical College, Jaipur

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

Shatabdi Super Specialty Hospital, Nashik

Island Hospital, George Town

Lam Wah Ee Hospital, George Town

Hospital Universiti Kebangsaan Malaysia, Kuala Lumpur

University Malaya Medical Centre, Kuala Lumpur

Cebu Doctors University Hospital, Cebu City

Vicente Sotto Memorial Medical Center, Cebu City

Santo Tomas University Hospital, Manila

The Medical City, Pasig

National Kidney and Transplant Institute, Quezon City

St. Luke's Medical Center, Quezon City

Szpital Uniwersytecki CMUJ, Krakow

Centralny Szpital Kliniczny MSWiA, Warsaw

Clinical Center of Serbia, Institute for Gastroenterology and Hepatology, Belgrade

Clinical Center of Serbia, Belgrade

Military Medical Academy, Belgrade

Pusan National University Hospital, Busan

Seoul National University Bundang Hospital, Gyeonggi-do

Korea University Medical Center Anam Hospital, Seoul

Kyunghee Univeristy Medical Center, Seoul

Samsung Medical Center, Seoul

Sinchon Severance Hospital, Yonsei University, Seoul

Karolinska University Hospital, Stockholm

Mahidol University, Siriraj Hospital, Bangkok

Chiang Mai University, Chiang Mai

Sponsors
All Listed Sponsors
lead

Light Sciences Oncology

INDUSTRY