A Phase 3 Study of Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma (HCC)
A Phase 3 Randomized Study to Evaluate Survival of Patients Treated With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
208
10 countries
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2006
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 19, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJanuary 30, 2015
January 1, 2015
6.2 years
July 19, 2006
January 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
130 weeks
Study Arms (2)
Litx
EXPERIMENTALDrug: Talaporfin Sodium (1 mg/kg iv), Device: Interstitial Light Emitting Diodes (200 J/cm) 3 treatments within 6 months
Standard Care
ACTIVE COMPARATORThe 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.
Interventions
LS11 (Talaporfin Sodium) slowly administered (3-5 min.) in a free flowing intravenous drip at a dose of 1 mg/kg.
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.
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.
Eligibility Criteria
You may qualify if:
- A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level \>400 ng/mL; C. Histological evidence of HCC
- ECOG Performance Status 0-2
- Life expectancy of at least 16 weeks
- Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient must have recovered from acute side effects.
- Understanding and ability to sign written informed consent
- years of age or more
- Adequate hematologic, liver and renal functions as evidenced by the following: WBC \>= 2,400/mm³ ; Platelet Count \>= 75,000/µl ; Hemoglobin \>= 9.4 gm/dL ; PT and PTT \<= 1.5 Control ; SGOT, SGPT \<= 5 × ULN ; Bilirubin \<= 2.5 × ULN ; Alk Phos \<= 3 × ULN ; Creatinine \<= 2.5 mg/dL (SI: 221 mmol/L) ; Albumin \>= 2 g/dL
You may not qualify if:
- Patients who are candidates for surgery with curative intent are not eligible
- Patients with 6 or more lesions are not eligible
- Patients with greater than 50% of parenchyma disease involvement are excluded
- Patients with Child-Pugh C cirrhosis are excluded
- Patients with diffuse HCC are excluded
- Patients with grade 3 ascites are excluded
- Evidence of major vessel invasion or extrahepatic disease is excluded. Lymph node involvement in the hilum region of the liver is eligible if the nodes do not exceed 2 cm.
- Pregnancy or breast-feeding patients are excluded. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
- Concurrent participation in another clinical trial involving experimental treatment is excluded
- Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University Hospital Dubrava
Zagreb, Croatia
Tuen Mun Hospital
Tuenmen, New Territories, Hong Kong
Prince of Wales Hospital, Dept. of Clincal Oncology
New Territories, Hong Kong
Dr. Kamakshi Memorial Hospital
Chennai, India
SMS Medical College
Jaipur, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, India
Cancer Clinic
Nagpur, 440012, India
Shatabdi Super Specialty Hospital
Nashik, India
Island Hospital
George Town, Malaysia
Lam Wah Ee Hospital
George Town, Malaysia
Hospital Universiti Kebangsaan Malaysia
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Cebu Doctors University Hospital
Cebu City, Philippines
Vicente Sotto Memorial Medical Center
Cebu City, Philippines
Santo Tomas University Hospital
Manila, Philippines
The Medical City
Pasig, Philippines
National Kidney and Transplant Institute
Quezon City, Philippines
St. Luke's Medical Center
Quezon City, Philippines
Szpital Uniwersytecki CMUJ
Krakow, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, Poland
Clinical Center of Serbia, Institute for Gastroenterology and Hepatology
Belgrade, Serbia
Clinical Center of Serbia
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Singapore General Hospital
Singapore, 169608, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Pusan National University Hospital
Busan, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Korea University Medical Center Anam Hospital
Seoul, South Korea
Kyunghee Univeristy Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Sinchon Severance Hospital, Yonsei University
Seoul, South Korea
Karolinska University Hospital
Stockholm, Sweden
Mahidol University, Siriraj Hospital
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sy-Shi Wang, PhD
Light Sciences Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2006
First Posted
July 21, 2006
Study Start
July 1, 2006
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 30, 2015
Record last verified: 2015-01