At a glance
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A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only
In Brief
A Phase 3 clinical trial evaluating Talaporfin sodium, Percutaneous placement of device in liver metastases, and 3 other interventions for Liver Metastases and 3 related conditions. Completed, enrolled 483 participants across 57 sites in 13 countries.
Detailed Summary
The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, 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 tumor tissue inside the body.
Study Details
Timeline
Interventions
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
200 J/cm per Light Source at 20 mW/cm light energy
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan