A Phase 1/2 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LEDs) in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma (HCC)
Subjects that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT
or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources
depending on their tumor characteristics. 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. Depending on lesion size, one or more Light Sources may be used to treat a single
Following ultrasound or CT confirmation of the Light Sources, patients will receive an
intravenous dose of LS11 at 1 mg/kg. 15 minutes to 1 hour following completion of LS11
administration, delivery of 200 J/cm light energy at 20 mW/cm will begin. Upon completion of
light treatment, the Light Sources will then be manually removed and the patients will be
observed for acute complications.
Subjects will be evaluated for treatment-related adverse events at every scheduled clinical
visit. Restaging by contrast enhanced spiral CT and tumor evaluation, using the RECIST
criteria, are performed at Week 4 and Week 8.
Subjects may receive a second Litx™ treatment at Week 4 or Week 8, as recommended by the
study investigator. Subjects who receive the second Litx™ treatment will be evaluated for
treatment-related adverse events at every scheduled clinical visit. Restaging by contrast
enhanced spiral CT and tumor evaluation, using the RECIST criteria, are performed. The
active phase of the protocol ends 8 weeks after the last treatment received.
Following completion of the active phase of the protocol, subjects will be monitored for
survival for one year (at 6, 9 and 12 month time points) from the date of study entry or
until death, whichever occurs first.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sy-Shi Wang, PhD
Light Sciences Oncology
Hong Kong: Department of Health