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)
Patients who provide Informed Consent and satisfy the Eligibility Criteria will be placed in
an eligibility pool for randomization for either the Litx™ treatment arm or the standard of
A Patient assigned to the Litx™ treatment group may receive up to three Litx™ treatments.
Regardless of which group the patient is assigned the treatment planning should anticipate
ablation of all lesions with three Litx™ treatments using up to 4 Light Sources per
treatment (a single Light Source may kill 2 cm x 4 cm of tissue).
The 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. Following imaging confirmation of Light Source
placement, patients will receive an intravenous dose of LS11 at 1 mg/kg. Fifteen minutes to
one hour following completion of LS11 administration, delivery of 200 J/cm per Light Source
at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the
patients will be observed for any complication after Light Source removal. Precautions for
protection from external light exposure should be instituted beginning with the LS11
administration and maintained for up to two weeks.
Patients designated for the standard of care group, will receive current standard of care
treatment recommended by the investigating physician. Should the elected treatment fail, a
patient may switch to another standard of care treatment.
A patient designated for the Litx™ treatment group may receive up to two additional Litx™
treatments. A second and third treatment with Litx™ may be considered if any residual tumor
or new tumor exists. The third treatment must take place within six months after the first
treatment. A patient may switch to receiving standard of care after the third Litx™
treatment or as recommended by the investigator as necessary.
For either the Litx™ group or standard of care group once all treatment therapies have been
exhausted the patient will be followed for survival. No protocol-directed office visits are
required during this period and the patient may be followed by phone and/or e-mail at four
week intervals. All patients will be monitored for survival from the time of randomization
to the time of death from any cause or until at least 142 deaths have been observed,
whichever occurs first.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sy-Shi Wang, PhD
Light Sciences Oncology
United States: Food and Drug Administration