A Phase III Randomised 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)
- Conditions
- Patients with unresectable hepatocellular carcinomaMedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2007-004795-39-PL
- Lead Sponsor
- ight Sciences Oncology Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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 >400ng/mL
C. Histological evidence of HCC
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.
ECOG Performance Status 0-2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who are candidates for complete surgical resection 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
Known sensitivity to porphyrin-type drugs or known history of porphyria are exclusionary
Pregnant or breast-feeding patients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the survival of patients treated with Litx TM versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC). Demonstrate the safety of Litx TM therapy.;Secondary Objective: Assess the survival of a subset of patients in the Litx group who received Litx TM treatment followed by the standard of care versus patients in the standard of care group for the treatment of unresectable hepatocellular carcinoma (HCC);Primary end point(s): Overall survival
- Secondary Outcome Measures
Name Time Method