Patients with unresectable hepatocellular carcinoma MedDRA version: 14.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: talaporfin sodium
Product Code: LS11
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Talaporfin Sodium
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Light Sciences Oncology Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy, Poland, Sweden
Contacts
Public ContactRegulatory Affairs
Light Sciences Oncology, Inc.
Outcome results
None listed