A clinical study to look at how long patients with a particular type of liver cancer live for following treatment with a drug called Talaporfin sodium (LS11) that is activated by a light source, when compared to patients receiving standard treatment

Conditions: Patients with unresectable hepatocellular carcinoma
MedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864

Registration Number: EUCTR2007-004795-39-SE

Lead Sponsor: ight Sciences Oncology Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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 >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
Understanding to sign written informed consent
18 years of age or more
Adequate hematologic, liver and renal functions as evidenced by the following
WBC >2,400/mm3
Platelet Count >75,000/µl
Hemoglobin>9.4 gm/dL
PT and PTT < 1.5 Control
SGOT, SGPT < 5 x ULN
Bilirubin< 2.5 x ULN
Alk Phos < 3 x ULN
Creatinine < 2.5 mg/dL (SI:221 mol/L)
Albumin > 2 g/dl
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

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
concurrent participation in another clinical trial involving experimental treatment is excluded
Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Asses 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