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)

ight Sciences Oncology Inc.0 个研究点目标入组 200 人开始时间: 2008年4月21日最近更新: 2012年10月22日

适应症

试验速览

暂无简介。

•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

•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

发起方

ight Sciences Oncology Inc.