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)

ight Sciences Oncology Inc.0 个研究点目标入组 200 人开始时间: 2008年3月11日最近更新: 2012年10月16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 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.

发起方

ight Sciences Oncology Inc.