A Phase I open label/ Phase II randomized, double-blind, multicenter study investigating the combination of RAD001 and sorafenib (Nexavar®) in patients with advanced hepatocellular carcinoma - Fase I/II study: RAD001-sorafenib combination in patients with advanced hcc

ovartis0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月6日

研究概览

暂无简介。

•- Male or female patients * 18 years old with ability to take oral drugs
•- Diagnosis of advanced HCC according to the AASLD Guidelines (Bruix and Sherman 2005)
•- HCC stage B or C according to the Barcelona Clinic Liver Cancer (BCLC)
•- No previous systemic therapy for HCC
•- Measurable disease as per RECIST, that is, at least one lesion that has not been previously treated with local therapy. Previously treated lesions will be considered *non target* lesion. Local therapy must be completed at least four weeks prior to baseline scans.
•- Patients with ECOG performance status of 0 or 1
•- Cirrhotic status of current Child-Pugh class A only (5-6 points) with no encephalopathy. Child-Pugh status should be calculated based on clinical findings and laboratory results during screening period.

•- Patients currently receiving any anti cancer therapy or who have received any local anti cancer therapy *4 weeks prior to study treatment start
•- Active bleeding during the last 30 days
•- Known previous/current malignancy * 3 years except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder carcinoma
•- Known central nervous system disease
•- Known history of HIV seropositivity (HIV testing is not mandatory)
•- Any severe and/or uncontrolled medical conditions.
•- Patients receiving chronic treatment with any systemic immunosuppressive agent

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