A Phase 2b Randomized Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment. - TRAVERSE

Jennerex, Inc0 个研究点目标入组 120 人开始时间: 2011年11月22日最近更新: 2012年5月23日

适应症

试验速览

暂无简介。

•- Advanced HCC: patients are not eligible for, or had disease progression after, local-regional therapy (e.g. surgery, TACE, RFA, ethanol injection)
•- Histologic or cytologic confirmation of primary hepatocellular carcinoma (HCC)
•- Previously treated with sorafenib for ? 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression
•- Received sorafenib as the most recent therapeutic intervention
•- ECOG performance status 0, 1 or 2
•?Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Major surgery within 28 days of randomization or subcutaneous venous access device placement within 7 days prior to randomization
•- Locoregional therapy within 28 days prior to randomization
•- Received sorafenib within 14 days prior to randomization
•- Received systemic therapy other than sorafenib within 28 days of randomization
•- Prior treatment with JX-594
•- Platelet count < 50,000 PLT/ mm3
•- Total white blood cell count < 2,000 cells/mm3
•- Hematocrit < 30% and/or Hemoglobin < 10 g/dL
•- Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
•- Severe or unstable cardiac disease
•- Viable CNS malignancy associated with clinical symptoms
•- Pregnant or nursing an infant

发起方

Jennerex, Inc