A PHASE II CLINICAL STUDY OF ALLOSTIMÂ® IN SUBJECTS WITH ADVANCED HEPATOCELLULAR CARCINOMA

Immunovative Therapies Ltd.0 个研究点目标入组 30 人开始时间: 2018年4月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Males and females who are at least 18 years of age at time of enrollment
•2.With or without positive HBV and/or HCV
•3.BCLC stage C disease with no prior treatment or no longer benefiting from prior locoregional therapy
•4.With or without extrahepatic disease and with or without macrovascular invasion
•5.Child-Pugh Class A
•6.Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
•7.Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST
•8.One liver lesion in a location safely amenable for longitudinal percutaneous biopsy (can be same as target lesion)
•9.Adequate hematological, liver and renal function as assessed by the following:
•-Hemoglobin > 10.0 g/dl
•-Platelet count > 75,000/Î¼l
•-ALT and AST < 5 x ULN
•-Alkaline phosphatase < 4 x ULN
•-Serum creatinine < 1.5
•10.Women of child-bearing potential: negative pregnancy test
•11.Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study
•12.Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate

•1.Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
•2.Clinical symptoms of encephalopathy
•3.INR > 1.5
•4.Unable to tolerate radiological contrast dye
•5.Prior first line or second line treatment for BCLC stage C disease, including checkpoint blockade, sorafenib, levantinib or regorafinib or other experimental or off-label treatments or procedures
•6.Any autoimmune disorder
•7.Any clinical condition requiring systemic steroids or any current immunosuppressive therapy
•8.HIV positive
•9.History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension
•10.Active clinically serious infections (> grade 2 CTCAE version 4.03)
•11.History of organ transplant or tissue allograft
•12.Uncontrolled concurrent serious medical or psychiatric illness
•13.Clinically apparent central nervous system metastases or carcinomatous meningitis
•14.History of blood transfusion reactions

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