TCTR20180410001尚未招募2 期
A PHASE II CLINICAL STUDY OF ALLOSTIM® IN SUBJECTS WITH ADVANCED HEPATOCELLULAR CARCINOMA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •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/μl
- •-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
排除标准
- •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
研究者
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