TCTR20201208004尚未招募2 期
A Phase II/III Randomized, Controlled Clinical Study of AlloStim® vs. Physician’s Choice in Asian Subjects with Advanced Hepatocellular Carcinoma.
Dr. Michael Hay-Nor0 个研究点目标入组 150 人开始时间: 2020年12月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
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 75 Years（—）
- 性别
- All
入选标准
- •1. Male or Female ≥18yo and ≤ 75yo with histologically or radiologically confirmed hepatocellular carcinoma (HCC).
- •1.1 Non-resectable disease
- •1.2 not amenable to local therapy with curative intent (surgery, radiation, ablation,
- •1.3 With or without positive Hepatitis B Virus HBV and/or Hepatitis C Virus (HCV)
- •2. BCLC stage C disease with no prior treatment
- •2.1 Not eligible for, or unable to obtain access to first line: sorafenib or lenvatinib.
- •2.2 With or without extrahepatic disease
- •3. Child-Pugh Class A or Class B
- •3.1 with or without macrovascular invasion (MVI)
- •4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
- •4.1 with no deterioration over the previous 2 weeks
- •5. Measurable enhancing disease in liver (mRECIST)
- •6. Adequate liver and renal function as assessed by the following:
- •6.1 Hemoglobin > 10.0 g/dl
- •6.2 Platelet count > 75,000/μl
- •6.3 ALT and AST < 5 x ULN
- •6.4 Alkaline phosphatase < 4 x ULN
- •6.5 Serum creatinine < 1.5
- •7. Women of child-bearing potential o negative pregnancy test
- •7.1 usage of contraception or avoidance of pregnancy measures while enrolled on study
- •8. Ability to regularly visit the research institutions per protocol for related tests, evaluations, and management during the study period.
- •9. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
- •9.1 Travel stipend allowed
排除标准
- •1.Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma).
- •2. Prior exposure to checkpoint inhibitors (PD-1/PD-L1 or CTLA4)
- •3. Enrollment in any previous clinical trial for HCC
- •4. Received or undergone any prior procedures, medications or treatments for HCC
- •5. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
- •6. International normalized ratio (INR) >1.7 (+2 or +3 on Child-Pugh calculator)
- •7. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy
- •7.1 >grade 1 (+2 or +3 on Child-Pugh calculator)
- •8. Score of >9 on Child-Pugh calculator (class C)
- •9. Severe stomach/esophageal varices requiring interventional treatment.
- •10. Clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •11. History of Chronic obstructive pulmonary disease (COPD) or oxygen saturation <95% on room air
- •12. Unable to tolerate contrast dye
- •13. History of any autoimmune (including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, ankylosing spondylitis, Crohn’s disease, Addison’s disease, Grave’s disease, Sjogren’s syndrome, myasthenia gravis and autoimmune vasculitis, autoimmune hepatitis, uveitis) o Type I diabetes allowed
- •13.1 If no active disease in the last 5 years may be included but only after consultation with the study physician and medical monitor.
- •13.2 Patients with celiac disease controlled by diet alone allowed
- •14. Current chronic inflammatory disorder (including: inflammatory bowel disease, colitis, Hashimoto’s thyroiditis)
- •15. Any clinical condition requiring systemic steroids or current immunosuppressive therapy o Inhaled steroids allowed
- •16. Known history of HIV positive
- •17. History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; cardiac arrhythmias requiring anti-arrhythmic therapy o beta blockers or Digoxin are permitted
- •18. History of stroke or pulmonary embolism within 1 year of accrual
- •19. Active clinically serious infections (> grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version 5)
- •20. History of organ or tissue allograft
- •21. Uncontrolled concurrent serious medical or psychiatric illness
- •22. Clinically apparent central nervous system metastases or carcinomatous meningitis
- •23. History of blood transfusion reactions
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