JPRN-jRCTs071200051进行中（未招募）2 期
Combination Therapy with Atezolizumab plus Bevacizumab for TACE Unsuitable Patients in Intermediate Stage Up-to-Seven Out Hepatocellular Carcinoma - a phase II study- - REPLACEMENT
Kudo Masatoshi0 个研究点目标入组 70 人开始时间: 2020年11月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Personal written informed consent is obtained after the study has been fully explained.
- •(2)Unresectable hepatocellular carcinoma
- •(3)>= 20 years of age at enrollment
- •(4)No vascular invasion / extrahepatic metastasis
- •(5)Up-to-seven out population per Clinical Practice Manual for Hepatocellular Carcinoma, fourth edition
- •(6)Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- •(7)No previous drug therapy for hepatocellular carcinoma (sorafenib, lenvatinib or immunotherapy)
- •(8)At least 1 intrahepatic target lesion according to mRECIST
- •Patients are ineligible if tumor lesion assessment by 3-phase contrast CT or 3-phase contrast MRI cannot be performed due to reasons such as allergy to contrast medium.
- •(9)No previous TACE
- •(10)Child-Pugh class A within 14 days before enrollment
- •(11)Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days before enrollment.
- •If multiple test results are available during the concerned period, the results closest to enrollment will be used. Blood transfusion or hematopoietic factor administration within 30 days before the date of measurements is not permitted.
- •i.Neutrophil count: >= 1,500/microL
- •ii.Platelet count: >= 60,000/microL
- •iii.Aspartate aminotransferase (AST): <= 5 times upper limit of normal (ULN)
- •iv.Alanine aminotransferase (ALT): <= 5 times ULN
- •v.Total bilirubin: <= 3.0 mg/dL
- •vi.Serum albumin: >= 2.8 g/dL
- •vii.Serum creatinine: <= 1.5 times ULN
- •viii.Urine protein: <= 2+
- •If >= 3+, urine protein / creatinine ratio: < 2.0 in spot urine (in case of 24-hour urine collection, urine protein < 2.0 g / 24 hr)
排除标准
- •(1)Current or recent (within 10 days before enrollment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes.
- •(2)Untreated or incompletely treated esophageal and/or varices with bleeding or high risk for bleeding; a previous bleeding event due to esophageal and/or varices within 180 days before enrollment.
- •Patients must undergo an esophagogastroduodenoscopy (EGD), and varices of all sizes (small to large) must be assessed and prophylactically treated per study site standard of care before enrollment. Patients who have undergone an EGD within 180 days before enrollment and in whom the presence of varices has been denied do not need to undergo a repeat procedure.
- •(3)Thrombosis or embolism within 180 days before enrollment
- •(4)Major surgical procedure within 28 days before enrollment (open chest, laparoscopy, thoracoscopic surgery, laparoscopic surgery, etc.); open biopsy or suturing for major trauma; or planned major surgical procedure during the study (open chest, laparoscopy)
- •(5)Treatment with systemic immunostimulatory agents (interferon, interleukin 2 [IL-2], etc.) within 180 days before enrollment
- •(6)Treatment with systemic immunosuppressive agents (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, tumor necrosis factor [TNF]-alpha agents, etc.) within 14 days before enrollment, or anticipated need for systemic immunosuppressive agents during the study treatment, with the following exceptions: treatment with mineralocorticoids (fludrocortisone, etc.) or corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, etc.
- •(7)History within 180 days before enrollment or complication of autoimmune inflammatory disease
- •(8)History of active double cancer and malignancies (synchronous malignancies, and asynchronous malignancies separated by a 3-year disease-free interval)
- •(9)Participation in a study of an unapproved drug or other interventional study (including follow-up period)
- •(10)Significant cardiovascular disease (New York Heart Association [NYHA] Class II or greater cardiac disease, myocardial infarction), unstable arrhythmias, or unstable angina within 90 days before enrollment
- •(11)Pregnant, breastfeeding, positive pregnancy test (all women who have experienced menstruation within the last year will be tested), or women and men who are unwilling to use contraception during the study
- •(12)History of hepatic encephalopathy
- •(13)Any of the following comorbidities:
- •i. Uncontrolled hypertension with or without antihypertensive agents
- •ii. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites
- •iii. Severe infection (e.g., hospitalization for complications of infection, bacteremia, or severe pneumonia) within 28 days before enrollment, except for HBV or HCV
- •iv. Human immunodeficiency virus (HIV) infection
- •v. hemodialysis by renal failure
- •(14)History of severe allergic or anaphylactic reactions or anaphylactic reactions to chimeric or humanized antibodies, or fusion proteins
- •(15)History of hypersensitivity to Chinese hamster ovary cell-derived products, or any component of atezolizumab or bevacizumab
- •(16)Otherwise unsuitable for the study in the opinion of the attending physician
研究者
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