JPRN-jRCT2080223750已完成1 期
An Open-Label, Multicenter Phase Ib Study of The Safety and Efficacy of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab and/or Other Treatments in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 223
研究概览
简要总结
The study results suggested that the combination of atezolizumab with bevacizumab results in durable antitumour responses and significantly improved progression-free survival compared with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Measurable disease per RECIST v1.1
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Adequate hematologic and end organ function
- •- Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than or equal to (- Ready to use reliable contraceptive procedures
排除标准
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites
- •- Uncontrolled tumor-related pain
- •- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •- Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
- •- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant human antibodies
- •- Positive test for Human Immunodeficiency Virus (HIV)
- •- Active tuberculosis
- •- Severe infections within 4 weeks prior to Day 1
- •- Signs or symptoms of significant infection within 2 weeks prior to Day 1
- •- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- •- Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Day 1, unstable arrhythmias, or unstable angina
- •- History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to Day 1
- •- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- •- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study
- •- Malignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS >90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
研究者
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