A PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) IN COMBINATION WITH BEVACIZUMAB TO INVESTIGATE SAFETY AND EFFICACY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA NOT PREVIOUSLY TREATED WITH SYSTEMIC THERAPY - AMETHISTA - AMETHISTA

ROCHE SPA0 个研究点目标入组 150 人开始时间: 2021年6月17日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ROCHE SPA
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Signed Informed Consent Form;
•Age >=18 years at time of signing Informed Consent Form;
•Ability to comply with the study protocol, in the investigator's judgment;
•Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months from recruitment;
•Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies;
•No prior systemic therapy (including systemic investigational agents) for HCC;
•At least one measurable (per RECIST 1.1) untreated lesion;
•Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, SIRT etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1;
•ECOG Performance Status of 0 or 1 within 7 days prior to recruitment;
•Child-Pugh class A within 7 days prior to recruitment;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 75

排除标准

•History of leptomeningeal disease or brain metastases;
•Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
•Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
•Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
•Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
•-Rash must cover < 10% of body surface area;
•-Disease is well controlled at baseline and requires only low-potency topical corticosteroids;
•-No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months;
•History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan;
•History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
•Known active tuberculosis;
•Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;
•History of congenital long QT syndrome or corrected QT interval >500 ms (calculated with use of the Fridericia method) at screening;
•History of uncorrectable electrolyte disorder affecting serum levels of potassium, calcium, or magnesium;
•Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.

研究者

发起方

ROCHE SPA

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