NCT04487067已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 21
- 主要终点
- Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage
研究概览
简要总结
This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 for HCC;
- •At least one measurable untreated lesion;
- •Patients who received prior local therapy 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;
- •Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed. In case of varices at high risk of bleeding (corresponding to medium (F2) or large (F3) varices, or F1 varices with cherry red spots or red wale marking) prophylatic treatment per local standard of care must be adopted prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure provided they had no varices at high risk of bleeding;
- •Adequate hematologic and end-organ function
- •Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade <= 1 prior to study entry, with the exception of alopecia
- •Negative HIV test at screening with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200µL, and have an undetectable viral load;
- •In patients with viral HCC, documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test;
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
排除标准
- •History of leptomeningeal disease or brain metastases;
- •Active or history of autoimmune disease or immune deficiency;
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan;
- •Known active tuberculosis;
- •Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;
- •History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death;
- •Prior allogeneic stem cell or solid organ transplantation;
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab and 6 months after the last dose of bevacizumab;
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding;
- •A prior bleeding event due to oesophageal and/or gastric varices within 6 months prior to initiation of study treatment;
- •Clinically evident ascites;
- •Co-infection of HBV and HCV;
- •Co-infection with HBV and hepatitis D viral infection;
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
- •Clinically significant uncontrolled or symptomatic hypercalcemia;
- •Inadequately controlled arterial hypertension;
- •Significant vascular disease within 6 months prior to initiation of study treatment;
- •History of haemoptysis;
- •Evidence of bleeding diathesis or significant coagulopathy;
- •History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment;
- •History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment;
- •Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume;
- •Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure.
研究组 & 干预措施
Atezolizumab + Bevacizumab
Experimental
Participants will receive atezolizumab 1200 mg intravenous (IV) infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg IV Q3W (dosed in 3-week cycles)
干预措施: Atezolizumab (Drug)
Atezolizumab + Bevacizumab
Experimental
Participants will receive atezolizumab 1200 mg intravenous (IV) infusions Q3W (dosed in 3-week cycles) + bevacizumab 15 mg/kg IV Q3W (dosed in 3-week cycles)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage
时间窗: Up to approximately 47.6 months
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AEs was graded using NCI CTCAE v5.0. Grade 3=Severe/medically significant but not immediately life-threatening, hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=Death related to AE.
次要结局
- Overall Survival (OS)(Up to approximately 47.6 months)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to approximately 47.6 months)
- Progression-free Survival (PFS)(Up to approximately 47.6 months)
- Objective Response Rate (ORR)(Up to approximately 47.6 months)
- Time to Progression (TTP)(Up to approximately 47.6 months)
- Duration of Response (DOR)(Up to approximately 47.6 months)
- Post-progression Survival (PPS)(Up to approximately 47.6 months)
- Number of Participants Reporting Severe Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire(From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days))
- Number of Participants Reporting Very Severe Symptoms in PRO-CTCAE Questionnaire(From Cycle 1 Day 1 to Cycle 63 Day 1 (1 Cycle = 21 days))
研究者
研究点 (21)
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