EUCTR2017-003691-31-CZ进行中（未招募）1 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB IN COMBINATION WITH BEVACIZUMAB COMPARED WITH SORAFENIB IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
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
入选标准
- •- Age >= 18 years
- •- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients
- •- 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 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 v1.1
- •- Pre-treatment tumor tissue sample (if available)
- •- ECOG Performance Status of 0 or 1 within 7 days prior to randomization
- •- Child-Pugh class A within 7 days prior to randomization
- •- 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
- •- Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
- •- For patients with active hepatitis B virus, HBV DNA 500 IU/mL obtained within 28 days prior to initiation of study treatment and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib. Women must refrain from donating eggs during this same period.
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 6 months after the last dose of bevacizumab or 3 months after the last dose of sorafenib
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- History of leptomeningeal disease, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- •- Active or history of autoimmune disease or immune deficiency,
- •- Known active tuberculosis, moderate or severe ascites
- •- Significant cardiovascular disease 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 at screening and uncorrectable electrolyte disorder affecting serum level 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
- •- 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 and hepatic encephalopathy
- •- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- •- Prior allogeneic stem cell or solid organ transplantation, Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti- cytotoxic T-lymphocyte-associated protein 4, anti- Programmed death (PD)-1, and anti-PD-Ligand 1 therapeutic antibodies
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
- •- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation
- •- Fibrolamellar and sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
- •- Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
- •- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- •- Co-infection of hepatitis B and C virus
- •- Symptomatic, untreated, or actively progressing central nervous system metastases
- •- Uncontrolled tumor-related pain
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •- Uncontrolled or symptomatic hypercalcemia
- •- Treatment with investigational therapy within 28 days prior to study treatment,
- •- Treatment with strong CYP3A4 inducers within 14 days prior to study treatment
- •- Treatment with systemic immunostimulatory agents and immunosuppressive medic
研究者
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