EUCTR2017-000232-34-ES进行中（未招募）1 期
A multicenter, open-label, single-arm study of the safety and antitumoral efficacy of nivolumab in combination with selective internal radiation therapy (SIRT) using SIR-Spheres for the treatment of patients with hepatocellular carcinoma that are candidates for locoregional therapies.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Age 18-years-old or above
- •Diagnosis of HCC based on histology or non-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded.
- •Chronic liver disease absent, non-viral or due to hepatitis C or B virus infection. Subjects with chronic HBV infection must be on effective antiviral therapy
- •Preserved liver function (without cirrhosis or with compensated cirrhosis in Child Pugh Class A).
- •ECOG performance status 0 or 1
- •Willing to have a liver biopsy pre-treatment
- •Considered candidates for locoregional therapy using SIR-Spheres based on
- •the absence of extrahepatic disease.
- •unsuitability for liver resection or transplantation, or percutaneous ablation
- •considered not good candidates for TACE because they have:
- •oSingle tumors larger than 5 cm. Unsuitability for TACE in patients with single tumors of size between 5 and 10 cm will follow local practice in the treating center.
- •oMultiple tumors that cannot be targeted superselectively. These patients should be in the BCLC-B2 substage proposed by Bolondi et al (3). In summary, they should fall within the up-to-7 rule (the sum of the number of tumors and the maximal size of the largest lesion in cm should be higher than 7) and should be in a Child-Pugh stage A. Unsuitability for TACE in patients with multiple tumors within the BCLC-B2 substage will follow local practice in the treating center.
- •oUnilobar tumors with segmental or lobar portal vein thrombosis. Patients that have a small burden of disease (< 10% of the total tumor burden) in the contralateral lobe may be treated at the discretion of the site Principal Investigator
- •At least one measurable lesion by RECIST 1.1 criteria.
- •Adequate organ and marrow function as evidenced by:
- •WBC = 2000/µL.
- •Neutrophils = 1000/µL.
- •Platelets = 60 x 103/µL.
- •Hemoglobin = 9.0 g/dL.
- •Creatinine CrCl >40 mL/min.
- •AST and ALT = 5 X ULN
- •Bilirubin = 2 mg/dL
- •INR = 1.8.
- •Albumin = 2.8 g/dL
- •Willing and able to comply with immune-monitoring sample collection and required study follow-up.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Any history of hepatic encephalopathy
- •Any prior (within 1 year) or current clinically significant ascites.
- •Any history of clinically meaningful variceal bleeding within the last three months.
- •Active coinfection with both hepatitis B and C or hepatitis D infection in subjects with hepatitis B
- •Occlusive main trunk portal vein thrombosis or absence of intrahepatic portal blood flow if patient carries a portocaval shunt.
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- •Any active autoimmune disease.
- •Any severe organ disease
- •Prior therapy with any drug specifically targeting T-cell costimulation or checkpoint pathways.
- •Prior organ allograft or allogeneic bone marrow transplantation
- •Recent active bacterial or fungal infections.
- •Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
研究者
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