EUCTR2017-004679-29-FR进行中（未招募）1 期
Immunotherapy in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent: French multicenter phase 2 therapeutic trial - NIVOLEP
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
- 50
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
- •Male or female patients superior or equal 18 years
- •-Histological or cytological documentation of HCC or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis
- •-Barcelona Clinical Liver Cancer (BCLC) stage Category B or C
- •-Patients with HCC amenable for EP as assessed by multidisciplinary board corresponding to the following extension:
- •oUninodular HCC >3cm and <5cm
- •oMultinodular HCC
- •-At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
- •-Liver function status Child-Pugh Class A
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status inferior or equal 2
- •-Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
- •oHemoglobin > 8.5 g/dL
- •oAbsolute neutrophil count superior or equal 1500/mm3
- •oPlatelet count superior or equal 60,000/ mm3
- •oTotal bilirubin inferior or equal 2 mg/dL
- •oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) inferior or equal 5 x upper limit of normal (ULN)
- •oSerum creatinine inferiror or equal 1.5 x ULN
- •oLipase inferiro or equal 2 x ULN
- •oProthrombine time-international normalized ratio (PT-INR) < 2.3 x ULN and PTT < 1.5 x ULN
- •oGlomerular Filtration Rate (GFR) superior or equal 30 mL/min/1.73 m2
- •-Life expectancy superior or equal 3 months
- •-Women of childbearing potential (WOCBP) need to accept one effective method of contraception until 5 months after the last nivolumab infusion
- •- Men who are sexually active with WOCBP partners need to accept one effective method of contraceptionuntil 7 months after the nivolumab infusion
- •and men must agree to use adequate contraception
- •-Patients affiliated to a Social Security System
- •-Written informed consent signed
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients with past history of HCC
- •-Patients with contraindications to EP
- •-Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate
- •-Prior liver transplantation or candidates for liver transplantation
- •-Prior systemic treatment for HCC
- •- Patients with autoimmune disease and patients requiring chronic systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications.
- •-Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention
- •-Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or non-melanoma skin cancer and superficial bladder tumors. Any cancer curatively treated > 3 years prior to study entry is permitted
- •-Known history or symptomatic metastatic brain or meningeal tumors
- •-Major surgical procedure or significant traumatic injury within 28 days before enrolment
- •-Congestive heart failure New York Heart Association superior or equal class 2
- •-Unstable angina or myocardial infarction within the past 6 months before enrolment
- •-Cardiac arrhythmias requiring anti-arrhythmic therapy
- •-Grade 3 (severe) hypertension superior or equal 180 and/or superior or equal 110 mmHG (systolic and diastolic, according to National Heart Foundation 2016)
- •-Patients with phaeochromocytoma
- •- Refractory ascites according to EASL guidelines definition (ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment)
- •-Persistent proteinuria of NCI-CTCAE version 4.0 superior or equal Grade 3
- •-Ongoing infection > Grade 2 according to NCI-CTCAE version 4.0. Hepatitis B is allowed if no active replication is present (below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is required
- •-Clinically significant bleeding NCI-CTCAE version 4.0 superior or equal Grade 3 within 30 days before enrolment
- •-Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within 6 months before enrolment
- •-Any psychological, familial, sociological, geographical or illness or medical condition that could jeopardize the safety of the patient and/or his compliance with the study protocol and follow-up procedure
- •-Known history of human immunodeficiency virus (HIV) infection
- •-Seizure disorder requiring medication
- •-Non-healing wound, ulcer or bone fracture
- •-Known hypersensitivity to the study drug or excipients in the formulation
- •-Any malabsorption condition
- •-Breast feeding
- •-Pregnancy
- •-Patient unable to swallow oral medication
研究者
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