2024-514606-31-00招募中2 期
LENVABLA Lenvatinib in neo-adjuvant and adjuvant therapy for poor-prognosis BCLC A HepatoCellular Carcinoma treated by percutaneous ablation procedure in a curative intent: multicentre pilot therapeutic trial
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- One-year local recurrence-free survival (potentially compared with historical controls, see references)
研究概览
简要总结
To assess local recurrence-free survival during a 1-year follow-up after PA procedure.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients ≥ 18 years
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory tests: o Hemoglobin > 8.5 g/dL o Absolute neutrophil count ≥ 1500/mm3 (≥ 1200/mm3 for black/African, American) o Platelet count ≥ 60,000/ mm3 o Total bilirubin ≤ 2 mg/dL o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) o Serum creatinine ≤ 1.5 x ULN o Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5 o Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
- •Life expectancy ≥ 3 months
- •Women of childbearing potential (WOCBP) need to accept one effective method of contraception until 1 month after the last lenvatinib intake and avoid pregnancy
- •Patients who are sexually active with WOCBP partners need to accept one effective method of contraception until 1 month after lenvatinib intake and men must agree to use adequate contraception
- •Patients affiliated to a Social Security System
- •Written informed consent signed
- •Patient under guardianship or curatorship
- •Satisfactory nutritional status (BMI>18 kg/m² for patients under 70 years old, or ≥21 kg/m² for the patients over 70 years old)
- •Histological or radiological diagnosis of HCC, whether new or recurrent following a prior curative therapeutic management > 6 months.
- •Barcelona Clinical Liver Cancer(BCLC) stage Category A
- •Single tumour>3 cm≤ 5cm or - Multiple tumours (max 3 lesions ≤ 3cm) or - Single tumour between 2 and 3 cm with at least one of the following characteristic: - Serum AFP>100 ng/mL - Infiltrative form - Macro-trabecular subtype (if applicable)
- •Patients with HCC amenable for PA as assessed by multidisciplinary board corresponding to the following extension: o Uninodular HCC≥ 2 cm and ≤ 5 cm, no macroscopic vascular invasion o Multinodular maximum 3 nodules ≤ 3 cm, no macroscopic vascular invasion
- •At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified RECIST for HCC
- •Absence of any portal vein thrombosis
- •Liver function status Child-Pugh Class A
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
排除标准
- •Patients with recurrence of HCC occurring less than six months after a curative treatment regarded as successful
- •Congestive heart failure New York Heart Association (NYHA) ≥ class 2
- •Unstable angina or myocardial infarction within the past 6 months before enrolment
- •Uncontrolled blood pressure to systolic BP >140mmHg or diastolic BP >90 mmHg in spite of an optimized regimen of antihypertensive medication.
- •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 ≥ Grade 3
- •Ongoing infection > Grade 2 according to NCI-CTCAE version 4.0
- •Active hepatitis B is allowed if the patient is under antiviral therapy
- •Clinically significant bleeding NCI-CTCAE version 4.0 ≥ Grade 3 within 30 days 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
- •BCLC stage >A (1 single lesion >5cm or more than 3 lesions ore multifocal HCC >3cm or vascular invasion or extra-hepatic spread)
- •Non-healing wound, ulcer or bone fracture
- •Known hypersensitivity to the study drug or excipients in the formulation
- •Any malabsorption condition
- •Breast feeding
- •Patient unable to swallow oral medication
- •Patients with contraindications to PA *Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats (in case of electroporation procedure) *Ascites *Coagulopathy *Ongoing bacterial infection
- •Patients with contraindication to contrast medium intravenous injection either gadolinium or iodinate
- •Prior liver transplantation
- •Prior systemic treatment for HCC (chemotherapy, any other TKI, immunotherapy)
- •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 tumours. Any cancer curatively treated > 3 years prior to study entry is permitted
- •Major surgical procedure or significant traumatic injury within 28 days before enrolment
结局指标
主要结局
One-year local recurrence-free survival (potentially compared with historical controls, see references)
One-year local recurrence-free survival (potentially compared with historical controls, see references)
次要结局
- - Per nodule assessment of early response (one month) after PA
- - Per nodule assessment of local recurrence
- - Per nodule assessment of intra segmental distant recurrence
- - Per nodule assessment of extra segmental distant recurrence
- - Assessment of overall recurrence-free survival at 1 and 2 years
- - Evaluation of the safety of lenvatinib administered as neo and adjuvant therapy
- - Study of tumour and non-tumour histological/molecular predictors of therapeutic response and resistance based on sequential biopsies performed before and after neo-adjuvant phase then in case of recurrence (if applicable).
- - Compliance to lenvatinib treatment
- - Consittution of a sequential biobank comprising liver tissue (if applicable) and peripheral samples (serum, plasma)
研究者
Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
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