A
- Conditions
- ATherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005504-18-FR
- Lead Sponsor
- Assistance Publique – Hôpitaux de Paris (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
Male or female patients = 18 years
-Histological diagnosis of HCC, whether new or recurrent following a prior curative therapeutic management > 6 months.
- Barcelona Clinical Liver Cancer(BCLC) stage Category A
- Comprising at least one of the following the following characteristics:
- Serum AFP>100 ng/mL
- Infiltrative form
- Macro-trabecular subtype
-Patients with HCC amenable for PA as assessed by multidisciplinary board corresponding to the following extension:
oUninodular HCC= 2 cm and = 5 cm, no macroscopic vascular invasion
oMultinodular 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
-Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
oHemoglobin > 8.5 g/dL
oAbsolute neutrophil count = 1500/mm3
(= 1200/mm3 for black/African, American)
oPlatelet count = 60,000/ mm3
oTotal bilirubin = 2 mg/dL
oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 x upper limit of normal (ULN)
oSerum creatinine = 1.5 x ULN
oProthrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 1.5
oGlomerular 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)der
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Patients with recurrence of HCC occurring less than six months after a curative treatment regarded as successful
- BCLC stage >A (1 single lesion >5cm or more than 3 lesions ore multifocal HCC >3cm or vascular invasion or extra-hepatic spread)
- 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 or candidates for liver transplantation
- Prior systemic treatment for HCC (chemotherapy, any other TKI, immunotherapy)
-Patients with large oesophageal 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
-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. 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 = 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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method