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    Summary
    EudraCT Number:2022-000998-31
    Sponsor's Protocol Code Number:APHP220267
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-000998-31
    A.3Full title of the trial
    Study of the benefit of lenvatinib treatment in waiting list of liver transplantation after TACE failure in patients with hepatocellular carcinoma (HCC) : Ta-Len-Tra.
    NA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    Ta-Len-TRa
    Ta-Len-Tra
    A.4.1Sponsor's protocol code numberAPHP220267
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEISAI
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointMyriem CARRIER
    B.5.3 Address:
    B.5.3.1Street Address1, avenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+ 330144 84 17 52
    B.5.5Fax number+ 3301 44 84 17 01
    B.5.6E-mailmyriem.carrier@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LENVIMA 4 mg, Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderEISAI GmBH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLENVATINIB
    D.3.2Product code L01XE29
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENVATINIB
    D.3.9.1CAS number 417716-92-8
    D.3.9.4EV Substance CodeSUB64419
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a non resectable HCC registered on national waiting list for LT with no complete response to TACE as a bridging loco-regional treatment.
    NA
    E.1.1.1Medical condition in easily understood language
    NA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the proportion of LT among patients under lenvatinib with no complete response after 2 TACE.
    ND
    E.2.2Secondary objectives of the trial
    - To estimate time to progression under lenvatinib and until LT
    - To compare progression rate under lenvatinib and until LT with the theorical proportion of 20%.
    - To estimate the response rate by imaging before LT
    - To estimate the response rate by liver specimen pathology after LT
    - To estimate the recurrence rate after LT
    - To demonstrate the safety of this sequential strategy
    - Characterization of immune cell population of peripheral change under treatment.
    ND
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient presenting with
    - Non resectable HCC
    - Initial French AFP score < or = 2
    - Registered on national waiting list for LT
    - Who underwent TACE as a bridge to LT
    - With no complete response after 2 TACE (i.e. persistent active disease, including stable disease or partial response or progression)
    - Non eligible for percutaneous ablation
    - Informed, written consent obtained from the patient
    - Having the rights to French social insurance
    - Aged of 18 years or older
    - Adequate bone marrow, liver and renal function as assessed by the following laboratory tests:
    * Hemoglobin > 8.5 g/dL
    * Absolute neutrophil count ≥ 1500/mm3 (≥ 1200/mm3 for black/African, American)
    * Platelet count ≥ 60,000/ mm3
    * Total bilirubin ≤ 2 mg/dL or 34 mcmol/l
    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)
    * Serum creatinine ≤ 1.5 x ULN
    * Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 50 %
    * Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
    - 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.
    ND
    E.4Principal exclusion criteria
    - Contraindication of lenvatinib and excipient
    1- Cardiovascular:
    * Rhythmic or ischemic recent or uncontrolled cardiac disease: Pacemakers or patients who have a history of cardiac arrhythmias or irregular heartbeats (in case of electroporation procedure)
    * Congestive heart failure New York Heart Association (NYHA) ≥ class 2
    * Unstable angina or myocardial infarction within the past 6 months before enrolment
    * Uncontrolled arterial hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
    2- Ongoing ascites: 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)
    3- Coagulopathy
    4- Ongoing infection > Grade 2 according to NCI-current CTCAE . Hepatitis B is allowed if no active replication is present (below 100 IU/mL). Hepatitis C is allowed if no antiviral treatment is ongoing
    - Known hypersensitivity to the study drug or excipients in the formulation
    - Decompensated cirrhosis (Child-Pugh > A6)
    - Prior systemic therapy with oral TKI and/or immunotherapy
    - 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
    - Recent digestive bleeding associated with portal hypertension (whithin the 3 months prior to inclusion in the study)
    - Advanced or Metastatic HCC (BCLC C)
    - Persistent proteinuria of NCI-current CTCAE ≥ Grade ≥ Grade 3
    - Project of living donor
    - Pregnant or lactating woman
    - Curator or guardianship or patient placed under judicial protection
    - Participation in other interventional research during the study .
    ND
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with TACE failure and treated with lenvatinib who have a LT.
    ND
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time of the LT
    E.5.2Secondary end point(s)
    - Time to progression under lenvatinib before LT by imaging. Progression will be based on RECIST and mRECIST.
    - Progression under lenvatinib before LT by imaging. Progression will be based on RECIST and mRECIST.
    - Response rate before LT by imaging
    - Response rate by liver specimen pathology after the LT
    - Recurrence rate after LT by imaging
    - Evaluate Safety by AE and SAE (using current CTCAE )
    The endpoints associated to the immunophenotyping of peripheral blood immune cell population will be on the ancillary analyses.
    ND
    E.5.2.1Timepoint(s) of evaluation of this end point
    - within 12 months of treatment for imaging and safety and immunophenotyping
    - at the time of transplantation for histological characterization
    - within 18 months after LT for imaging recurrence.
    ND
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Non
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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