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    Summary
    EudraCT Number:2020-003108-15
    Sponsor's Protocol Code Number:UC-GIG-2003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-08
    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 number2020-003108-15
    A.3Full title of the trial
    A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function Score
    Essai de phase II, national, multicentrique évaluant le tislelizumab en monothérapie pour des patients atteints d’un carcinome Hépatocellulaire Child-Pugh B et un score de la fonction hépatique ALBI grade 1 ou 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing immunotherapy for patients with liver cancer and moderately-altered liver functions
    Etude d’une immunothérapie chez des patients atteints de cancer du foie avec des fonctions hépatiques modérément altérées
    A.3.2Name or abbreviated title of the trial where available
    HESTIA
    A.4.1Sponsor's protocol code numberUC-GIG-2003
    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 SponsorUNICANCER
    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 supportBeiGene Switzerland GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointHead of Regulatory Affairs Dpt
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityPARIS cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33171.93.67.04
    B.5.5Fax number33153.79.02.90
    B.5.6E-mailn.ait-rahmoune@unicancer.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 No
    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 nameTislelizumab
    D.3.2Product code BGB-A317
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.3Other descriptive nameBGB-A317, BGN1, JHL2108
    D.3.9.4EV Substance CodeSUB193656
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Hepatocellular Carcinoma (HCC), Child-Pugh B, ALBI grade 1 or 2 liver function
    E.1.1.1Medical condition in easily understood language
    Liver cancer with moderately-altered liver functions
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10073069
    E.1.2Term Hepatic cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy of anti-PD1 (in terms of Objective Response Rate [ORR] based on Best Overall Response across all time-points as defined by RECIST v1.1) in the Child-Pugh B / ALBI grade 1/2 population
    E.2.2Secondary objectives of the trial
    - To assess safety of anti-PD-1
    - To assess efficacy in terms of:
    o Objective Response Rate based on best overall response across all time-point
    according to mRECIST and iRECIST tumor response evaluation
    o Overall survival (OS)
    o Progression-free survival (PFS)
    o Time to progression (TTP)
    - To assess Quality of Life according to EORTC QLQ-C30 and HCC-18
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETICS STUDY OF TISLELIZUMAB IN PATIENTS WITH CHILD-PUGH B CIRRHOSIS (Ancillary/translational study)
    OBJECTIVES: To study the pharmacokinetics of tislelizumab in the population included in HESTIA
    E.3Principal inclusion criteria
    1. Age ≥18 years old,
    2. Patient presenting with histologically-proven Hepatocellular Carcinoma (HCC),
    3. Pretreated or not by tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib, regorafenib, cabozantinib)
    4. Child-Pugh B cirrhosis
    5. ALBI (Albumin-Bilirubin) grade 1 or 2
    6. BCLC (Barcelona Clinic Liver Cancer Group) B or C
    7. Availability of biopsy specimen at study enrolment (taken within 3 months of enrolment)
    8. ECOG Performance status ≤2
    9. Adequate organ function as indicated by the following laboratory values:
    a. Patients must not have required a blood transfusion or growth factor support ≤14 days before sample collection at screening for the following:
    .Absolute neutrophil count (ANC) ≥1.5 x 109/L
    .Platelets ≥75 x 109/L
    .Hemoglobin ≥90 g/L
    b. Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate ≥60 mL/min/1.73 m2
    c. Serum total bilirubin ≤3 mg/dL.
    d. Liver function: ASAT and ALAT ≤5 ULN, albumin >2.0 g/dL
    10. Presence of measurable and evaluable disease according to RECIST v1.1
    11. Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤7 days of first dose of study drug
    12. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥120 days after the last dose of tislelizumab. A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Males with known “low sperm counts” (consistent with “sub-fertility”) are not to be considered sterile for purposes of this study.
    13. Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
    14. Patient consent to the use of their collected tumour specimen, as well as blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection.
    15. Patient affiliated to a social security regimen
    16. Men and women patients must consent to not donate or bank sperm or ova during treatment and for 120 days after treatment stop
    E.4Principal exclusion criteria
    1. No more than 50% of the liver is affected by the HCC (according to investigators evaluation)
    2. Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    3. Previous treatment with immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents)
    4. History of active autoimmune disease. Note: Patients with the following diseases are not excluded and may proceed to further screening:
    a. Type I diabetes,
    b. Hypothyroidism (provided it is managed with hormone replacement therapy only),
    c. Controlled celiac disease,
    d. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia),
    e. Any other disease that is not expected to recur in the absence of external triggering
    factors
    5. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases
    6. Any of the following cardiovascular risk factors:
    a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug
    b. Pulmonary embolism ≤ 28 days before first dose of study drug
    c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug
    d. Any history of heart failure meeting New York Heart Association (NYHA)
    Classification III or IV ≤ 6 months before first dose of study drug
    e. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug
    f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug
    g. Uncontrolled hypertension: systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications before first dose of drug
    h. Any episode of syncope or seizure before first dose of study drug
    7. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is > 500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded.
    Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled
    8. Known primary immunodeficiency or active HIV
    9. Immunosuppression, including subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) ≤ 14 days before inclusion. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
    a. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
    b. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
    c. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
    10. Live vaccine within 4 weeks of first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and Covid vaccination with non-live vaccine are allowed. Intranasal vaccines are live vaccines, and are not allowed.
    11. Transplanted liver, or patient with intent for transplantation
    12. Received locoregional therapy to the liver (TACE, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization or ablation) in the 4 weeks before inclusion
    13. Prior malignancy active within the previous 3 years of inclusion except for locally curable cancers considered cured or successfully resected, such as basal or squamous cell skin cancers, superficial bladder cancer, or gastric cancers, or carcinoma in situ of the prostate, cervix, or breast carcinomas
    14. Has received any herbal medicine used to control cancer within 14 days of the first study drug administration
    15. Pregnant woman or breast-feeding women or patient with no adequate contraception
    16. Participation in another therapeutic trial within the 30 days prior to study inclusion
    17. Patients deprived of their liberty or under protective custody or guardianship
    18. Patients unable to adhere to the protocol for geographical, social, or psychological reasons
    E.5 End points
    E.5.1Primary end point(s)
    The Objective Response Rate defined as the proportion of patients with Complete Response or Partial Response to treatment based on best overall response according to RECIST 1.1, recorded from treatment initiation to the end of treatment. Tumoral evaluation will be performed clinically, biologically, and radiologically 3 weeks before injection, then every 9 weeks during the first year and then every 12 weeks until progression. In case of complete response (CR) or partial response (PR), response must be confirmed by a second imagery at least 6 weeks later.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see above
    E.5.2Secondary end point(s)
    . Frequency of limiting toxicity (LT), defined as a serious adverse event related to the experimental drug, and leading to definitive treatment discontinuation according to the investigator, before the second injection
    . Frequency of related and not related adverse events occurring during the treatment period and until 3 months after treatment discontinuation. Adverse events will be coded and categorized according MedDRA classification and CTCAE V5.0 grade for severity.
    . Objective Response Rate defined as the proportion of patients with Complete Response or Partial Response to treatment based on best overall response according to mRECIST and iRECIST recorded from treatment initiation to the end of treatment.
    . Overall survival, defined as the time between date of inclusion and death from any cause. Patients lost to follow-up will be censored at the date of last known to be alive.
    . Progression-free survival, defined as the time between date of inclusion and disease progression or death, whichever occurs first. Disease progression will be evaluated 3 times according to RECIST v1.1, mRECIST and iRECIST, respectively. Patients lost to follow-up and patients who could benefit from secondary surgery for HCC will be censored at the date of last news and date of surgery, respectively.
    . Time to progression is defined as the time between the date of inclusion and the date of radiological progression according RECIST v1.1. Death will be censored.
    . Health Related Quality of Life according to EORTC QLQ-C30 and HCC-18
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above
    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 Yes
    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 No
    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.8.3 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 concerned14
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months52
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state50
    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
    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 Decision2022-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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