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The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

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ClinicalTrials.gov Identifier: NCT04803994
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Tracking Information
First Submitted Date  ICMJE March 15, 2021
First Posted Date  ICMJE March 18, 2021
Last Update Posted Date December 21, 2021
Actual Study Start Date  ICMJE July 6, 2021
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
Time to failure of treatment strategy [ Time Frame: 48 months - assessed every 8 weeks (±7days) ]
The primary endpoint is defined as the time from randomization until death or need for a further therapeutic option, defined for each arm as follows:
  • Arm A: Time from randomization until the failure of strategy does not allow for further treatment with atezolizumab + bevacizumab; or death, whichever comes first.
  • Arm B: Time from randomization until the failure of strategy does not allow for further TACE therapy; or death, whichever comes first.
Failure of strategy (in brief): failure of strategy is reached in case of progressive disease accompanied by any of the following: loss of clinical benefit, unacceptable toxicity, liver function deterioration, therapy not further applicable for other reasons.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • Overall survival (OS) [ Time Frame: 48 months ]
    Time from the date of randomization until the date of death due to any cause. A subject who has not died will be censored at last known date alive.
  • Overall Survival Rate at 24 months (OS@24) [ Time Frame: 24 months ]
    The proportion of patients assigned to a treatment arm known to be alive at 24 months after randomization.
  • Objective Response Rate (ORR) [ Time Frame: 48 months ]
    The proportion of patients assigned to a treatment arm with a confirmed best response of Complete Response (CR) or Partial Response (PR). Response will be assessed according to HCC mRECIST.
  • Time to Progression (TTP) [ Time Frame: 48 months ]
    Time from the date of randomization until the date of first objective disease progression. Subjects who have not progressed will be censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy. Subjects who die without experiencing a progress first will be censored on their date of death.
  • Time to loss of systemic treatment options (TTSYS) [ Time Frame: 24 months ]
    Time from the date of randomization until the date the patient reaches a state of being unfit for any subsequent systemic treatment option (BSC as only option left) or the date of death whichever occurs first. Subjects who end systemic treatment at their own request will be censored at the day of end of systemic treatment. Subjects who are lost to follow-up will be censored at the date last known to be systemically treated.
  • Progression free survival (PFS) [ Time Frame: 48 months ]
    Time from the date of randomization until the date of first objective disease progression or death. Subjects who did not progress or die will be censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.
  • Duration of Treatment [ Time Frame: 24 months ]
    From start of treatment to permanent discontinuation of the treatment arms A and B.
  • Duration of Response (DOR) [ Time Frame: 48 months ]
    Time from initial response to progressive disease or death in patients in treatment arms A and B with a confirmed best response of Complete Response (CR) or Partial Response (PR) according to HCC mRECIST. Subjects who did not progress or die will be censored at the last evaluable tumor assessment date prior to subsequent anti-cancer therapy.
  • Time to deterioration of liver function [ Time Frame: 48 months ]
    Time from the date of randomization until liver function deterioration is registered according to definition given for failure of strategy. Only patients experiencing a deterioration of liver function are included into this analysis
  • Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0 [ Time Frame: 48 months ]
    Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.
  • QoL (EORTC QLQ-C30 and HCC18 sub-questionnaire) [ Time Frame: 48 months ]
    QoL mean values and response as well as time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 15, 2021)
  • Exploratory endpoint - Correlation of biomarkers for study endpoints [ Time Frame: 48 months ]
    Tissue, blood and stool samples will be collected to identify prognostic and predictive angiogenic and immune related biomarkers (tissue and circulating) for study endpoints.
  • Exploratory endpoint - PD-L1 expression [ Time Frame: 48 months ]
    PD-L1 expression will be analyzed by immunohistochemistry on available FFPE tissue samples
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Official Title  ICMJE The ABC-HCC Trial: A Phase IIIb, Randomized, Multicenter, Open-label Trial of Atezolizumab Plus Bevacizumab Versus Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Brief Summary The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.
Detailed Description

The main purpose of this phase IIIb study is to test the efficacy and safety of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer.

Primary efficacy objective is to assess the efficacy of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer.

The secondary efficacy objective is to further characterize the responses obtained with the respective therapeutic strategy and to assess the impact of each therapeutic strategy on liver function over time.

Furthermore the objective is to evaluate the safety and tolerability of each therapeutic strategy and their respective impact on Quality of Life and to identify prognostic and predictive angiogenic and immune related biomarkers (tissue and circulating) for study endpoints.

This is a Phase IIIb, randomised, multicenter, open-label study. Approximately 434 patients suffering from intermediate-stage hepatocellular carcinoma will be enrolled in this trial. Patients will be recruited from up to 60 sites in 10 different countries.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Clinical trial with two study arms:

Experimental arm A: 50% of the patients will receive a combination therapy (systemic) of the monoclonal antibodies atezolizumab and bevacizumab.

Control arm B: 50% of the patients will receive TACE therapy (locoregional).

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Atezolizumab
    1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)
    Other Name: Tecentriq
  • Drug: Bevacizumab
    15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)
    Other Name: Avastin
  • Procedure: TACE
    Locoregional therapy will be performed as a standard-of-care procedure
    Other Name: transarterial chemoembolization
Study Arms  ICMJE
  • Experimental: Systemic therapy with atezolizumab + bevacizumab

    Patients receive atezolizumab 1200 mg flat dose plus bevacizumab 15 mg/kg given intravenously every 3 weeks until failure of strategy, participant request, or withdrawal of consent for a maximum of up to 24 months.

    The discontinuation of one of the study drugs for toxicity reasons does not qualify as failure of treatment strategy as long as the other drug can be continued according to protocol.

    Interventions:
    • Drug: Atezolizumab
    • Drug: Bevacizumab
  • Active Comparator: Locoregional therapy with TACE

    Patients will receive initial TACE and - if required to achieve or improve an objective response - a second TACE after 8 weeks (±7 days window). Thereafter, additional TACE can be applied on demand until failure of strategy, participant request, or withdrawal of consent for a maximum of up to 24 months.

    TACE must be discontinued in cases of technical difficulties making additional TACE impossible.

    Only conventional TACE (cTACE) and drug-eluting bead TACE (DEB-TACE) approaches are accepted as TACE therapy. However, consistency in the TACE procedure and the use of the chemotherapeutic agent has to be maintained for each individual patient.

    Intervention: Procedure: TACE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2021)
434
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2025
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed Informed Consent Form available
  2. Patients ≥ 18 years of age at time of signing Informed Consent Form (for Taiwan: ≥ 20 years)
  3. Confirmed hepatocellular carcinoma diagnosis based on histopathological findings from tumor tissue or typical diagnostic imaging on dynamic CT or MRI according to AASLD criteria.
  4. Disease not amenable to curative surgery or transplantation or curative ablation BUT disease amenable to TACE
  5. Extent of disease according to the following parameters:

    • Multifocal HCC beyond Milan criteria (i.e. >3 lesions of any size OR ≥2 lesions with at least one of them being ≥ 3cm)
    • More than one untreated HCC untreated nodule > 10 mm showing arterial hyperenhancement
    • No massive multinodular pattern preventing adequate TACE
    • No tumor of a diffuse infiltrative HCC type
    • Patent portal vein flow
    • No portal vein invasion/thrombosis (even segmental) on baseline/eligibility imaging
    • No extrahepatic disease
  6. Patients with recurrence after resection/ablation are eligible if initially having achieved complete response AND recurrence developed within 2 years (i.e. ≤730 days) before trial inclusion AND if ≥ 2 untreated nodules with > 10 mm with arterial enhancement are present at timepoint of trial inclusion.
  7. Child-Pugh score class A without ascites requiring more than 100 mg of spironolactone/day (see exclusion criteria) at enrollment.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 at enrollment.
  9. Adequate organ and bone marrow function
  10. Life expectancy of ≥ 3 months
  11. The following laboratory values obtained less than or equal to 7 days prior to randomization.

    • Platelet count ≥ 75,000 per µL (75x109/L)
    • Hemoglobin ≥ 9.0 g per dL [transfusion allowed]
    • Total bilirubin ≤ 2.0 x the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN
    • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) ≥ 50mL/min (calculated using the Cockcroft-Gault formula)
    • Urine dipstick for proteinuria ≤ 2+ (within 7 days prior to initiation of study treatment) Patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1 g of protein in 24 hours
    • INR or aPTT ≤ 1.5 x ULN (therapeutic anticoagulation prohibited - see exclusion criterion #13; prophylactic anticoagulation permitted, e.g. LMW heparin, ASS up to 250mg/qd)
    • Alkaline phosphatase ≤ 2.5 x ULN
    • Absolute neutrophil count (ANC) ≥ 1.500 per µL (1.5x109/L) without granulocyte colony-stimulating factor support
    • Serum albumin ≥ 2.8 g per dL (28g/L)
  12. Pre-treatment tumor tissue sample (if available)

    • If tumor tissue is available, a formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or approximately 10 to 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report.
    • If FFPE specimens described above are not available, any type of specimens (including fine-needle aspiration, cell pellet specimens [e.g., from pleural effusion], and lavage samples) are also acceptable. This specimen should be accompanied by the associated pathology report.
    • If tumor tissue is not available (e.g., patient has never undergone biopsy or tissue depleted because of prior diagnostic testing), patients are still eligible.
  13. Negative serum pregnancy test done lesser than or equal to 7 days prior to randomization, for females of childbearing potential only.
  14. No presence of untreated or incompletely treated varices with bleeding or high-risk for bleeding: Availability of esophagogastroduodenoscopy (not older than 6 months) in which all size of varices (small to large) had been assessed and varices were treated per local standard of care prior to enrollment.
  15. Absence of other severe comorbidities
  16. Resolution of any acute, clinically significant treatment-related adverse events from prior therapy/procedure to Grade ≤ 1 prior to study entry, with the exception of alopecia.
  17. For patients with active hepatitis B virus (HBV):

    • HBV DNA ≤500 IU/mL obtained within 28 days prior to initiation of study treatment, AND
    • Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.
  18. For patients with active hepatitis C virus (HCV):

    • Patients positive for hepatitis C virus (HCV) antibody are eligible, also if polymerase chain reaction testing is positive for HCV ribonucleic acid (RNA).
    • However, anti-viral therapy against HCV is only allowed prior to trial but not during the trial.
  19. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last TACE procedure.

    • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
    • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  20. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:

    • With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of bevacizumab or 1 month after the last TACE procedure. Men must refrain from donating sperm during this same period.
    • With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of bevacizumab or 1 month after the last TACE procedure to avoid exposing the embryo.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria:

  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  2. Disease still amenable to curative surgery or transplantation or curative ablation.
  3. Previous treatment with atezolizumab or bevacizumab.
  4. Previous treatment with a programmed death 1 (PD1), programmed death-ligand (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of cancer immunotherapy for HCC.
  5. Previous TACE or any other transarterial treatment for HCC

    • Previous RFA / MWA allowed (refer to inclusion criterion #6)
    • Other local therapies are prohibited (e.g. cryoablation, high-intensity focused ultrasound, irreversible electroporation)
  6. Extent of disease too advanced:

    • Evidence of macrovascular invasion (even segmental) on baseline / eligibility imaging
    • Massive multinodular pattern preventing adequate TACE
    • Extrahepatic disease
  7. Tumor of diffuse infiltrative HCC type (hypovascular infiltrative tumors with ill-defined borders)
  8. Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.

    • Patients with ascites requiring pharmacologic intervention (e.g. diuretics) and stable for ≥2 months on low doses of diuretics (spironolactone 100 mg/d or equivalent) for ascites are eligible. Of note, diuretics for other indications such as congestive heart failure are not considered in this regard.

  9. Previous radiotherapy for HCC
  10. Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.
  11. Significant cardiovascular disease, such as cardiac disease (New York Heart Association Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, as well as unstable arrhythmias (note: beta blockers or digoxin are permitted), unstable angina, new-onset angina (begun within the last 3 months).
  12. Uncontrolled hypertension defined by a systolic blood pressure (BP) ≥150 mmHg or diastolic blood pressure (BP) ≥100 mmHg, with or without antihypertensive medication. Patients with initial blood pressure (BP) elevations are eligible if initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria.
  13. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.
  14. History of or current pheochromocytoma.
  15. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism ≤6 months prior to randomization.
  16. With regards to eligibility for adequate TACE, patients presenting with either of the following conditions are excluded:

    • Past history of bilioenteric anastomosis or biliary procedure (e.g., endoscopic papillotomy or biliary stenting) or patients with aerobilia
    • Central biliary obstruction (right or left intrahepatic duct, common hepatic duct, common bile duct)
    • Celiac occlusion
  17. Ongoing infection > grade 2 NCI-CTCAE version 5.0.
  18. Patients with seizure disorder requiring medication.
  19. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  20. Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization.
  21. Non-healing wound, ulcer, or bone fracture.
  22. Renal failure requiring hemo- or peritoneal dialysis.
  23. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  24. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation including a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein; known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.
  25. Positive test for human immunodeficiency virus (HIV)
  26. Active tuberculosis
  27. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  28. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan Note: History of radiation pneumonitis within the radiation field (fibrosis) is permitted.
  29. Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
  30. Any malabsorption conditions.
  31. Pregnant or nursing women
  32. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  33. Active or history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.

    Note: History of autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone, or controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible based on consultation with the sponsor's medical monitor. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

    • Rash must cover < 10% of body surface area
    • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
    • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
  34. Pleural effusion or (thoracal/abdominal) ascites causing respiratory compromise (≥CTCAE version 4.0 Grade 2 dyspnea).
  35. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:

    • Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
    • Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  36. Use of any herbal remedies known to interfere with the liver or other major organ functions. Patients must notify the investigator of all herbal remedies used during the study.
  37. Administration of a live, attenuated vaccine within four weeks prior to start of enrollment, or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab.
  38. History of malignancy other than HCC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g. 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
  39. Receipt of an investigational drug within 28 days prior to initiation of study drug
  40. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peter Galle, Prof. Dr. 0049 6131 177275 peter.galle@unimedizin-mainz.de
Contact: Johanna Riedel, Dr. 0049 697 601 4635 riedel.johanna@ikf-khnw.de
Listed Location Countries  ICMJE Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04803994
Other Study ID Numbers  ICMJE ABC-HCC
2020-004210-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Current Responsible Party Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Salah Eddin Al-Batran, Prof. Dr. Institut für Klinische Krebsforschung IKF GmbH, Frankfurt, Germany
Principal Investigator: Peter Galle, Prof. Dr. Universitätsmedizin Mainz, Germany
Principal Investigator: Jordi Bruix, Prof. Dr. Barcelona Clinic Liver Cancer, Universitat de Barcelona, Spain
PRS Account Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP