AzTrials
AzTrials

Hepatocellular CarcinomaPhase 3NCT04803994

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

A Phase 3 study testing Atezolizumab, Bevacizumab and TACE in people with Hepatocellular Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 72 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Atezolizumab, Bevacizumab and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
434 participants
Where
72 sitesin 6 countries
Study dates
6 Jul 2021to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form available
  • Patients* ≥ 18 years of age at time of signing Informed Consent Form
  • Confirmed hepatocellular carcinoma diagnosis based on histopathological findings from tumor tissue or typical diagnostic imaging on dynamic CT or MRI according to AASLD criteria.
  • Intermediate stage HCC as defined by the following criteria:
  • Disease not amenable to curative surgery, liver transplantation or curative ablation BUT disease amenable to TACE at enrollment as judged by the investigator.
  • No massive multinodular pattern preventing adequate TACE
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  • No tumor of a diffuse infiltrative HCC type (hypovascular infiltrative tumors with ill-defined borders)
  • Patent portal vein flow
  • No main portal vein invasion/thrombosis on baseline/eligibility imaging. Patients with minimal invasion, (Vp1 and Vp2) may be eligible if no exclusion criteria are violated.
  • No extrahepatic disease Note: Patients with HCC beyond Milan criteria who enter a downstaging protocol may be recruited into the trial if they do not present any exclusion criteria.
  • Patients with recurrence after resection/ablation or after previous TACE are eligible, if they - according to the investigator - have an indication for (additional) TACE
  • Child-Pugh score class A or B7 without ascites requiring more than 100 mg of spironolactone/day (see exclusion criteria) at enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at enrollment.
  • Adequate organ and bone marrow function
  • Life expectancy of ≥ 3 months
  • The following laboratory values obtained less than or equal to 7 days prior to randomization.
  • Total bilirubin ≤ 3.0 x the upper limit of normal (ULN)
  • Urine dipstick for proteinuria ≤ 2+ (within 7 days prior to randomization) 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
  • The following other laboratory values measured within 7 days prior to randomization are either normal or if abnormal do not represent a medical contraindication for TACE and atezolizumab/bevacizumab as judged by the investigator: Platelet count, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine, INR or aPTT, alkaline phosphatase, neutrophil count (ANC), and serum albumin.
  • Negative serum pregnancy test done lesser than or equal to 7 days prior to randomization, for females of childbearing potential only.
  • 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 randomization.
  • Absence of other severe comorbidities
  • Resolution of any acute, clinically significant treatment-related adverse events from prior therapy/procedure to Grade ≤ 1 prior to randomization, with the exception of alopecia.
  • For patients with active hepatitis B virus (HBV):
  • HBV DNA ≤ 2000 IU/mL obtained within 28 days prior to randomization, AND
  • Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue treatment for the length of the study.
  • 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.
  • For HBV and HCV co-infection refer to exclusion criterion # 11.
  • 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.
  • 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.
  • There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.

Who cannot join

  • 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC (only if proven by biopsy).
  • Previous treatment with atezolizumab or bevacizumab.
  • 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.
  • Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control.
  • 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.
  • 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.
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  • 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).
  • Uncontrolled hypertension defined by a systolic blood pressure (BP) ≥ 150 mmHg or diastolic blood pressure (BP) ≥ 100 mmHg, with or without antihypertensive medication. Prior history of hypertensive crisis or hypertensive encephalopathy. Patients with initial blood pressure (BP) elevations are eligible if initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria.
  • Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose (prophylactic anticoagulation permitted, e.g. new oral anticoagulants [apixaban, dabigatran, rivaroxaban], LMW heparin, ASA up to 300 mg/qd).
  • Arterial or venous thrombotic or embolic events such as cerebro-vascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism ≤6 months prior to randomization.
  • 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
  • Any ongoing infection > grade 2 NCI-CTCAE version 5.0. Note on HIV, HBV, and HCV infection: also consider inclusion criteria #s 15, 16, and exclusion criterion # 18. Patients with co-infection for HBV and HCV are excluded, unless tested negative for HCV RNA by PCR.
  • Patients with seizure disorder requiring medication.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE grade 3 within 4 weeks prior to randomization.
  • Non-healing wound, ulcer, or bone fracture.
  • Renal failure requiring hemo- or peritoneal dialysis.
  • 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.
  • Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), with the following exception: patients with a positive HIV test at screening are eligible, provided they are stable on anti-retroviral therapy, have a CD4 count > 200 cells/µL, and have an undetectable viral load.
  • Active tuberculosis
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • 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.
  • Persistent proteinuria of CTCAE Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
  • Pregnant or nursing women
  • 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.
  • 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.
  • 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.
  • 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.
  • 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, 6 months after the last dose of bevacizumab, or 1 month after the last TACE procedure.
  • 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. Other similar cases can be considered after discussion with lead investigators and sponsor.
  • Receipt of an investigational drug within 28 days prior to initiation of study drug
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent or patients with substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

Trial locations and contacts

72 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Peter Galle, Prof. Dr. contact

0049 6131 177275

peter.galle@unimedizin-mainz.de

Johanna Riedel, Dr. contact

0049 697 601 4635

riedel.johanna@ikf-khnw.de

72 sites in 6 countries

Germany26 sites, 26 recruiting

  • University Hospital RWTH Aachen

    Aachen, 52074

    Recruiting

  • Klinikum St. Marien Amberg

    Amberg, 92224

    Recruiting

  • Vivantes Klinikum Neukölln

    Berlin, 12351

    Recruiting

  • Universitätsklinikum Bochum

    Bochum, 44892

    Recruiting

  • Uniklinik Köln

    Cologne, 50937

    Recruiting

  • Universitätsklinikum Dresden

    Dresden, 01307

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, 91054

    Recruiting

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

    Recruiting

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Klinikum Konstanz

    Konstanz, 78464

    Recruiting

  • Krankenhaus Maria-Hilf Krefeld

    Krefeld, 47805

    Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

    Recruiting

  • Universitätsmedizin Mainz

    Mainz, 55131

    Peter Galle, Prof. Dr., 00496131177275, peter.galle@unimedizin-mainz.de

    Peter Galle, Prof. Dr.

    Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167

    Recruiting

  • Universitätsklinikum Marburg

    Marburg, 35043

    Recruiting

  • Klinikum rechts der Isar München

    München, 81675

    Recruiting

  • Klinikum Mutterhaus Trier

    Trier, 54290

    Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

    Recruiting

  • Uniklinik Ulm

    Ulm, 89070

    Recruiting

  • St. Josefs Hospital Wiesbaden

    Wiesbaden, 65189

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, 97078

    Recruiting

Other trials in Germany

Spain15 sites, 15 recruiting

  • Hospital Universitario de Alicante

    Alicante, 03010

    Recruiting

  • Hospital Infanta Cristina

    Badajoz, 06080

    Recruiting

  • Hospital Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

    Recruiting

  • Barcelona Clinic Liver Cancer, Universitat de Bracelona

    Barcelona, 08036

    Jordi Bruix, Prof. Dr., jbruix@clinic.cat

    Recruiting

  • Hospital Puerta del Mar

    Cadiz, 11009

    Recruiting

  • Hospital de Jaen

    Jaén, 23007

    Recruiting

  • Hospital Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Fundación Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

    Recruiting

  • Hospital de Alcorcón

    Madrid, 28922

    Recruiting

  • Hospital de Málaga

    Málaga, 29010

    Recruiting

  • Hospital Marqués de Valdecilla

    Santander, 39008

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • Institut Sainte-Catherine

    Avignon, 84918

    Recruiting

  • Hôpital Jean-Verdier Avicenne

    Bobigny, 93000

    Recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Recruiting

  • CHU Clermont-Ferrand CHU Estaing

    Clermont-Ferrand, 63100

    Recruiting

  • Beaujon Hospital

    Clichy, 92110

    Recruiting

  • CHU Grenoble

    Grenoble, 38700

    Recruiting

  • Croix-Rousse Hopital

    Lyon, 69004

    Recruiting

  • Saint Joseph Hopital - Marseille

    Marseille, 13008

    Recruiting

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, 75013

    Recruiting

  • Centre Hépato-biliaire Paul Brousse

    Villejuif, 94800

    Recruiting

Other trials in France

Japan9 sites, 9 recruiting

  • Hokkaido University Hospital

    Hokkaido, 060-8648

    Recruiting

  • Kobe University Hospital

    Kobe, 650-0017

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Recruiting

  • Kindai University Hospital

    Osaka, 589-8511

    Recruiting

  • Saitama Medical University Hospital

    Saitama, 350-0451

    Recruiting

  • Fujita Health University Hospital

    Toyoake, 470-1192

    Recruiting

  • Yamaguchi University Hospital

    Ube, 755-0046

    Recruiting

Other trials in Japan

Austria6 sites, 6 recruiting

  • LKH - Univ. Klinikum Graz

    Graz, 8036

    Recruiting

  • Medzinische Universität Innsbruck

    Innsbruck, 6020

    Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

    Recruiting

  • Ordensklinikum Linz

    Linz, 4010

    Recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

    Recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Recruiting

Other trials in Austria

Italy6 sites, 6 recruiting

  • Policlinico S. Orsola Bologna

    Bologna, 40138

    Recruiting

  • Instituto Tumori della Romagna IRST IRCCS

    Meldola, 47014

    Recruiting

  • Policlinico di Milano

    Milan, 20122

    Recruiting

  • Instituto di Tumori

    Milan, 20133

    Recruiting

  • Università di Pisa (UNIPI)

    Pisa, 56124

    Recruiting

  • AOUI Verona

    Verona, 37126

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Read the 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.

Keywords
hepatocellular carcinoma, HCC, intermediate stage, atezolizumab, bevacizumab, TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)

  • TACEProcedure or surgery

    Also called transarterial chemoembolization

    Locoregional therapy will be performed as a standard-of-care procedure

Study groups in NCT04803994
Study groupRoleWhat they receive
Systemic therapy with atezolizumab + bevacizumabExperimentalPatients 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.
Receives: Drug: Atezolizumab; Drug: Bevacizumab
Locoregional therapy with TACEActive comparatorPatients 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.
Receives: Procedure: TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to failure of treatment strategy

    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.

    Measured: 48 months - assessed every 8 weeks (±7days)

Secondary outcomes (11)

  1. Overall survival (OS)

    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.

    Measured: 48 months

  2. Overall Survival Rate at 24 months (OS@24)

    The proportion of patients assigned to a treatment arm known to be alive at 24 months after randomization.

    Measured: 24 months

  3. Objective Response Rate (ORR)

    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.

    Measured: 48 months

  4. Time to Progression (TTP)

    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.

    Measured: 48 months

  5. Time to loss of systemic treatment options (TTSYS)

    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.

    Measured: 24 months

  6. Progression free survival (PFS)

    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.

    Measured: 48 months

  7. Duration of Treatment

    From start of treatment to permanent discontinuation of the treatment arms A and B.

    Measured: 24 months

  8. Duration of Response (DOR)

    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.

    Measured: 48 months

  9. Time to deterioration of liver function

    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

    Measured: 48 months

  10. Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0

    Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.

    Measured: 48 months

  11. QoL (EORTC QLQ-C30 and HCC18 sub-questionnaire)

    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.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start6 Jul 2021
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
434 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04803994
Sponsor's protocol ID
ABC-HCC
Other IDs
2020-004210-35, 2024-512953-26-00
Status last verified
Jan 2025
First submitted
15 Mar 2021
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Bevacizumab and TACE in people with Hepatocellular Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 72 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Germany, Spain, France, Japan, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter Galle, Prof. Dr. (0049 6131 177275, peter.galle@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to failure of treatment strategy (time frame: 48 months - assessed every 8 weeks (±7days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04803994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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