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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04803994

Studienbeginn:
Juli 2021

Letztes Update:
04.04.2024

Wirkstoff:
Atezolizumab, Bevacizumab

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Hepatocellular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
-

Studienleiter

Salah Eddin Al-Batran, Prof. Dr.
Study Director
Institut für Klinische Krebsforschung IKF GmbH, Frankfurt, Germany
Peter Galle, Prof. Dr.
Principal Investigator
Universitätsmedizin Mainz, Germany
Jordi Bruix, Prof. Dr.
Principal Investigator
Barcelona Clinic Liver Cancer, Universitat de Barcelona, Spain

Kontakt

Studienlocations
(3 von 68)

University Hospital RWTH Aachen
52074 Aachen
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Klinikum St. Marien Amberg
92224 Amberg
(Bayern)
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Vivantes Klinikum Neukölln
12351 Berlin
(Berlin)
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Universitätsklinikum Bochum
44892 Bochum
(Nordrhein-Westfalen)
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Universitätsklinikum Dresden
01307 Dresden
(Sachsen)
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Darmkrebszentrum Universitätsklinikum Düsseldorf
Moorenstraße 5
40225 Düsseldorf
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Hautkrebszentrum Universitätsklinikum Erlangen
Ulmenweg 18
91054 Erlangen
(Bayern)
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Interdisziplinäres Brustzentrum am Klinikum Esslingen
Hirschlandstraße 97
73730 Esslingen am Neckar
(Baden-Württemberg)
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Onkologisches Zentrum Krankenhaus Nordwest
Steinbacher Hohl 2-26
60488 Frankfurt am Main
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Universitätsklinikum Frankfurt
60590 Frankfurt
(Hessen)
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Universitätsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
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Brustzentrum der Universitätsmedizin Göttingen
Robert-Koch-Straße 40
37075 Göttingen
DeutschlandRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
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Klinikum Konstanz
78464 Konstanz
(Baden-Württemberg)
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Krankenhaus Maria-Hilf Krefeld
47805 Krefeld
(Nordrhein-Westfalen)
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Lungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandRekrutierend» Google-Maps
Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
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Darmkrebszentrum der Universitätsmedizin Mainz
Langenbeckstraße 1
55131 Mainz
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Peter Galle, Prof. Dr.
Phone: 00496131177275
E-Mail: peter.galle@unimedizin-mainz.de» Ansprechpartner anzeigen
Darmkrebszentrum Universitätsklinikum Mannheim
Theodor-Kutzer-Ufer 1 - 3
68167 Mannheim
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Universitätsklinikum Marburg
35043 Marburg
(Hessen)
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Klinikum rechts der Isar München
81675 München
(Bayern)
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Klinikum Mutterhaus Trier
54290 Trier
(Rheinland-Pfalz)
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Darmzentrum am Krankenhaus der Barmherzigen Brüder Trier
Nordallee 1
54292 Trier
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St. Josefs Hospital Wiesbaden
65189 Wiesbaden
(Hessen)
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Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Medzinische Universität Innsbruck
6020 Innsbruck
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Klinikum Klagenfurt am Wörthersee
9020 Klagenfurt
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Universitätsklinikum St. Pölten
3100 St. Pölten
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Hôpital Jean-Verdier Avicenne
93000 Bobigny
FranceRekrutierend» Google-Maps
CHU Clermont-Ferrand CHU Estaing
63100 Clermont-Ferrand
FranceRekrutierend» Google-Maps
Saint Joseph Hopital - Marseille
13008 Marseille
FranceRekrutierend» Google-Maps
Hôpital Universitaire Pitié Salpêtrière
75013 Paris
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Centre Hépato-biliaire Paul Brousse
94800 Villejuif
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Instituto Tumori della Romagna IRST IRCCS
47014 Meldola
ItalyRekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Hokkaido
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Kumamoto University Hospital
860-8556 Kumamoto
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University Hospital Kyoto Prefectural University of Medicine
602-8566 Kyoto
JapanRekrutierend» Google-Maps
Nagasaki University Hospital
852-8501 Nagasaki
JapanRekrutierend» Google-Maps
Saitama Medical University Hospital
350-0451 Saitama
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Fujita Health University Hospital
470-1192 Toyoake
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Hospital Universitario de Alicante
03010 Alicante
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Hospital Universitari Vall d'Hebrón
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramón y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Fundación Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro Majadahonda
28222 Madrid
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Hospital Marqués de Valdecilla
39008 Santander
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Hospital Universitario Virgen del Rocío
41013 Sevilla
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Signed Informed Consent Form available

2. Patients* ≥ 18 years of age at time of signing Informed Consent Form (for South Korea:

≥ 19 years and 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. 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

- 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.

5. Patients with recurrence after resection/ablation or after previous TACE (are

eligible, if they - according to the investigator - have an indication for

(additional) TACE

6. Child-Pugh score class A or B7 without ascites requiring more than 100 mg of

spironolactone/day (see exclusion criteria) at enrollment.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at enrollment.

8. Adequate organ and bone marrow function

9. Life expectancy of ≥ 3 months

10. 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.

11. Negative serum pregnancy test done lesser than or equal to 7 days prior to

randomization, for females of childbearing potential only.

12. 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.

13. Absence of other severe comorbidities

14. 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.

15. 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.

16. 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 # 17.

17. 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.

18. 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.

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC (only if

proven by biopsy).

2. Previous treatment with atezolizumab or bevacizumab.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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 300mg/qd).

9. 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.

10. 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

11. 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.

12. Patients with seizure disorder requiring medication.

13. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.

14. Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE

grade 3 within 4 weeks prior to randomization.

15. Non-healing wound, ulcer, or bone fracture.

16. Renal failure requiring hemo- or peritoneal dialysis.

17. 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.

18. 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.

19. Active tuberculosis

20. Interstitial lung disease with ongoing signs and symptoms at the time of informed

consent.

21. 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.

22. Persistent proteinuria of CTCAE Grade 3 or higher (> 3.5 g/24 hrs, measured by urine

protein: creatinine ratio on a random urine sample).

23. Pregnant or nursing women

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

29. 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.

30. Receipt of an investigational drug within 28 days prior to initiation of study drug

31. 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.

Studien-Rationale

Primary outcome:

1. 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.



Secondary outcome:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Duration of Treatment (Time Frame - 24 months):
From start of treatment to permanent discontinuation of the treatment arms A and B.

8. 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.

9. 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

10. 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.

11. 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.

Studien-Arme

  • 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.
  • 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.

Geprüfte Regime

  • Atezolizumab (Tecentriq):
    1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)
  • Bevacizumab (Avastin):
    15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)
  • TACE (transarterial chemoembolization):
    Locoregional therapy will be performed as a standard-of-care procedure

Quelle: ClinicalTrials.gov


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

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