Actively Recruiting
The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2025-01-07
434
Participants Needed
72
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form is available
- Age 18 years or older at time of consent
- Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging
- Intermediate-stage liver cancer suitable for TACE but not curative surgery or ablation
- No massive multinodular tumors or diffuse infiltrative HCC
- Patent portal vein flow without main portal vein invasion (minimal invasion Vp1 or Vp2 allowed)
- No cancer spread outside the liver
- Eligible if recurrence after prior resection, ablation, or TACE with indication for additional TACE
- Child-Pugh class A or B7 liver function without significant ascites
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function
- Life expectancy of at least 3 months
- Total bilirubin less than or equal to 3 times the upper limit of normal
- Urine protein less than or equal to 2+ on dipstick; if 2+ must have less than 1 g protein in 24 hours
- Other labs within normal limits or acceptable by investigator judgment
- Negative pregnancy test within 7 days prior to randomization for women of childbearing potential
- No untreated or high-risk esophageal varices; recent endoscopy and treatment per standards
- No severe other medical conditions
- Prior treatment side effects resolved to Grade 1 or less except alopecia
- For active hepatitis B: HBV DNA ≤ 2000 IU/mL and on antiviral treatment for at least 14 days
- For hepatitis C: positive antibody or RNA allowed but no antiviral therapy during trial
- Women of childbearing potential agree to effective contraception or abstinence during and after treatment
- Men agree to contraception or abstinence and to avoid sperm donation during and after treatment
You will not qualify if you...
- Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma-HCC confirmed by biopsy
- Prior treatment with atezolizumab, bevacizumab, PD1/PD-L1/CTLA-4 inhibitors, or cancer immunotherapy for HCC
- Clinically significant ascites requiring paracentesis
- Major surgery or significant trauma within 28 days before randomization
- Significant heart disease or recent heart attack or stroke within 3 months
- Uncontrolled high blood pressure
- Recent use of full-dose anticoagulants or thrombolytics (prophylactic doses allowed)
- Blood clots or embolic events within 6 months before randomization
- Past history of biliary tract surgeries or obstructions preventing TACE
- Active infections greater than grade 2 severity
- Seizure disorders requiring medication
- Prior bone marrow or organ transplant
- Recent severe bleeding or bleeding disorders
- Non-healing wounds or fractures
- Kidney failure requiring dialysis
- Known allergy to study drugs or components
- HIV positive unless stable on treatment with good immune status
- Active tuberculosis or lung disease including pneumonitis
- Persistent high-grade proteinuria
- Pregnant or nursing women
- Severe other illnesses that interfere with safety or study evaluation
- Active or history of autoimmune diseases unless stable and controlled
- Recent use of systemic immunosuppressive medications except certain low-dose or acute use
- Use of herbal remedies affecting major organs without informing investigator
- Recent live vaccine use or planned live vaccines during study period
- Recent other cancers within 3 years except low-risk types
- Use of investigational drugs within 28 days before study drug
- History of non-compliance or conditions interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
LKH - Univ. Klinikum Graz
Graz, Austria, 8036
Actively Recruiting
2
Medzinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
3
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
Actively Recruiting
4
Ordensklinikum Linz
Linz, Austria, 4010
Actively Recruiting
5
Universitätsklinikum St. Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
6
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
7
Institut Sainte-Catherine
Avignon, France, 84918
Actively Recruiting
8
Hôpital Jean-Verdier Avicenne
Bobigny, France, 93000
Actively Recruiting
9
CHU Bordeaux
Bordeaux, France, 33000
Actively Recruiting
10
CHU Clermont-Ferrand CHU Estaing
Clermont-Ferrand, France, 63100
Actively Recruiting
11
Beaujon Hospital
Clichy, France, 92110
Actively Recruiting
12
CHU Grenoble
Grenoble, France, 38700
Actively Recruiting
13
Croix-Rousse Hopital
Lyon, France, 69004
Actively Recruiting
14
Saint Joseph Hopital - Marseille
Marseille, France, 13008
Actively Recruiting
15
Hôpital Universitaire Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
16
Centre Hépato-biliaire Paul Brousse
Villejuif, France, 94800
Actively Recruiting
17
University Hospital RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
18
Klinikum St. Marien Amberg
Amberg, Germany, 92224
Actively Recruiting
19
Vivantes Klinikum Neukölln
Berlin, Germany, 12351
Actively Recruiting
20
Universitätsklinikum Bochum
Bochum, Germany, 44892
Actively Recruiting
21
Uniklinik Köln
Cologne, Germany, 50937
Actively Recruiting
22
Universitätsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
23
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
24
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
25
Klinikum Esslingen
Esslingen am Neckar, Germany, 73730
Actively Recruiting
26
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
27
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Actively Recruiting
28
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
29
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Actively Recruiting
30
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
31
Klinikum Konstanz
Konstanz, Germany, 78464
Actively Recruiting
32
Krankenhaus Maria-Hilf Krefeld
Krefeld, Germany, 47805
Actively Recruiting
33
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
34
Universitätsmedizin Mainz
Mainz, Germany, 55131
Actively Recruiting
35
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
36
Universitätsklinikum Marburg
Marburg, Germany, 35043
Actively Recruiting
37
Klinikum rechts der Isar München
München, Germany, 81675
Actively Recruiting
38
Klinikum Mutterhaus Trier
Trier, Germany, 54290
Actively Recruiting
39
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany, 54292
Actively Recruiting
40
Uniklinik Ulm
Ulm, Germany, 89070
Actively Recruiting
41
St. Josefs Hospital Wiesbaden
Wiesbaden, Germany, 65189
Actively Recruiting
42
Universitätsklinikum Würzburg
Würzburg, Germany, 97078
Actively Recruiting
43
Policlinico S. Orsola Bologna
Bologna, Italy, 40138
Actively Recruiting
44
Instituto Tumori della Romagna IRST IRCCS
Meldola, Italy, 47014
Actively Recruiting
45
Policlinico di Milano
Milan, Italy, 20122
Actively Recruiting
46
Instituto di Tumori
Milan, Italy, 20133
Actively Recruiting
47
Università di Pisa (UNIPI)
Pisa, Italy, 56124
Actively Recruiting
48
AOUI Verona
Verona, Italy, 37126
Actively Recruiting
49
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Actively Recruiting
50
Kobe University Hospital
Kobe, Japan, 650-0017
Actively Recruiting
51
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
52
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Actively Recruiting
53
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
Actively Recruiting
54
Kindai University Hospital
Osaka, Japan, 589-8511
Actively Recruiting
55
Saitama Medical University Hospital
Saitama, Japan, 350-0451
Actively Recruiting
56
Fujita Health University Hospital
Toyoake, Japan, 470-1192
Actively Recruiting
57
Yamaguchi University Hospital
Ube, Japan, 755-0046
Actively Recruiting
58
Hospital Universitario de Alicante
Alicante, Spain, 03010
Actively Recruiting
59
Hospital Infanta Cristina
Badajoz, Spain, 06080
Actively Recruiting
60
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
61
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
62
Barcelona Clinic Liver Cancer, Universitat de Bracelona
Barcelona, Spain, 08036
Actively Recruiting
63
Hospital Puerta del Mar
Cadiz, Spain, 11009
Actively Recruiting
64
Hospital de Jaen
Jaén, Spain, 23007
Actively Recruiting
65
Hospital Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
66
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
67
Hospital Fundación Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
68
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain, 28222
Actively Recruiting
69
Hospital de Alcorcón
Madrid, Spain, 28922
Actively Recruiting
70
Hospital de Málaga
Málaga, Spain, 29010
Actively Recruiting
71
Hospital Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
72
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
Research Team
P
Peter Galle, Prof. Dr.
CONTACT
J
Johanna Riedel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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