Actively Recruiting
Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab
Led by Ludwig-Maximilians - University of Munich · Updated on 2024-06-14
106
Participants Needed
7
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim of the study is to evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients.
CONDITIONS
Official Title
Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older at time of consent
- Able to follow study procedures as judged by investigator
- Life expectancy of at least 12 weeks
- Histologically confirmed hepatocellular carcinoma (HCC)
- Disease not suitable for curative surgery or local ablation but eligible for TACE
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Child-Pugh class A or B7 liver function
- Adequate blood counts and organ function
- Negative HIV test at screening
You will not qualify if you...
- Diffuse HCC or vascular invasion, extrahepatic spread, more than 7 lesions, or any lesion 7 cm or larger
- Clinically significant ascites
- Uncontrolled pleural or pericardial effusion
- History or presence of hepatic encephalopathy
- Co-infection with hepatitis B and C viruses
- Listed for liver transplantation
- Prior systemic therapy for HCC
- Previous treatment with TACE or selective internal radiation therapy
- Contraindications to TACE
- Major gastrointestinal bleeding within 4 weeks before randomization or untreated high-risk varices
- Active or past autoimmune disease or immune deficiency
- Prior allogeneic stem cell or solid organ transplant
- Lung diseases such as idiopathic pulmonary fibrosis or pneumonitis
- Active tuberculosis or severe infection requiring antibiotics within 4 weeks
- Significant cardiovascular disease or uncontrolled hypertension
- History of congenital long QT syndrome or prolonged QT interval
- Significant vascular disease needing surgery or recent arterial thrombosis
- History of abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Gastrointestinal obstruction or need for parenteral nutrition
- Intra-abdominal inflammatory conditions within 6 months
- Bleeding disorders or significant coagulopathy
- Any condition increasing risk from study treatment or affecting results
- Uncontrolled tumor-related pain unless on stable medication
- Severe wounds, ulcers, or untreated fractures
- History of other cancers unless disease-free for 5 years or adequately treated skin or certain other cancers
- Recent use of certain blood thinners or antiplatelet drugs
- Recent use of full dose anticoagulants or thrombolytics
- Chronic daily use of NSAIDs (occasional use allowed)
- Recent live attenuated vaccine or planned need during treatment
- Prior treatment with certain immune therapies
- Known allergy to study drugs or excipients
- Recent use of immunostimulatory or immunosuppressive medications with exceptions
- Recent major surgery or abdominal interventions
- Recent minor surgery within 3 days before first drug dose
- Pregnant or breastfeeding women
- Participation in another clinical trial or experimental treatment recently
- Legal or administrative institutionalization
- Close relatives of the investigator or dependent on them
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Bonn
Bonn, Germany
Actively Recruiting
2
University Hospital Cologne
Cologne, Germany, 50931
Actively Recruiting
3
Hospital of the University of Munich
Munich, Germany, 81377
Actively Recruiting
4
Klinikum Rechts der Isar of the Technical University Munich
Munich, Germany, 81675
Actively Recruiting
5
University Hospital Regensburg
Regensburg, Germany, 93053
Actively Recruiting
6
University Hospital Tübingen
Tübingen, Germany, 72076
Actively Recruiting
7
Würzburg University Hospital
Würzburg, Germany
Actively Recruiting
Research Team
E
Enrico De Toni, MD
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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