Actively Recruiting
Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial
Led by University Hospital, Montpellier · Updated on 2025-09-30
202
Participants Needed
19
Research Sites
518 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC. In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant/neoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC. Local ablation of HCC is therefore an "ideal" setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.
CONDITIONS
Official Title
Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Diagnosis of hepatocellular carcinoma based on imaging according to EASL guidelines
- Eligible for ablation with 1 to 3 HCC nodules smaller than 3 cm
- At least one measurable tumor lesion by MRI using modified RECIST criteria
- Liver function status Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate bone marrow, liver, and kidney function as shown by specified lab tests (hemoglobin > 8.5 g/dL, neutrophils ≥ 1500/mm3, platelets ≥ 50,000/mm3, total bilirubin ≤ 2 mg/dL, ALT and AST ≤ 5 times upper limit normal, serum creatinine ≤ 1.5 times upper limit normal, lipase ≤ 2 times upper limit normal, prothrombin time > 50%, GFR ≥ 35 mL/min/1.73 m2)
- Life expectancy of at least 3 months
- Agreement to use effective contraception if of childbearing potential
- Affiliated with a Social Security System
You will not qualify if you...
- Contraindications to ablation, Atezolizumab, or Bevacizumab
- Contraindications to intravenous contrast agents (gadolinium or iodinated)
- Contraindications to MRI
- Prior liver transplantation
- Liver function classified as Child-Pugh B or C
- Mixed liver cancer histology if biopsy available
- Recent therapeutic use of full-dose anticoagulants or thrombolytics within 10 days prior to study
- Recent use of high-dose aspirin (> 325 mg/day) or certain antiplatelet medications within 10 days prior to study
- Active or history of certain autoimmune diseases or immune deficiencies, with specific exceptions
- Recent or planned systemic immunosuppressive treatment within 2 weeks prior to study, with exceptions
- Portal vein invasion seen on baseline imaging
- Prior chemoembolization or radioembolization treatments
- Presence of extra-hepatic metastases except limited small lung nodules or lymph nodes
- Previous surgery with vascular invasion confirmed
- Prior systemic treatment for HCC targeting immune checkpoints
- Uncontrolled Hepatitis B infection with viral load above 500 IU/mL
- Untreated or high-risk esophageal or gastric varices unless treated
- Past or current cancers other than HCC except certain early-stage cancers treated over 3 years ago
- Known or symptomatic meningeal tumors
- Severe hypertension grade 3 or above
- Pheochromocytoma
- Active infections requiring treatment
- Significant bleeding within 30 days before enrollment
- Recent arterial or venous blood clots within 6 months
- Conditions affecting safety or compliance with study
- Known HIV infection
- Seizure disorder needing medication
- Non-healing wounds or fractures
- Breastfeeding or pregnancy
- Legal incapacity or custody
- Deprivation of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CHU d'Angers
Angers, France
Actively Recruiting
3
Hôpital Jean Verdier
Bondy, France
Actively Recruiting
4
Hôpital Beaujon
Clichy, France
Actively Recruiting
5
Centre Georges François Leclerc
Dijon, France
Actively Recruiting
6
CHU Dijon
Dijon, France
Actively Recruiting
7
CHU de Grenoble
Grenoble, France
Actively Recruiting
8
CHU de Lille
Lille, France
Not Yet Recruiting
9
Hôpital Saint Joseph
Marseille, France
Actively Recruiting
10
CHU de Montpellier
Montpellier, France
Actively Recruiting
11
CHRU de Nancy
Nancy, France
Actively Recruiting
12
CHU de Nantes
Nantes, France
Actively Recruiting
13
CHU de Nice
Nice, France
Not Yet Recruiting
14
CHU Nîmes
Nîmes, France
Actively Recruiting
15
Hôpital Cochin
Paris, France
Actively Recruiting
16
CH Perpignan
Perpignan, France
Actively Recruiting
17
CHU de Poitiers
Poitiers, France
Actively Recruiting
18
CHU de Rennes
Rennes, France
Actively Recruiting
19
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
W
Wendy RENIER, PhD
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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