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RECRUITING
NCT04727307
PHASE2

Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Official title: Neoadjuvant Atezolizumab and Adjuvant Atezolizumab + Bevacizumab in Combination With Percutaneous Radiofrequency Ablation of Small HCC: a Multicenter Randomized Phase II Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2021-02-23

Completion Date

2031-02

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab (neoadjuvant)

Atezolizumab 1200mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks) in neoadjuvant, for 2 cycles. The initial dose will be delivered over 60 (± 15) minutes and if tolerated subsequent infusions may be given over 30 (± 10) minutes.

PROCEDURE

Percutaneous Radiofrequency

Any RFA system (uni/multi-needle, monopolar or multi-bi-polar) is allowed. Microwave ablation or irreversible electroporation is not allowed.

DRUG

Bevacizumab (adjuvant)

Bevacizumab 15 mg/kg will be delivered as an IV infusion on Day 1 of each 3 week cycle in adjuvant, for 15 cycles maximum. The initial dose will be delivered over 90 minutes (±15 minutes) and if tolerated subsequent infusions may be given over 60 (± 10) minutes then over 30 (± 10) minutes.

DRUG

Atezolizumab (adjuvant)

Atezolizumab 1200 mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks) in adjuvant, for 15 cycles maximum. The dose will be delivered over 30 (± 10) minutes.

Locations (19)

CHU Amiens

Amiens, France

CHU d'Angers

Angers, France

Hôpital Jean Verdier

Bondy, France

Hôpital Beaujon

Clichy, France

Centre Georges François Leclerc

Dijon, France

CHU Dijon

Dijon, France

CHU de Grenoble

Grenoble, France

CHU de Lille

Lille, France

Hôpital Saint Joseph

Marseille, France

CHU de Montpellier

Montpellier, France

CHRU de Nancy

Nancy, France

CHU de Nantes

Nantes, France

CHU de Nice

Nice, France

CHU Nîmes

Nîmes, France

Hôpital Cochin

Paris, France

CH Perpignan

Perpignan, France

CHU de Poitiers

Poitiers, France

CHU de Rennes

Rennes, France

Institut Gustave Roussy

Villejuif, France