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

PHASE2RecruitingINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

February 29, 2028

Study Completion Date

February 28, 2031

Conditions
Hepatocellular Carcinoma
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.

Trial Locations (19)

Unknown

RECRUITING

CHU Amiens, Amiens

RECRUITING

CHU d'Angers, Angers

RECRUITING

Hôpital Jean Verdier, Bondy

RECRUITING

Hôpital Beaujon, Clichy

RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

CHU Dijon, Dijon

RECRUITING

CHU de Grenoble, Grenoble

NOT_YET_RECRUITING

CHU de Lille, Lille

RECRUITING

Hôpital Saint Joseph, Marseille

RECRUITING

CHU de Montpellier, Montpellier

RECRUITING

CHRU de Nancy, Nancy

RECRUITING

CHU de Nantes, Nantes

NOT_YET_RECRUITING

CHU de Nice, Nice

RECRUITING

CHU Nîmes, Nîmes

RECRUITING

Hôpital Cochin, Paris

RECRUITING

CH Perpignan, Perpignan

RECRUITING

CHU de Poitiers, Poitiers

RECRUITING

CHU de Rennes, Rennes

RECRUITING

Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER