RecruitingPhase 2NCT04727307

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

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


Sponsor

University Hospital, Montpellier

Enrollment

202 participants

Start Date

Feb 23, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving immunotherapy before and after radiofrequency ablation (a procedure that destroys small liver tumors with heat) improves outcomes for patients with early-stage liver cancer (hepatocellular carcinoma, or HCC). It uses two immunotherapy drugs — atezolizumab and bevacizumab. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of liver cancer (HCC) - You have 1 to 3 small liver tumors, each under 3 cm, suitable for ablation - Your liver function is adequate (Child-Pugh Class A) - Your overall health is good (ECOG performance status 0 or 1) - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if:** - You have cancer that has spread outside the liver - You have had a prior liver transplant or prior HCC surgery showing blood vessel invasion - You have an active autoimmune disease requiring systemic treatment - You are on blood thinners or high-dose aspirin - You have uncontrolled hepatitis B (viral load over 500 IU/mL) - You are pregnant or breastfeeding - You have a history of HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab (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.

PROCEDUREPercutaneous Radiofrequency

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

DRUGBevacizumab (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.

DRUGAtezolizumab (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

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NCT04727307


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