At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓HCC diagnosis by imaging per EASL guidelines
- ✓Eligible for ablation: all nodules <3cm, 1-3 nodules total
- ✓At least one uni-dimensional measurable lesion by MRI per modified RECIST
- ✕Contraindications to ablation, atezolizumab, or bevacizumab
- ✕Contraindication to contrast medium (gadolinium or iodinate)
- ✕Contraindication to MRI
- ✕Prior liver transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Neoadjuvant Atezolizumab and Adjuvant Atezolizumab + Bevacizumab in Combination With Percutaneous Radiofrequency Ablation of Small HCC: a Multicenter Randomized Phase II Trial
In Brief
A Phase 2 clinical trial evaluating Atezolizumab (neoadjuvant), Percutaneous Radiofrequency, and 2 other interventions for Hepatocellular Carcinoma. Active but no longer recruiting, targeting 202 participants across 19 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
Any RFA system (uni/multi-needle, monopolar or multi-bi-polar) is allowed. Microwave ablation or irreversible electroporation is not allowed.
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.
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.