NCT07018947

Study to Evaluate the Efficacy and Safety of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in HCC

A Phase II, Randomized, Open-label, National, Multicenter Study Evaluating the Efficacy and Safety of the Combination of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in Hepatocellular Carcinoma (ASPIRE)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy and safety of the combination of Atezolizumab and Bevacizumab as neoadjuvant plus adjuvant treatment in Hepatocellular Carcinoma.

Conditions

• Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab and Bevacizumab	Participants will receive up to three 3 atezolizumab doses (days 10, 31, 52) and 2 bevacizumab dose (days 10 and 31) until surgery or unacceptable toxicity, whichever occurs first (neoadjuvant therapy). The adjuvant therapy with Atezo + Bev will start between 4 and 12 weeks after the resection date, once the participant has fully recovered from the surgery. Participants will receive up to 12 months or 17 cycles of treatment, whichever occurs first, or until disease recurrence or unacceptable toxicity.

Timeline

• Start date: 2025-11-01
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

13 sites across 1 country: Spain