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

Sponsor
Fundacion Clinic per a la Recerca Biomédica
Study ID
NCT07018947
Phase
PHASE2
Status
Recruiting
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Conditions

  • Resectable Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab and Bevacizumab — DRUG
    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.

Study Details

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

Key Dates

First listed
Jun 13, 2025
Start date
Jun 2, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab and Bevacizumab
    Participants in the atezolizumab plus bevacizumab (Atezo + Bev) arm 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.
  • No Intervention: Survillance
    In Arm Survillance, participants will receive standard of care with no neoadjuvant and adjuvant treatment, undergo surgical resection.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: From randomization to the first documented recurrence of disease or death from any cause, whichever occurs first, assessed up to 5 years. ]

Central Contacts

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