Study to evaluate the efficacy and safety of the combination of Atezolizumab and Bevacizumab as neoadjuvant plus adjuvant treatment in Hepatocellular Carcinoma.
Signed Informed Consent Form.
Age ≥ 18 years at the time of signing Informed Consent Form.
Ability to fully comply with the protocol, in the investigator's judgment.
Diagnosis of HCC confirmed by histology.
Presence of extrahepatic disease or macrovascular invasion.
Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC.
History of hepatic encephalopathy if clinically significant within one year prior to screening.
CSPH in candidates for major resection (more than 3 segments).
Parallel
Atezolizumab and Bevacizumab
DrugParticipants 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.
Recurrence-free survival (RFS)
Measured by RFS, defined as the time from randomization to the first documented recurrence of disease according to RECIST v1.1 and mRECIST by the investigator's radiology team, or death from any cause (whichever occurs first).
Pathological response
Measured by MPR rate, defined as the proportion of participants with \> 70% necrosis of tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
Pathological response
Measured by complete pathological response (pCR) rate, defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.
Overall Survival (OS)
Measured by OS, defined as the time from randomization to death from any cause.
Efficacy of neoadjuvant with atezolizumab plus bevacizumab treatment combinations
Measured by Event-free survival (EFS), defined as time from randomization to predefined event, that may include disease progression/toxicity precluding surgery, relapse \[ both assessed according to RECIST v1.1 and mRECIST by the investigator's radiology team\] or death.
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