This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
TACE will be performed by clinical demand.
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGPathologic Complete Response (pCR) Rate
pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.
Time frame: At the time of surgery
Major Pathologic Response (MPR) Rate
MPR rate is defined as the proportion of participants with =\<30% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
Time frame: At the time of surgery
Relapse-Free Survival (RFS)
RFS is defined as the time from surgery to the first documented recurrence of disease (intrahepatic or extrahepatic) according to EASL and/or RECIST v1.1, or death from any cause.
Time frame: Surgery to the first documented recurrence of disease (up to approximately 2 years)
Event-Free Survival (EFS)
EFS is defined as the time from enrollment to any of the following events (whichever occurs first): disease progression that precludes surgery, as assessed by the investigator according RECIST v1.1; local regional, or distant disease recurrence as measured by EASL and/or RECIST v1.1; or death from any cause.
Time frame: Enrollment up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: Enrollment to death from any cause (up to approximately 5 years)
Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0
Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.
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Shanxi Cancer Hospital
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGTime frame: From the start of treatment to 30 days after surgery