Atezolizumab
DrugAtezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
NCT Number: NCT07239245
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Up to three tumors, with largest tumor >5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) and/or poor tumor differentiation (Grade 3 or 4)
Exclusion criteria
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.
Time frame: At the time of surgery
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
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: Surgery to the first documented recurrence of disease (up to approximately 2 years)
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: Enrollment up to approximately 2 years
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 to death from any cause (up to approximately 5 years)
OS is defined as the time from enrollment to death from any cause.
Time frame: From the start of treatment to 30 days after surgery
Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.
Contact information is provided by the study sponsor or research team.
Xiaowu Zhang
CONTACT
Xinyu Bi
CONTACT
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study
Acronym: ATTACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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