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Recruiting NCT07239245

Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo

Phase II Interventional Resectable Hepatocellular Carcinoma With High Risk of Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atezolizumab, Bevacizumab, Transarterial chemoembolization (TACE).
Who it may be relevant to
Registry conditions: Resectable Hepatocellular Carcinoma With High Risk of Recurrence. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Atezolizumab
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Drug Bevacizumab
    Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
  • Procedure Transarterial chemoembolization (TACE)
    TACE will be performed by clinical demand.

Primary outcome measures

  • Pathologic Complete Response (pCR) Rate [Time frame: At the time of surgery]
Secondary outcome measures (5)
  • Major Pathologic Response (MPR) Rate [Time frame: At the time of surgery]
  • Relapse-Free Survival (RFS) [Time frame: Surgery to the first documented recurrence of disease (up to approximately 2 years)]
  • Event-Free Survival (EFS) [Time frame: Enrollment up to approximately 2 years]
  • Overall Survival (OS) [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 [Time frame: From the start of treatment to 30 days after surgery]

Eligibility criteria

Inclusion criteria

  • Signed Informed Consent Form available
  • Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
  • Diagnosis of HCC confirmed by histology
  • Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size >5 cm, tumor number >3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).

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)

  • Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
  • Child-Pugh A
  • ECOG PS 0～1
  • No prior locoregional or systemic treatment for HCC
  • Negative HIV test at screening

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
  • Clinically diagnosed hepatic encephalopathy in the last 6 months
  • Autoimmune hepatitis (requiring liver puncture)
  • History of organ transplantation
  • Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  • Known severe allergic reaction to contrast (e.g., anaphylaxis).
  • Pregnancy or lactating women.
  • Inability to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Cancer Hospital Chinese Academy of Medical Science — Beijing
  • Henan Cancer Hospital — Zhengzhou
  • The First Hospital of China Medical University — Shenyang
  • Shanxi Cancer Hospital — Taiyuan

Identifiers

NCT: NCT07239245 · NCC5353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗