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NCT Number: NCT07239245

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atezolizumab

Drug

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Bevacizumab

Drug

Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.

Transarterial chemoembolization (TACE)

Procedure

TACE will be performed by clinical demand.

Primary outcomes

  1. Pathologic Complete Response (pCR) Rate

    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.

Secondary outcomes

  1. Major Pathologic Response (MPR) Rate

    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.

  2. Relapse-Free Survival (RFS)

    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.

  3. Event-Free Survival (EFS)

    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.

  4. Overall Survival (OS)

    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.

  5. 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

    Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Acronym: ATTACH

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Nov 20, 2025
Registry last updated
Nov 25, 2025

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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