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

NCT07239245 | Recruiting Phase 2

• 1 other identifier: NCC5353
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Resectable Hepatocellular Carcinoma With High Risk of Recurrence

Keywords

Hepatocellular Carcinoma; Neoadjuvant therapy; TACE; Atezolizumab

Outcome Measures

Primary Outcomes (1)

• Pathologic 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.

  At the time of surgery

Secondary Outcomes (5)

• Major Pathologic Response (MPR) Rate

  At the time of surgery

• Relapse-Free Survival (RFS)

  Surgery to the first documented recurrence of disease (up to approximately 2 years)

• Event-Free Survival (EFS)

  Enrollment up to approximately 2 years

• Overall Survival (OS)

  Enrollment to death from any cause (up to approximately 5 years)

• Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0

  From the start of treatment to 30 days after surgery

Study Arms (1)

Atezolizumab + Bevacizumab + TACE

EXPERIMENTAL

Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.

Drug: Atezolizumab; Drug: Bevacizumab; Procedure: Transarterial chemoembolization (TACE)

Interventions

Atezolizumab DRUG

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

Atezolizumab + Bevacizumab + TACE

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.

Atezolizumab + Bevacizumab + TACE

Transarterial chemoembolization (TACE) PROCEDURE

TACE will be performed by clinical demand.

Atezolizumab + Bevacizumab + TACE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xinyu Bi

CONTACT

+86 (010)87787100; beexy1971@163.com

Xiaowu Zhang

CONTACT

+86 (010)87788502; zhangxiaowu767@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)