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Low-Dose Bevacizumab Atezolizumab TACE-HAIC for HCC

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Summary

This is a prospective, single-arm, Phase II clinical study (NCT07543510) evaluating the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy. The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1.

“The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1.”

NIH , verbatim from source
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This ClinicalTrials.gov registration describes a prospective, single-arm, Phase II clinical study evaluating a combination regimen of low-dose bevacizumab and atezolizumab with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) in approximately 38 patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy. The study aims to explore whether TACE-HAIC can improve objective response rates by increasing local chemotherapy exposure and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety. Clinical investigators conducting oncology or hepatocellular carcinoma research should be aware of this trial as it represents an investigational combination approach evaluating the synergy between locoregional therapy and systemic immunotherapy for advanced HCC.

Archived snapshot

Apr 23, 2026

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← ClinicalTrials.gov Studies

Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular Carcinoma

N/A NCT07543510 Kind: NA Apr 22, 2026

Abstract

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy.

Although atezolizumab plus bevacizumab has become a standard first-line treatment option for advanced HCC, the objective response rate remains limited. TACE-HAIC may improve tumor control by increasing local chemotherapy exposure, promoting tumor antigen release, and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. In this study, patients will receive TACE-HAIC in combination with atezolizumab and low-dose bevacizumab, followed by maintenance treatment with atezolizumab plus low-dose bevacizumab until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.

The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints include ORR by mRECIST, disease control rate, duration of response, progression-free survival, time to progression, overall survival, and safety. This study aims to explore whether this combination strategy can provide improv...

Conditions: Hepatocellular Carcinoma, Atezolizumab Plus Bevacizumab, Transarterial Chemoembolization

Interventions: TACE-HAIC + Atezolizumab + Low-dose Bevacizumab

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Named provisions

Objective response rate (ORR)

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical research Pharmaceutical trials
Threshold
Approximately 38 patients
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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