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

NCT07543510 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-22

No results posted yet for this study

Summary

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 improved anti-tumor activity with manageable safety in patients with unresectable HCC.

Conditions

Interventions

DRUG

TACE-HAIC + Atezolizumab + Low-dose Bevacizumab

Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen, administered via hepatic artery catheter. The HAIC regimen consists of oxaliplatin 85 mg/m² by arterial infusion over 2 hours on Day 1, followed by leucovorin 400 mg/m² by arterial infusion over 1 hour on Day 1, then fluorouracil 400 mg/m² bolus infusion and 2400 mg/m² continuous infusion over 24 hours. Subsequently, participants receive intravenous atezolizumab (1200 mg fixed dose, every 3 weeks) and low-dose bevacizumab (7.5 mg/kg, every 3 weeks). Each treatment cycle is 21 days. Treatment continues until disease progression according to RECIST v1.1, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria.

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-08-31
Completion
2029-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543510 on ClinicalTrials.gov