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

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT07543510
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TACE-HAIC + Atezolizumab + Low-dose Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TACE-HAIC + Atezolizumab + Low-dose Bevacizumab
    Participants with unresectable hepatocellular carcinoma who have not received prior systemic therapy will be enrolled into a single treatment cohort. All participants will receive transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) in combination with atezolizumab and low-dose bevacizumab as first-line treatment. Atezolizumab will be administered at a fixed dose of 1200 mg intravenously every 3 weeks, and bevacizumab will be administered at 7.5 mg/kg intravenously every 3 weeks. HAIC will be given using the FOLFOX regimen, and subsequent TACE will be performed as needed according to the patient's condition and investigator judgment. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Central Contacts

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