NCT07281664

Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Transarterial Chemoembolization Combined With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase II, Single-Arm Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth. All participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.

Detailed description

Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, when surgical treatment is no longer possible. Transarterial chemoembolization (TACE) is widely used for locoregional control, but many patients eventually experience tumor progression due to treatment-related hypoxia and activation of pro-angiogenic pathways. Combining TACE with systemic therapies that block angiogenesis and enhance antitumor immunity may help overcome these limitations. Bevacizumab, an anti-VEGF antibody, reduces tumor angiogenesis and may counteract the surge in VEGF that occurs after TACE. Atezolizumab, an immune checkpoint inhibitor, strengthens the immune response against cancer cells. Using low-dose bevacizumab together with atezolizumab may help maximize immunotherapy benefit while minimizing toxicity, especially when administered after TACE. This single-arm Phase II study is designed to investigate whether integrating TACE with low-dose bevacizumab and atezolizumab as first-line treatment can improve clinical outcomes in patients with unresectable HCC. The study will evaluate tumor control, treatment duration, and safety in real-world clinical settings. The findings may provide evidence to support a multimodal treatment strategy that targets both the tumor vasculature and the immune microenvironment, potentially offering a more effective option for patients with advanced liver cancer.

Conditions

• Hepatocellular Carcinoma
• Transarterial Chemoembolization

Interventions

Type	Name	Description
PROCEDURE	Transarterial chemoembolization (TACE)	The intervention consisted of TACE combined with low-dose bevacizumab and atezolizumab. TACE was performed within 30 days before or after systemic therapy. The choice between conventional TACE and DEB-TACE was determined by interventional radiologists, as both techniques show comparable efficacy. For DEB-TACE, epirubicin-loaded microspheres were used; for conventional TACE, an epirubicin-lipiodol emulsion was prepared. In all cases, the tumor-feeding artery was super-selectively catheterized, and embolization was performed to complete arterial stasis using gelatin sponge particles. Following TACE-induced ischemic and cytotoxic tumor control, patients received systemic therapy consisting of low-dose bevacizumab to attenuate post-TACE angiogenic rebound and atezolizumab to enhance antitumor immune activation. This sequential combination of locoregional therapy and dual-agent systemic therapy constitutes a distinct intervention compared with standard TACE or systemic therapy alone.
DRUG	bevacizumab and atezolizumab	Low dose bevacizumab and atezolizumab

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-12-15
• Last updated: 2025-12-15