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

NCT07281664 | Not Yet Recruiting DMC

• 1 other identifier: II2025-380-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma; Transarterial Chemoembolization

Keywords

Hepatocellular Carcinoma; Transarterial chemoembolization; Bevacizumab; Atezolizumab

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Time from randomization to death from any cause.

  2 years

Secondary Outcomes (1)

• Progression free survival (PFS)

  2 years

Other Outcomes (1)

• Objective response rate (ORR)

  2 years

Study Arms (1)

TACE + LDBev + Atezo

EXPERIMENTAL

Participants in this single-arm study will receive a combination treatment consisting of transarterial chemoembolization (TACE) followed by systemic therapy with low-dose bevacizumab and atezolizumab. TACE will be performed as the locoregional therapy to control intrahepatic tumors, after which bevacizumab and atezolizumab will be administered to inhibit angiogenesis and enhance antitumor immune activity. All participants will be treated according to the study protocol to evaluate the safety and clinical activity of this integrated therapeutic approach for unresectable hepatocellular carcinoma.

Procedure: Transarterial chemoembolization (TACE); Drug: bevacizumab and atezolizumab

Interventions

Transarterial chemoembolization (TACE) PROCEDURE

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.

TACE + LDBev + Atezo

bevacizumab and atezolizumab DRUG

Low dose bevacizumab and atezolizumab

TACE + LDBev + Atezo

Eligibility Criteria

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

You may qualify if:

• Age between18 and 75 years;
• Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
• Child-Pugh class A;
• Eastern Cooperative Group performance status (ECOG) score of 0-1;
• No prior systemic therapy for HCC.
• Adequate hematologic and end-organ function;
• At least one measurable intrahepatic target lesion.

You may not qualify if:

• Diffuse HCC;
• Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
• Evidence of extrahepatic spread (EHS);
• Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
• Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \>CTCAE grade 3 within 4 weeks prior to randomization;
• Active or history of autoimmune disease or immune deficiency;
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding;
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;
• Evidence of bleeding diathesis or significant coagulopathy;
• Pregnant or breastfeeding females;
• Significant cardiovascular disease;
• Severe infection, such as active tuberculosis;
• Serious medical comorbidities;
• History of organ or cells transplantation;
• History of other uncurable malignancies.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; atezolizumab

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

Study Officials

• Mingsheng Huang, M.D. & Ph.D

  Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingsheng Huang, M.D. & Ph.D

CONTACT

+862085253416; huangmsh@mail.sysu.edu.cn

Chenghao Zhao

CONTACT

M.D.; zhaochh8@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of Department of Interventional Radiology

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share