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Transcatheter arterial chemoembolization using CalliSpheres beads loaded with arsenic trioxide for unresectable large or huge hepatocellular carcinoma: a prospective study

  • Hepatobiliary-Pancreas
  • Published:
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Abstract

Objectives

To determine the safety and efficacy of transcatheter arterial chemoembolization with CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) in the first-line treatment of patients with large (5 cm ≤ maximum diameter < 10 cm) or huge (maximum diameter ≥ 10 cm) hepatocellular carcinoma (HCC).

Methods

Patients were randomly allocated to the CBATO-TACE group and the conventional transcatheter arterial chemoembolization (cTACE) group. The primary endpoint was progression-free survival (PFS). The secondary endpoint was overall survival (OS), treatment response, and treatment-related adverse events (TRAEs). The extrahepatic collateral arteries, liver function, and liver fibrosis after the first TACE were also evaluated.

Results

From September 2018 to September 2020, a total of 207 patients who underwent TACE were consecutively enrolled in this study. The median PFS was 9.5 months (range: 8.0 – 11.0) in the CBATO group, which was significantly longer than that in the cTACE group (6.0 months, range: 4.0–6.0) (p < 0.0001). Patients in the CBATO group had a median OS of 22 months (range: 20.0 – 27.0) compared with 16 months (range: 15.0 – 20.0) in the cTACE group (p = 0.0084). The most common TRAEs were fever (p = 0.043), and nausea and vomiting (p = 0.002), which were more observed in the cTACE group. In addition, the progressive disease time, pulmonary metastasis rate (p = 0.01), the mean number of extrahepatic collateral arteries (p = 0.01), and average number of TACE sessions (p = 0.025) were significantly decreased in the CBATO group.

Conclusions

CBATO-TACE achieved better therapeutic outcomes and similar safety profile compared to cTACE in large or huge HCC patients. Furthermore, CBATO-TACE was able to reduce extrahepatic collateral arteries production and extrahepatic lung metastasis.

Clinical relevance statement

Our study showed that CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) were effective and safe for the treatment of large and giant HCC. In addition, CBATO-TACE can reduce lateral hepatic branch artery formation and extrahepatic pulmonary metastasis, which provides a new treatment approach for unresectable HCC.

Key Points

• We compare long-term efficacy and safety of transcatheter arterial chemoembolization with CalliSpheres® beads loaded with arsenic trioxide (CBATO-TACE) and conventional transcatheter arterial chemoembolization (cTACE) in patients with large (5 cm ≤ maximum diameter < 10 cm) or huge HCC (maximum diameter ≥ 10 cm).

• Compared with cTACE, CBATO-TACE significantly improved therapeutic outcomes, overall survival, and progression-free survival in patients with large or huge HCC. The safety assessment suggested that CBATO-TACE is a safe treatment that improves the quality of life and has good treatment adherence.

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Abbreviations

AEs:

Adverse events

ALT:

Alanine transaminase

AST:

Aspartate transaminase

ATO:

Arsenic trioxide

BCr:

Blood creatinine

BUN:

Blood urea nitrogen

CBATO-TACE:

CalliSpheres® beads loaded with arsenic trioxide

CR:

Complete remission

cTACE:

Conventional transcatheter arterial chemoembolization

DCR:

Disease control rate

DEB-TACE:

Drug-eluting bead TACE

EHC:

Extrahepatic collateral

HCC:

Hepatocellular carcinoma

mRECIST:

Modified Response Evaluation Criteria in Solid Tumors

ORR:

Objective response rate

OS:

Overall survival

PFS:

Progression-free survival

RBC:

Red blood cell

WBC:

White blood cell

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Funding

This work was supported by the National Natural Science Foundation of China (No. U2004119), the National Natural Science Foundation of Henan Province (No. 202300410361), and the Beijing Medical Award Foundation (No. YXJL-2021–0072-0349).

Author information

Author notes

  1. Xuhua Duan and Hao Li contributed equally to this work.

Authors and Affiliations

  1. Department of Interventional Radiology, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People’s Republic of China

    Xuhua Duan, Hao Li, Pengfei Chen, Donglin Kuang, Huibin Lu, Zhuangjian Ren & Xinwei Han

  2. Department of Hepatobiliary Surgery, The First Affiliated Hospital, Zhengzhou University, No. 1, East Jian She Road, Zhengzhou, 450052, Henan Province, People’s Republic of China

    Tao Sun, Bingbing Qiao & Zhengjun Fan

Authors
  1. Xuhua Duan
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Corresponding authors

Correspondence to Zhuangjian Ren or Xinwei Han.

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Guarantor

The scientific guarantor of this publication is Xinwei Han.

Conflict of interest

The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

Statistics and biometry

One of the authors has significant statistical expertise.

Informed consent

Written informed consent was obtained from all patients in this study.

Ethical approval

This study was approved by the Ethics Committee of the First Affiliated Hospital of Zhengzhou University and registered in the Chinese Clinical Trial Registry (Registration Number: ChiCTR1800018418).

Study subjects or cohorts overlap

None.

Methodology

• Prospective

• Randomized controlled trial

• Performed at one institution

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Duan, X., Li, H., Chen, P. et al. Transcatheter arterial chemoembolization using CalliSpheres beads loaded with arsenic trioxide for unresectable large or huge hepatocellular carcinoma: a prospective study. Eur Radiol 34, 1258–1267 (2024). https://doi.org/10.1007/s00330-023-10097-1

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