Multicenter, prospective clinical trial for balloon-occluded alternative infusion of cisplatin solution and fragmented gelatin particles of transarterial chemoembolization for hepatocellular carcinoma beyond up-to-seven criteria

Sci Rep. 2025 May 13;15(1):16502. doi: 10.1038/s41598-025-01444-x.

Abstract

Transarterial chemoembolization (TACE) is considered unsuitable for hepatocellular carcinoma (HCC) that exceeds up-to-7 criteria. Balloon-occluded alternative infusion of cisplatin solution and gelatin particles of transarterial chemoembolization (BOAI-TACE) has shown promise in the treatment of HCC and preservation of liver function. This prospective, single-arm study enrolled patients with HCC beyond up-to-7 criteria from five hospitals. The primary endpoint was objective response ratio (ORR) for BOAI-TACE, according to response evaluation criteria in cancer of the Liver (RECICL), at 2 months after treatment. Eighteen patients were enrolled in this study. Fourteen patients achieved response, resulting in an ORR of 77.8% (95% confidence interval [CI] 54.3-91.5%) according to both RECICL and modified response evaluation criteria in solid tumor (mRECIST) guidelines, meeting the primary endpoint. Disease control rate was 88.9% (95% CI 66.0-98.1%). No worsening of either Child-Pugh or albumin-bilirubin (ALBI) scores was observed. No serious adverse events were recorded, indicating that BOAI-TACE retains utility even in severe HCC cases while preserving liver function.

Keywords: Hepatocellular carcinoma; Liver function; Transarterial chemoembolization.

Publication types

  • Multicenter Study
  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents* / administration & dosage
  • Antineoplastic Agents* / therapeutic use
  • Balloon Occlusion* / methods
  • Carcinoma, Hepatocellular* / pathology
  • Carcinoma, Hepatocellular* / therapy
  • Chemoembolization, Therapeutic* / methods
  • Cisplatin* / administration & dosage
  • Cisplatin* / therapeutic use
  • Female
  • Gelatin* / administration & dosage
  • Humans
  • Liver Neoplasms* / pathology
  • Liver Neoplasms* / therapy
  • Male
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome

Substances

  • Cisplatin
  • Gelatin
  • Antineoplastic Agents

Grants and funding