Trial reportFrontiers in oncology2026
Balloon-occluded hepatic arterial infusion for unresectable hepatocellular carcinoma: a phase II trial interim analysis.
Trial report in Frontiers in oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Authors and funding
17 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: Hepatic arterial infusion chemotherapy (HAIC) is increasingly used to treat unresectable hepatocellular carcinoma (HCC), yet some HCC patients remain unresponsive or show disease progression. Purpose: This phase II study (ChiCTR2300077718) aimed to assess the efficacy and safety of balloon-occluded HAIC (bHAIC) based on the FOLFOX (oxaliplatin plus fluorouracil and leucovorin) regimen (bHAIC-FO) in unresectable HCC. Materials and methods: The present work is an investigator-initiated, multicenter, single-arm, prospective cohort trial. Unresectable HCC patients who had undergone a successful bHAIC procedure were included in the efficacy and safety analysis. After all patients received at least one post-bHAIC follow-up, an interim analysis was conducted in accordance with the predefined protocol. The primary endpoint of this interim analysis was the objective response rate (ORR). Secondary endpoints included changes in alpha-fetoprotein (AFP) levels and the occurrence of adverse events (AEs). Interim data were collected and analyzed using SPSS, version 27.0. Results: 50 patients received at least one successful bHAIC procedure and were included in the efficacy and safety analysis. The best ORR for 45 evaluable patients was 53.3% according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria, and 82.2% according to modified RECIST (mRECIST) criteria. In the patients population, 36 treatment-naive individuals achieved an 88.9% ORR according to mRECIST criteria, with 15 cases achieving radiological complete response (CR). Overall, 77.3% of patients with elevated AFP levels experienced a reduction of over 50% in their AFP levels. All AEs were manageable by medication or dose modifications. Conclusion: bHAIC-FO demonstrates encouraging efficacy and acceptable safety profiles in unresectable HCC treatment, particularly in treatment-naive patients. Clinical trial registration: www.chictr.org.cn, identifier ChiCTR2300077718.
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