Evidence map›Paper›PMID 42665190›Full record

ArticleJHEP reports : innovation in hepatology2026

Atezolizumab-bevacizumab with or without cisplatin-based HAIC for unresectable HCC: A randomized phase II trial.

Yasuto Takeuchi, Masahiko Sue, Nozomi Miyake, Takuya Adachi, Hideki Onishi, Miwa Kawanaka, Akinobu Takaki, Kazuhiro Nouso, Kazuya Kariyama, Tetsuya Yasunaka and 11 more

Abstract read
In one paragraph

Article in JHEP reports : innovation in hepatology, 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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1 · What the graph read from it

What it found

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2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

21 authors.

Yasuto TakeuchiDepartment of Gastroenterology, Okayama University Hospital, Japan. Electronic address: pwqs6abz@s.okayama-u.ac.jp.
Masahiko SueDepartment of Gastroenterology, Okayama University Hospital, Japan.
Nozomi MiyakeDepartment of Gastroenterology, Okayama University Hospital, Japan.
Takuya AdachiDepartment of Gastroenterology, Okayama University Hospital, Japan.
Hideki OnishiDepartment of Gastroenterology, Okayama University Hospital, Japan.
Miwa KawanakaDepartment of Gastroenterology, Okayama University Hospital, Japan.
Akinobu TakakiDepartment of Gastroenterology, Okayama University Hospital, Japan.
Kazuhiro NousoDepartment of Gastroenterology, Okayama City Hospital, Japan.
Kazuya KariyamaDepartment of Gastroenterology, Okayama City Hospital, Japan.
Tetsuya YasunakaDepartment of Gastroenterology, Fukuyama City Hospital, Japan.
Kenji KuwakiDepartment of Gastroenterology, Okayama Saiseikai General Hospital, Japan.
Junichi ToshimoriDepartment of Gastroenterology, Japanese Red Cross Okayama Hospital, Japan.
Shota IwadoDepartment of Gastroenterology, Hiroshima City Hospital, Japan.
Akio MoriyaDepartment of Gastroenterology, Mitoyo General Hospital, Japan.
Hiroaki HagiharaDepartment of Gastroenterology, Sumitomo Besshi Hospital, Japan.
Hiroyuki TakabatakeDepartment of Gastroenterology, Kurashiki Central Hospital, Japan.
Masahiro SakataDepartment of Gastroenterology, Fukuyama Medical Center, Japan.
Takeshi HatanakaDepartment of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan.
Shigeo ShimoseDivision of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Takumi KawaguchiDivision of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Motoyuki OtsukaDepartment of Gastroenterology, Okayama University Hospital, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsAtezolizumab plus bevacizumab (ATZ/BEV) is the global standard first-line treatment for unresectable hepatocellular carcinoma (HCC). However, the objective response rate (ORR) is approximately 30%. Hepatic arterial infusion chemotherapy (HAIC) with cisplatin may enhance its efficacy through locoregional cytoreduction and immunological modulation. We conducted a randomized phase II trial to evaluate whether sequential cisplatin HAIC plus ATZ/BEV (CDDP+ATZ/BEV) improves clinical outcomes compared to ATZ/BEV alone.

methodsIn this multicenter, open-label trial, patients with unresectable HCC were randomized 1:1 to receive cisplatin HAIC within 8 weeks before initiation of ATZ/BEV or ATZ/BEV alone. The primary endpoint was ORR.

resultsBetween December 2021 and December 2024, 70 patients were enrolled in this study (CDDP+ATZ/BEV, n = 35; ATZ/BEV, n = 35). The primary endpoint, ORR, was numerically higher in the CDDP+ATZ/BEV group than in the ATZ/BEV group but did not reach statistical significance (45.7% vs. 28.6%; p = 0.095). Median progression-free survival (PFS) was longer in the CDDP+ATZ/BEV group (8.3 vs. 6.6 months; HR 0.53; p = 0.036), and median duration of response was not reached vs. 4.6 months (HR 0.4; p = 0.11). The median overall survival (OS) was 28.1 vs. 31.0 months (HR 0.95; p = 0.88). Grade 3-4 treatment-related adverse events occurred in 20.0% and 22.9% of patients, respectively.

conclusionsThe primary endpoint of ORR was not met. However, exploratory analyses demonstrated longer PFS without additional safety concerns. Further evaluation in phase III trials is warranted. IMPACT AND IMPLICATIONS: This multicenter randomized phase II trial provides evidence that sequential cisplatin hepatic arterial infusion chemotherapy followed by atezolizumab-bevacizumab may prolong disease control without increasing toxicity in patients with unresectable hepatocellular carcinoma. Although the primary endpoint was not met and the progression-free survival benefit was observed in exploratory analyses, these findings support further investigation of this strategy in phase III trials and provide a rationale for evaluating liver-directed combination approaches to optimize first-line immunotherapy. CLINICAL TRIAL NUMBER: Japan Registry of Clinical Trials (jRCTs061210065).

Indexed as

Atezolizumab plus bevacizumabCisplatin hepatic arterial infusion chemotherapyHepatocellular carcinoma

Identifiers

PMID42665190
PMCPMC13659464

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.