Efficacy and safety of lenvatinib–transcatheter arterial chemoembolisation sequential therapy followed by surgical resection for intermediate-stage hepatocellular carcinoma beyond Up-to-7 criteria: a study protocol for a multicentre, single-arm, prospective study
Hiroshi Aikata,
Hiroshi Sakai,
Michio Imamura,
Masahiro Ohira,
Tsuyoshi Kobayashi,
Ryosuke Nakano,
Naoki Tanimine,
Shintaro Kuroda,
Hiroyuki Tahara,
Kentaro Ide,
Hideki Ohdan,
Ko Oshita,
Yosuke Namba,
Sotaro Fukuhara,
Keiso Matsubara,
Daisuke Takei,
Wataru Okamoto,
Takashi Nakahara,
Tomokazu Kawaoka
Affiliations
Hiroshi Aikata
Research Center for Hepatology and Gastroenterology, Hiroshima University, Hiroshima, Japan
Hiroshi Sakai
Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Michio Imamura
Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Masahiro Ohira
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Tsuyoshi Kobayashi
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Ryosuke Nakano
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Naoki Tanimine
Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Shintaro Kuroda
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Hiroyuki Tahara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Kentaro Ide
Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Hideki Ohdan
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Ko Oshita
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Yosuke Namba
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Sotaro Fukuhara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Keiso Matsubara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Daisuke Takei
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Wataru Okamoto
Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Takashi Nakahara
Department of Gastroenterology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Tomokazu Kawaoka
Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan
Introduction The feasibility and efficacy of surgical resection following systemic therapy for intermediate-stage hepatocellular carcinoma (HCC) beyond the Up-to-7 criteria is unclear. The combination of lenvatinib (LEN) and transcatheter arterial chemoembolisation (TACE), termed LEN–TACE sequential therapy, has shown a high response rate and survival benefit in patients with intermediate-stage HCC. This trial aims to evaluate the efficacy and safety of LEN–TACE sequential therapy and the feasibility of surgical resection for intermediate-stage HCC beyond the Up-to-7 criteria.Methods and analysis This is a multicentre, single-arm, prospective clinical trial. Thirty patients with intermediate-stage HCC beyond the Up-to-7 criteria will be enrolled. Patients eligible for this study will undergo LEN–TACE sequential therapy in which LEN is administered for 4 weeks, followed by TACE, and then further LEN for another 4 weeks. Patients will be assessed for efficacy of LEN–TACE sequential therapy and resectability, and surgical resection will be performed if the HCC is considered radically resectable. The primary outcome of this study is the resection rate after LEN–TACE sequential therapy. The secondary outcomes are the objective response rate of LEN–TACE sequential therapy, safety, curative resection rate, overall survival and recurrence-free survival.Ethics and dissemination This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB210003), and has been registered with the Japan Registry of Clinical Trials (jRCTs061220007). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.Trial registration number jRCTs061220007 (https://jrct.niph.go.jp/latest-detail/jRCTs061220007).
