biostudies-literatureOgasawara SAstra Zenecae059779https://www.ebi.ac.uk/biostudies/studies/S-EPMC8995959biostudies-literatureUnknown12(4)<h4>Introduction</h4>Advanced hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) has the worst prognosis among all phenotypes. This trial aims to evaluate whether treatment with durvalumab, alone or in combination with tremelimumab, plus particle therapy is a safe and synergistically effective treatment in patients with advanced HCC and MVI.<h4>Methods and analysis</h4>This phase Ib, multicentre (two sites in Japan), open-label, single-arm, investigator-initiated clinical trial will assess durvalumab monotherapy in combination with particle therapy (cohort A) and that of durvalumab plus tremelimumab in combination with particle therapy (cohort B) for patients with advanced HCC with MVI. Cohort A will receive 1500 mg durvalumab every 4 weeks. Cohort B will receive 1500 mg durvBMJ openDurvalumab with or without tremelimumab combined with particle therapy for advanced hepatocellular carcinoma with macrovascular invasion: protocol for the DEPARTURE phase Ib trial.PMC8995959ESR-19-20168Nakagawa MNakamoto SOgawa KSaito TNakagawa RKawasaki YYumita SWakatsuki MKobayashi KKanogawa NKurokawa TIshino TKato NSakuma TChiba TKojima RKanzaki HFujita NNakamura MTakahashi AKoroki KMuroyama RMakishima HOgasawara SOzawa YFujiwara KHanaoka HKondo TTsuji HKiyono SIwanaga TfalseDurvalumab with or without tremelimumab combined with particle therapy for advanced hepatocellular carcinoma with macrovascular invasion: protocol for the DEPARTURE phase Ib trial.<h4>Introduction</h4>Advanced hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) has the worst prognosis among all phenotypes. This trial aims to evaluate whether treatment with durvalumab, alone or in combination with tremelimumab, plus particle therapy is a safe and synergistically effective treatment in patients with advanced HCC and MVI.<h4>Methods and analysis</h4>This phase Ib, multicentre (two sites in Japan), open-label, single-arm, investigator-initiated clinical trial will assess durvalumab monotherapy in combination with particle therapy (cohort A) and that of durvalumab plus tremelimumab in combination with particle therapy (cohort B) for patients with advanced HCC with MVI. Cohort A will receive 1500 mg durvalumab every 4 weeks. Cohort B will receive 1500 mg durv2022-01-01T00:00:00Z2022 Apr2025-04-26T03:58:02.28Z2025-04-06T10:55:50.838ZS-EPMC89959593539631510.1136/bmjopen-2021-059779