PMID- 38194882 OWN - NLM STAT- MEDLINE DCOM- 20240126 LR - 20240206 IS - 2059-7029 (Electronic) IS - 2059-7029 (Linking) VI - 9 IP - 1 DP - 2024 Jan TI - Intraperitoneal PD-1 monoclonal antibody for the treatment of advanced primary liver cancer with malignant ascites: a single-arm, single-center, phase Ib trial. PG - 102206 LID - S2059-7029(23)01447-3 [pii] LID - 10.1016/j.esmoop.2023.102206 [doi] LID - 102206 AB - BACKGROUND: Advanced primary liver cancer patients with malignant ascites have a poor prognosis and lack effective treatment plans. This phase Ib study aims to explore the safety and clinical efficacy of intraperitoneal anti-programmed cell death protein 1 (PD-1) antibody in these patients. PATIENTS AND METHODS: Patients received sintilimab 100 mg intraperitoneally plus best supportive care on days 1, 8, and 15 in three cycles of 4 weeks. The course was repeated every 28 days until intolerable toxicity had developed or disease progression. The primary endpoint was safety, while the secondary endpoints were objective response rate (ORR), ascites control rate (ACR), and overall survival (OS). RESULTS: From February 2021 through November 2022, a total of 21 patients (14 hepatocellular carcinoma and 7 cholangiocarcinoma) were enrolled to receive intraperitoneal sintilimab. Twelve patients had adverse events (AEs). The most common grade 3 AEs were fatigue, rash, and abdominal pain. No grade >/=4 AEs occurred in any patients. ORR was only evaluated in 13 patients, including partial response in 4, stable disease in 7, and progressive disease in 2. A reduction in the median maximum diameter of the tumor after treatment was observed; however, there was no statistical significance among patients. The objective remission rate of ascites was 43.75%, and the median OS for all 21 patients was 17.6 weeks. CONCLUSIONS: This exploratory study represents the first trial to demonstrate the safety and clinical efficacy of intraperitoneal anti-PD-1 antibody administration. No unexpected safety concerns were identified. A large, multicenter, prospective study is needed to confirm the promising clinical efficacy. CI - Copyright (c) 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved. FAU - Chen, C AU - Chen C AD - Department of Oncology, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Li, Z AU - Li Z AD - Department of Oncology, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Xiong, X AU - Xiong X AD - Department of Hepatology, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Yao, A AU - Yao A AD - Department of Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Wang, S AU - Wang S AD - Department of Research Institute of General Surgery, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Liu, X AU - Liu X AD - Department of Oncology, Jinling Hospital, Nanjing Medical University, Nanjing. FAU - Liu, X AU - Liu X AD - Department of Oncology, Jinling Hospital, Nanjing Medical University, Nanjing. Electronic address: njjloncologylxf@163.com. FAU - Wang, J AU - Wang J AD - Department of Hematology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing; Yizheng Hospital of Nanjing Drum Tower Hospital Group, Yizheng, PR China. Electronic address: yz3466599@hotmail.com. LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Multicenter Study DEP - 20240109 PL - England TA - ESMO Open JT - ESMO open JID - 101690685 RN - 0 (Antibodies, Monoclonal) RN - 0 (Programmed Cell Death 1 Receptor) SB - IM MH - Humans MH - Antibodies, Monoclonal MH - Ascites/drug therapy/etiology MH - Programmed Cell Death 1 Receptor MH - *Carcinoma, Hepatocellular MH - *Liver Neoplasms/complications/drug therapy PMC - PMC10820330 OTO - NOTNLM OT - efficacy OT - hepatocellular carcinoma OT - immunotherapy OT - liver cancer OT - safety OT - sintilimab EDAT- 2024/01/10 00:42 MHDA- 2024/01/26 06:43 PMCR- 2024/01/09 CRDT- 2024/01/09 18:16 PHST- 2023/10/18 00:00 [received] PHST- 2023/11/27 00:00 [revised] PHST- 2023/11/27 00:00 [accepted] PHST- 2024/01/26 06:43 [medline] PHST- 2024/01/10 00:42 [pubmed] PHST- 2024/01/09 18:16 [entrez] PHST- 2024/01/09 00:00 [pmc-release] AID - S2059-7029(23)01447-3 [pii] AID - 102206 [pii] AID - 10.1016/j.esmoop.2023.102206 [doi] PST - ppublish SO - ESMO Open. 2024 Jan;9(1):102206. doi: 10.1016/j.esmoop.2023.102206. Epub 2024 Jan 9.