Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial
Abstract Background The development of systemic therapy, including targeted drugs and immune checkpoint inhibitors, has significantly improved the prognosis of patients with advanced unresectable hepatocellular carcinoma (uHCC). Hepatic arterial infusion chemotherapy (HAIC) has been gradually applie...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s12885-025-14250-5 |
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| author | Kugeluke Yalikun Zhongchao Li Jianxin Zhang Zhibin Chang Mingming Li Zhicheng Sun Zhaogang Liu Yue Yang Lei Xu Lei Li Chengsheng Zhang Pengfei Sun Jingtao Zhong Kai Cui Xuetao Shi Bo Zhang Lei Zhao |
| author_facet | Kugeluke Yalikun Zhongchao Li Jianxin Zhang Zhibin Chang Mingming Li Zhicheng Sun Zhaogang Liu Yue Yang Lei Xu Lei Li Chengsheng Zhang Pengfei Sun Jingtao Zhong Kai Cui Xuetao Shi Bo Zhang Lei Zhao |
| author_sort | Kugeluke Yalikun |
| collection | DOAJ |
| description | Abstract Background The development of systemic therapy, including targeted drugs and immune checkpoint inhibitors, has significantly improved the prognosis of patients with advanced unresectable hepatocellular carcinoma (uHCC). Hepatic arterial infusion chemotherapy (HAIC) has been gradually applied to the treatment of advanced uHCC, showing good potential as conversion therapy. We aimed to investigate the efficacy and safety of HAIC combined with camrelizumab and apatinib as conversion therapy for uHCC. Methods This study was a single-arm exploratory trial (NCT05099848) in patients with uHCC. Eligible patients received apatinib 250 mg once daily, camrelizumab 200 mg on day 3, and HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2 at hours 0–2, leucovorin 400 mg/m2 at hours 2–3, and fluorouracil 400 mg/m2 at hour 3, followed by fluorouracil 2400 mg/m2 for 46 h) on days 4–5 of each 21-day cycle for up to 8 cycles. Primary endpoints were conversion rate and margin-free (R0) resection rate. Results Between March 2021 and July 2023, 19 patients were enrolled. Median follow-up was 14.9 months (interquartile range, 10.9–21.1). Disease became resectable in 14 (73.7%) of 19 patients; nine (47.4%) patients received R0 resection, while five (26.3%) refused surgery and opted for observation. Three (33.3%) of nine patients with surgery achieved major pathological response, including two (22.2%) with pathological complete response. Objective response and disease control rates were 47.4% (9/19) and 89.5% (17/19) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 and both 89.5% (17/19) per modified RECIST. Survival data were immature. Fourteen (73.7%) of 19 patients had grade 3 or higher treatment-related adverse events, with the most common being increased alanine aminotransferase or aspartate aminotransferase (seven [36.8%]) and increased lymphocyte count (six [31.6%]). No treatment-related deaths occurred. Conclusions The combination of HAIC, camrelizumab, and apatinib as conversion therapy shows promising clinical benefits and a manageable safety profile in patients with uHCC. Future randomized controlled trials are warranted. Trial registration ClinicalTrials.gov NCT05099848. Registered on October 13, 2021. |
| format | Article |
| id | doaj-art-95bca563c2c549a8b5cb05472c069763 |
| institution | OA Journals |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj-art-95bca563c2c549a8b5cb05472c0697632025-08-20T02:15:12ZengBMCBMC Cancer1471-24072025-05-0125111110.1186/s12885-025-14250-5Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trialKugeluke Yalikun0Zhongchao Li1Jianxin Zhang2Zhibin Chang3Mingming Li4Zhicheng Sun5Zhaogang Liu6Yue Yang7Lei Xu8Lei Li9Chengsheng Zhang10Pengfei Sun11Jingtao Zhong12Kai Cui13Xuetao Shi14Bo Zhang15Lei Zhao16The Affiliated Cancer Hospital of Xinjiang Medical UniversityDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Intervention Oncology, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteDepartment of Hepatobiliary Surgery, Shandong First Medical University and Shandong Academy of Medical Sciences, Shandong Cancer Hospital and InstituteThe Affiliated Cancer Hospital of Xinjiang Medical UniversityAbstract Background The development of systemic therapy, including targeted drugs and immune checkpoint inhibitors, has significantly improved the prognosis of patients with advanced unresectable hepatocellular carcinoma (uHCC). Hepatic arterial infusion chemotherapy (HAIC) has been gradually applied to the treatment of advanced uHCC, showing good potential as conversion therapy. We aimed to investigate the efficacy and safety of HAIC combined with camrelizumab and apatinib as conversion therapy for uHCC. Methods This study was a single-arm exploratory trial (NCT05099848) in patients with uHCC. Eligible patients received apatinib 250 mg once daily, camrelizumab 200 mg on day 3, and HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2 at hours 0–2, leucovorin 400 mg/m2 at hours 2–3, and fluorouracil 400 mg/m2 at hour 3, followed by fluorouracil 2400 mg/m2 for 46 h) on days 4–5 of each 21-day cycle for up to 8 cycles. Primary endpoints were conversion rate and margin-free (R0) resection rate. Results Between March 2021 and July 2023, 19 patients were enrolled. Median follow-up was 14.9 months (interquartile range, 10.9–21.1). Disease became resectable in 14 (73.7%) of 19 patients; nine (47.4%) patients received R0 resection, while five (26.3%) refused surgery and opted for observation. Three (33.3%) of nine patients with surgery achieved major pathological response, including two (22.2%) with pathological complete response. Objective response and disease control rates were 47.4% (9/19) and 89.5% (17/19) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 and both 89.5% (17/19) per modified RECIST. Survival data were immature. Fourteen (73.7%) of 19 patients had grade 3 or higher treatment-related adverse events, with the most common being increased alanine aminotransferase or aspartate aminotransferase (seven [36.8%]) and increased lymphocyte count (six [31.6%]). No treatment-related deaths occurred. Conclusions The combination of HAIC, camrelizumab, and apatinib as conversion therapy shows promising clinical benefits and a manageable safety profile in patients with uHCC. Future randomized controlled trials are warranted. Trial registration ClinicalTrials.gov NCT05099848. Registered on October 13, 2021.https://doi.org/10.1186/s12885-025-14250-5ApatinibCamrelizumabHepatic arterial infusion chemotherapyUnresectable hepatocellular carcinomaConversion therapy |
| spellingShingle | Kugeluke Yalikun Zhongchao Li Jianxin Zhang Zhibin Chang Mingming Li Zhicheng Sun Zhaogang Liu Yue Yang Lei Xu Lei Li Chengsheng Zhang Pengfei Sun Jingtao Zhong Kai Cui Xuetao Shi Bo Zhang Lei Zhao Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial BMC Cancer Apatinib Camrelizumab Hepatic arterial infusion chemotherapy Unresectable hepatocellular carcinoma Conversion therapy |
| title | Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial |
| title_full | Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial |
| title_fullStr | Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial |
| title_full_unstemmed | Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial |
| title_short | Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial |
| title_sort | hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma a single arm exploratory trial |
| topic | Apatinib Camrelizumab Hepatic arterial infusion chemotherapy Unresectable hepatocellular carcinoma Conversion therapy |
| url | https://doi.org/10.1186/s12885-025-14250-5 |
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