Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma
Abstract Background The prognosis is still dismal, although several tyrosine kinase inhibitors (TKIs) with/without immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of biliary tract carcinoma (BTC). However, the combination of hepatic artery infusion chemotherapy (HAI...
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BMC
2025-06-01
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| Series: | World Journal of Surgical Oncology |
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| Online Access: | https://doi.org/10.1186/s12957-025-03882-3 |
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| author | Junying Wang Guangyu Zhu Jinhe Guo Gaojun Teng |
| author_facet | Junying Wang Guangyu Zhu Jinhe Guo Gaojun Teng |
| author_sort | Junying Wang |
| collection | DOAJ |
| description | Abstract Background The prognosis is still dismal, although several tyrosine kinase inhibitors (TKIs) with/without immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of biliary tract carcinoma (BTC). However, the combination of hepatic artery infusion chemotherapy (HAIC) with ICIs and TKIs may have potential in patients with BTC, according to the success of such a regimen for hepatocellular carcinoma. Hence, this study aimed to evaluate the preliminary efficacy and safety profile of combination therapy with HAIC plus ICI and lenvatinib in BTC patients. Methods This retrospective study included all BTC patients histologically diagnosed with combination therapy, which included HAIC with Gemox (Gemox-HAIC), programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1) inhibitor, and lenvatinib from July 2021 to October 2023. The outcomes were the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile. Results The median follow-up period was 7.0 months (range: 1.0–28.0 months). The ORR and DCR were 72.7% and 90.9%, respectively, with 0.0% CR, 72.7% PR, 18.2% SD, and 9.1% PD. The median PFS was 6.1 (4.3–8.0 (95% CI) months, and the 12-month accumulating PFS rate was 26.0%. The median OS was 10.3 (8.1–12.5 (95% CI) months, and the 12-month accumulating OS rate was 43.2%. The major adverse events included leukopenia (22.7%), thrombocytopenia (22.7%), vomiting (9.1%), etc. All AEs were grade 1–2 except for grade 3–4 leukopenia and 3–4 thrombocytopenia in one patient. Conclusion The combination therapy of Gemox-HAIC with ICIs and lenvatinib shows promising efficacy and tolerable safety profiles in BTC patients. |
| format | Article |
| id | doaj-art-c495c7b7bfdd4437a944df36df979bc8 |
| institution | Kabale University |
| issn | 1477-7819 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
| record_format | Article |
| series | World Journal of Surgical Oncology |
| spelling | doaj-art-c495c7b7bfdd4437a944df36df979bc82025-08-20T03:45:11ZengBMCWorld Journal of Surgical Oncology1477-78192025-06-012311810.1186/s12957-025-03882-3Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinomaJunying Wang0Guangyu Zhu1Jinhe Guo2Gaojun Teng3Center of Interventional Radiology & Vascular Surgery, Department of Radiology, Cultivation and Construction Site of the State Key Laboratory of Intelligent Imaging and Interventional Medicine (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Medical School, Southeast UniversityCenter of Interventional Radiology & Vascular Surgery, Department of Radiology, Cultivation and Construction Site of the State Key Laboratory of Intelligent Imaging and Interventional Medicine (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Medical School, Southeast UniversityCenter of Interventional Radiology & Vascular Surgery, Department of Radiology, Cultivation and Construction Site of the State Key Laboratory of Intelligent Imaging and Interventional Medicine (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Medical School, Southeast UniversityCenter of Interventional Radiology & Vascular Surgery, Department of Radiology, Cultivation and Construction Site of the State Key Laboratory of Intelligent Imaging and Interventional Medicine (Southeast University), Basic Medicine Research and Innovation Center of Ministry of Education, Zhongda Hospital, Medical School, Southeast UniversityAbstract Background The prognosis is still dismal, although several tyrosine kinase inhibitors (TKIs) with/without immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of biliary tract carcinoma (BTC). However, the combination of hepatic artery infusion chemotherapy (HAIC) with ICIs and TKIs may have potential in patients with BTC, according to the success of such a regimen for hepatocellular carcinoma. Hence, this study aimed to evaluate the preliminary efficacy and safety profile of combination therapy with HAIC plus ICI and lenvatinib in BTC patients. Methods This retrospective study included all BTC patients histologically diagnosed with combination therapy, which included HAIC with Gemox (Gemox-HAIC), programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1) inhibitor, and lenvatinib from July 2021 to October 2023. The outcomes were the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile. Results The median follow-up period was 7.0 months (range: 1.0–28.0 months). The ORR and DCR were 72.7% and 90.9%, respectively, with 0.0% CR, 72.7% PR, 18.2% SD, and 9.1% PD. The median PFS was 6.1 (4.3–8.0 (95% CI) months, and the 12-month accumulating PFS rate was 26.0%. The median OS was 10.3 (8.1–12.5 (95% CI) months, and the 12-month accumulating OS rate was 43.2%. The major adverse events included leukopenia (22.7%), thrombocytopenia (22.7%), vomiting (9.1%), etc. All AEs were grade 1–2 except for grade 3–4 leukopenia and 3–4 thrombocytopenia in one patient. Conclusion The combination therapy of Gemox-HAIC with ICIs and lenvatinib shows promising efficacy and tolerable safety profiles in BTC patients.https://doi.org/10.1186/s12957-025-03882-3Hepatic artery infusion chemotherapyImmune checkpoint inhibitorBiliary tract carcinomaTreatment efficacySafety profile |
| spellingShingle | Junying Wang Guangyu Zhu Jinhe Guo Gaojun Teng Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma World Journal of Surgical Oncology Hepatic artery infusion chemotherapy Immune checkpoint inhibitor Biliary tract carcinoma Treatment efficacy Safety profile |
| title | Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| title_full | Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| title_fullStr | Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| title_full_unstemmed | Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| title_short | Hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| title_sort | hepatic artery infusion chemotherapy plus an immune checkpoint inhibitor and lenvatinib for the treatment of biliary tract carcinoma |
| topic | Hepatic artery infusion chemotherapy Immune checkpoint inhibitor Biliary tract carcinoma Treatment efficacy Safety profile |
| url | https://doi.org/10.1186/s12957-025-03882-3 |
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