Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma
Abstract Advanced esophageal squamous cell carcinoma (ESCC) patients exhibit a ~ 50% objective response rate (ORR) and median progression-free survival (mPFS) of just 5–7 months when undergoing first-line immune-chemotherapeutic treatment, underscoring pronounced unmet clinical need. We assessed the...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-06625-2 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849238256699310080 |
|---|---|
| author | Mingfang Xu Yu Pu Yuzhu Jiang Yingda Liu Yan Feng Xiaodong Zhao Mengxia Li |
| author_facet | Mingfang Xu Yu Pu Yuzhu Jiang Yingda Liu Yan Feng Xiaodong Zhao Mengxia Li |
| author_sort | Mingfang Xu |
| collection | DOAJ |
| description | Abstract Advanced esophageal squamous cell carcinoma (ESCC) patients exhibit a ~ 50% objective response rate (ORR) and median progression-free survival (mPFS) of just 5–7 months when undergoing first-line immune-chemotherapeutic treatment, underscoring pronounced unmet clinical need. We assessed the efficacy and safety of Anlotinib plus Camrelizumab and chemotherapy for advanced, unresectable, or metastatic ESCC. This is an open-label, investigator-initiated, phase 2, non-randomized clinical trial enrolled patients from August 3, 2020, to August 10, 2022. Patients with treatment-naive unresectable stage III or IV ESCC received treatment which was patient-selected, including chemotherapy + camrelizumab + Anlotinib (TCAC group) or chemotherapy + Camrelizumab (TCC group) induction therapy for 4–6 cycles, followed by maintenance therapy. The primary endpoint was ORR, while secondary endpoints included mPFS, median overall survival (mOS), disease control rate (DCR), and treatment-related adverse events (TRAEs). 30 patients were included in each group. Over a median 14.5-month follow-up period, the ORR was 90.0%, 43.3%(P < 0 0.001) and the mPFS was 16.03, 7.30 months (HR 0.35, 95%CI, 0.19–0.65; P < 0 0.001) in TCAC and TCC groups, respectively. Grade 3 TRAEs were experienced by 12 patients (40.0%) in TCAC group, including decreased neutrophil counts (5 [16.7%]), decreased white blood cell counts (4 [13.3%]), reduced platelet counts (3 [10%]), and hypertension (2 [6.7%]). No patients experienced grade 4–5 TRAEs. The combination of Anlotinib plus Camrelizumab and chemotherapy had promising efficacy among patients with advanced ESCC in this study, which may be a promising first-line treatment regimen. Trial registration: Registered with ClinicalTrials.gov, NCT04471480. 15/07/2020. |
| format | Article |
| id | doaj-art-d67f61947121473e9a80c47fa4d4dfc3 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-d67f61947121473e9a80c47fa4d4dfc32025-08-20T04:01:41ZengNature PortfolioScientific Reports2045-23222025-07-0115111210.1038/s41598-025-06625-2Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinomaMingfang Xu0Yu Pu1Yuzhu Jiang2Yingda Liu3Yan Feng4Xiaodong Zhao5Mengxia Li6Department of Cancer center, Daping Hospital, Army Medical UniversityDepartment of Cancer center, Daping Hospital, Army Medical UniversityDepartment of Cancer center, Daping Hospital, Army Medical UniversityThe Second Affiliated Hospital of Chongqing Medical UniversityDepartment of Cancer center, Daping Hospital, Army Medical UniversityThe Second Affiliated Hospital of Chongqing Medical UniversityDepartment of Cancer center, Daping Hospital, Army Medical UniversityAbstract Advanced esophageal squamous cell carcinoma (ESCC) patients exhibit a ~ 50% objective response rate (ORR) and median progression-free survival (mPFS) of just 5–7 months when undergoing first-line immune-chemotherapeutic treatment, underscoring pronounced unmet clinical need. We assessed the efficacy and safety of Anlotinib plus Camrelizumab and chemotherapy for advanced, unresectable, or metastatic ESCC. This is an open-label, investigator-initiated, phase 2, non-randomized clinical trial enrolled patients from August 3, 2020, to August 10, 2022. Patients with treatment-naive unresectable stage III or IV ESCC received treatment which was patient-selected, including chemotherapy + camrelizumab + Anlotinib (TCAC group) or chemotherapy + Camrelizumab (TCC group) induction therapy for 4–6 cycles, followed by maintenance therapy. The primary endpoint was ORR, while secondary endpoints included mPFS, median overall survival (mOS), disease control rate (DCR), and treatment-related adverse events (TRAEs). 30 patients were included in each group. Over a median 14.5-month follow-up period, the ORR was 90.0%, 43.3%(P < 0 0.001) and the mPFS was 16.03, 7.30 months (HR 0.35, 95%CI, 0.19–0.65; P < 0 0.001) in TCAC and TCC groups, respectively. Grade 3 TRAEs were experienced by 12 patients (40.0%) in TCAC group, including decreased neutrophil counts (5 [16.7%]), decreased white blood cell counts (4 [13.3%]), reduced platelet counts (3 [10%]), and hypertension (2 [6.7%]). No patients experienced grade 4–5 TRAEs. The combination of Anlotinib plus Camrelizumab and chemotherapy had promising efficacy among patients with advanced ESCC in this study, which may be a promising first-line treatment regimen. Trial registration: Registered with ClinicalTrials.gov, NCT04471480. 15/07/2020.https://doi.org/10.1038/s41598-025-06625-2Esophageal squamous cell carcinomaAnlotinibICIsFirst-line treatment |
| spellingShingle | Mingfang Xu Yu Pu Yuzhu Jiang Yingda Liu Yan Feng Xiaodong Zhao Mengxia Li Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma Scientific Reports Esophageal squamous cell carcinoma Anlotinib ICIs First-line treatment |
| title | Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma |
| title_full | Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma |
| title_fullStr | Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma |
| title_full_unstemmed | Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma |
| title_short | Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma |
| title_sort | anlotinib plus camrelizumab and chemotherapy as first line treatment in patients with advanced esophageal squamous cell carcinoma |
| topic | Esophageal squamous cell carcinoma Anlotinib ICIs First-line treatment |
| url | https://doi.org/10.1038/s41598-025-06625-2 |
| work_keys_str_mv | AT mingfangxu anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT yupu anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT yuzhujiang anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT yingdaliu anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT yanfeng anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT xiaodongzhao anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma AT mengxiali anlotinibpluscamrelizumabandchemotherapyasfirstlinetreatmentinpatientswithadvancedesophagealsquamouscellcarcinoma |