Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial
Abstract Evidence-guided regimens for advanced gastric cancer (AGC) in patients with performance status 2 (PS 2) are limited. Here, we proposed a structured therapeutic framework termed “performance status-matched strategy”, and further conducted the APICAL-GC trial (NCT04278222). This open-label, s...
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Nature Portfolio
2025-05-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-025-60317-z |
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| author | Ke Liu Bao-Dong Qin Shi-Qi Chen Xue Zhong Xiao-Peng Duan Ying Wu Zhan Wang Yan Ling Li Sun Chen-Yang Ye Dong-Min Shi Ning Gao Xiao-Dong Jiao Yuan-Sheng Zang |
| author_facet | Ke Liu Bao-Dong Qin Shi-Qi Chen Xue Zhong Xiao-Peng Duan Ying Wu Zhan Wang Yan Ling Li Sun Chen-Yang Ye Dong-Min Shi Ning Gao Xiao-Dong Jiao Yuan-Sheng Zang |
| author_sort | Ke Liu |
| collection | DOAJ |
| description | Abstract Evidence-guided regimens for advanced gastric cancer (AGC) in patients with performance status 2 (PS 2) are limited. Here, we proposed a structured therapeutic framework termed “performance status-matched strategy”, and further conducted the APICAL-GC trial (NCT04278222). This open-label, single-arm phase II study evaluated the efficacy and safety of anlotinib combined with toripalimab among 24 treatment-naïve AGC patients with PS 2. The primary outcome was the objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile. This trial met its prespecified endpoints, demonstrating an ORR of 58.3% (95%CI 36.6–77.9) with a DoR of 12.1 months (range: 1.43–48.5), and a DCR of 95.8% (95%CI 78.9–99.9). Median PFS reached 7.33 months (95%CI 3.83–17.1), while median OS was 15.9 months (95%CI 7.73–23.2). Treatment-related adverse events (TRAEs) of any grade occurred in 21 patients (87.5%), with grade-3 TRAEs observed in 7 patients (29.2%). No grade-4/5 TRAEs were reported. These findings provide a rationale for anlotinib plus toripalimab as a promising chemotherapy-free option for the first-line treatment of AGC patients with PS 2 under the performance status-matched strategy, showing comparable anticancer activity and a lower occurrence rate of TRAEs. |
| format | Article |
| id | doaj-art-2048febe34834d928f8879d4c193871b |
| institution | OA Journals |
| issn | 2041-1723 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj-art-2048febe34834d928f8879d4c193871b2025-08-20T02:00:09ZengNature PortfolioNature Communications2041-17232025-05-0116111010.1038/s41467-025-60317-zAnlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trialKe Liu0Bao-Dong Qin1Shi-Qi Chen2Xue Zhong3Xiao-Peng Duan4Ying Wu5Zhan Wang6Yan Ling7Li Sun8Chen-Yang Ye9Dong-Min Shi10Ning Gao11Xiao-Dong Jiao12Yuan-Sheng Zang13Department of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical University3D Medicines IncDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityDepartment of Medical Oncology, Changzheng Hospital, Naval Medical UniversityAbstract Evidence-guided regimens for advanced gastric cancer (AGC) in patients with performance status 2 (PS 2) are limited. Here, we proposed a structured therapeutic framework termed “performance status-matched strategy”, and further conducted the APICAL-GC trial (NCT04278222). This open-label, single-arm phase II study evaluated the efficacy and safety of anlotinib combined with toripalimab among 24 treatment-naïve AGC patients with PS 2. The primary outcome was the objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profile. This trial met its prespecified endpoints, demonstrating an ORR of 58.3% (95%CI 36.6–77.9) with a DoR of 12.1 months (range: 1.43–48.5), and a DCR of 95.8% (95%CI 78.9–99.9). Median PFS reached 7.33 months (95%CI 3.83–17.1), while median OS was 15.9 months (95%CI 7.73–23.2). Treatment-related adverse events (TRAEs) of any grade occurred in 21 patients (87.5%), with grade-3 TRAEs observed in 7 patients (29.2%). No grade-4/5 TRAEs were reported. These findings provide a rationale for anlotinib plus toripalimab as a promising chemotherapy-free option for the first-line treatment of AGC patients with PS 2 under the performance status-matched strategy, showing comparable anticancer activity and a lower occurrence rate of TRAEs.https://doi.org/10.1038/s41467-025-60317-z |
| spellingShingle | Ke Liu Bao-Dong Qin Shi-Qi Chen Xue Zhong Xiao-Peng Duan Ying Wu Zhan Wang Yan Ling Li Sun Chen-Yang Ye Dong-Min Shi Ning Gao Xiao-Dong Jiao Yuan-Sheng Zang Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial Nature Communications |
| title | Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial |
| title_full | Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial |
| title_fullStr | Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial |
| title_full_unstemmed | Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial |
| title_short | Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial |
| title_sort | anlotinib plus toripalimab as a first line treatment in patients with advanced gastric cancer and performance status 2 the phase ii apical gc trial |
| url | https://doi.org/10.1038/s41467-025-60317-z |
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