Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial
Abstract This prospective, nonrandomized, open-label phase 2 trial (Chinese Clinical Trial Registry, ChiCTR2200061906) aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Publishing Group
2025-02-01
|
| Series: | Signal Transduction and Targeted Therapy |
| Online Access: | https://doi.org/10.1038/s41392-025-02160-8 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823861558576414720 |
|---|---|
| author | Run-Cong Nie Shu-Qiang Yuan Ya Ding Yong-Ming Chen Yuan-Fang Li Cheng-Cai Liang Mu-Yan Cai Guo-Ming Chen Wei Wang Xiao-Wei Sun De-Sheng Weng Dan-Dan Li Jing-Jing Zhao Xiao-Jiang Chen Yuan-Xiang Guan Zhi-Min Liu Yao Liang Ma Luo Jun Chi Hai-Bo Qiu Zhi-Wei Zhou Xiao-Shi Zhang Ying-Bo Chen |
| author_facet | Run-Cong Nie Shu-Qiang Yuan Ya Ding Yong-Ming Chen Yuan-Fang Li Cheng-Cai Liang Mu-Yan Cai Guo-Ming Chen Wei Wang Xiao-Wei Sun De-Sheng Weng Dan-Dan Li Jing-Jing Zhao Xiao-Jiang Chen Yuan-Xiang Guan Zhi-Min Liu Yao Liang Ma Luo Jun Chi Hai-Bo Qiu Zhi-Wei Zhou Xiao-Shi Zhang Ying-Bo Chen |
| author_sort | Run-Cong Nie |
| collection | DOAJ |
| description | Abstract This prospective, nonrandomized, open-label phase 2 trial (Chinese Clinical Trial Registry, ChiCTR2200061906) aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma (GEJA). This study enrolled patients with GEJA clinically staged as cT3-4aNanyM0 or cT1-2N+M0 from October 2022 to June 2023. Eligible patients were administered three preoperative and five postoperative 3-week cycles of treatment with PD-1 antibody tislelizumab plus SOX (S-1 and oxaliplatin) regimen. The primary endpoint was major pathological response (MPR) rate. Thirty-two patients were enrolled. The median age was 60 years (range: 28–74 years), and 53.1% (17/32) patients were Siewert III type. All patients received at least one cycle of assigned preoperative treatment, and 93.8% (30/32) patients completed three cycles of assigned preoperative tislelizumab and SOX. The R0 resection rate was 96.9% (31/32). MPR, pathological complete response (pCR) of primary tumors and ypT0N0 rates were 50.0% (16/32, 95% CI: 31.9–68.1%), 28.1% (9/32, 95% CI: 13.7–46.7%) and 25.0% (8/32, 95% CI: 11.5–43.4%), respectively. The surgical morbidity rate was 15.6% (5/32), and no 30-day mortality was observed. In the preoperative and postoperative treatment periods, the rate of treatment-related grade 3–4 adverse events was 31.2% (10/32). At the date of 7th Jan 2025, 8 (25.0%) patients occurred recurrence. Therefore, perioperative tislelizumab plus chemotherapy demonstrated significantly improved pathological regression and might be a promising option for patients with locally advanced resectable GEJA. |
| format | Article |
| id | doaj-art-547443ba1dd242e3b4fee9aca9bc20c1 |
| institution | Kabale University |
| issn | 2059-3635 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Publishing Group |
| record_format | Article |
| series | Signal Transduction and Targeted Therapy |
| spelling | doaj-art-547443ba1dd242e3b4fee9aca9bc20c12025-02-09T12:56:34ZengNature Publishing GroupSignal Transduction and Targeted Therapy2059-36352025-02-011011910.1038/s41392-025-02160-8Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trialRun-Cong Nie0Shu-Qiang Yuan1Ya Ding2Yong-Ming Chen3Yuan-Fang Li4Cheng-Cai Liang5Mu-Yan Cai6Guo-Ming Chen7Wei Wang8Xiao-Wei Sun9De-Sheng Weng10Dan-Dan Li11Jing-Jing Zhao12Xiao-Jiang Chen13Yuan-Xiang Guan14Zhi-Min Liu15Yao Liang16Ma Luo17Jun Chi18Hai-Bo Qiu19Zhi-Wei Zhou20Xiao-Shi Zhang21Ying-Bo Chen22Department of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Pathology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Medical Imaging, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Endoscopy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Biotherapy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineAbstract This prospective, nonrandomized, open-label phase 2 trial (Chinese Clinical Trial Registry, ChiCTR2200061906) aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma (GEJA). This study enrolled patients with GEJA clinically staged as cT3-4aNanyM0 or cT1-2N+M0 from October 2022 to June 2023. Eligible patients were administered three preoperative and five postoperative 3-week cycles of treatment with PD-1 antibody tislelizumab plus SOX (S-1 and oxaliplatin) regimen. The primary endpoint was major pathological response (MPR) rate. Thirty-two patients were enrolled. The median age was 60 years (range: 28–74 years), and 53.1% (17/32) patients were Siewert III type. All patients received at least one cycle of assigned preoperative treatment, and 93.8% (30/32) patients completed three cycles of assigned preoperative tislelizumab and SOX. The R0 resection rate was 96.9% (31/32). MPR, pathological complete response (pCR) of primary tumors and ypT0N0 rates were 50.0% (16/32, 95% CI: 31.9–68.1%), 28.1% (9/32, 95% CI: 13.7–46.7%) and 25.0% (8/32, 95% CI: 11.5–43.4%), respectively. The surgical morbidity rate was 15.6% (5/32), and no 30-day mortality was observed. In the preoperative and postoperative treatment periods, the rate of treatment-related grade 3–4 adverse events was 31.2% (10/32). At the date of 7th Jan 2025, 8 (25.0%) patients occurred recurrence. Therefore, perioperative tislelizumab plus chemotherapy demonstrated significantly improved pathological regression and might be a promising option for patients with locally advanced resectable GEJA.https://doi.org/10.1038/s41392-025-02160-8 |
| spellingShingle | Run-Cong Nie Shu-Qiang Yuan Ya Ding Yong-Ming Chen Yuan-Fang Li Cheng-Cai Liang Mu-Yan Cai Guo-Ming Chen Wei Wang Xiao-Wei Sun De-Sheng Weng Dan-Dan Li Jing-Jing Zhao Xiao-Jiang Chen Yuan-Xiang Guan Zhi-Min Liu Yao Liang Ma Luo Jun Chi Hai-Bo Qiu Zhi-Wei Zhou Xiao-Shi Zhang Ying-Bo Chen Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial Signal Transduction and Targeted Therapy |
| title | Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial |
| title_full | Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial |
| title_fullStr | Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial |
| title_full_unstemmed | Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial |
| title_short | Perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma (NEOSUMMIT-03): a prospective, nonrandomized, open-label, phase 2 trial |
| title_sort | perioperative tislelizumab plus chemotherapy for locally advanced gastroesophageal junction adenocarcinoma neosummit 03 a prospective nonrandomized open label phase 2 trial |
| url | https://doi.org/10.1038/s41392-025-02160-8 |
| work_keys_str_mv | AT runcongnie perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT shuqiangyuan perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yading perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yongmingchen perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yuanfangli perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT chengcailiang perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT muyancai perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT guomingchen perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT weiwang perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT xiaoweisun perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT deshengweng perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT dandanli perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT jingjingzhao perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT xiaojiangchen perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yuanxiangguan perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT zhiminliu perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yaoliang perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT maluo perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT junchi perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT haiboqiu perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT zhiweizhou perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT xiaoshizhang perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial AT yingbochen perioperativetislelizumabpluschemotherapyforlocallyadvancedgastroesophagealjunctionadenocarcinomaneosummit03aprospectivenonrandomizedopenlabelphase2trial |