A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study
Abstract Background Perioperative chemotherapy (ChT) and preoperative chemoradiation (CRT) are both the standard treatments for locally advanced gastric cancer (LAGC). CRT can achieve a higher pathological complete regression (pCR) rate, but whether this higher pCR rate can be transformed into a lon...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-022-09786-9 |
| _version_ | 1811328712426127360 |
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| author | Menglong Zhou Wang Yang Yan Xuan Wei Zou Yaqi Wang Zhiyuan Zhang Jing Zhang Miao Mo Changming Zhou Yuan Liu Wenming Zhang Zhaozhen Zhang Yiping He Weiwei Weng Cong Tan Lei Wang Dan Huang Weiqi Sheng Huanhuan Li Hui Zhu Yan Wang Lijun Shen Hui Zhang Juefeng Wan Guichao Li Hua Huang Yanong Wang Zhen Zhang Xiaowen Liu Fan Xia |
| author_facet | Menglong Zhou Wang Yang Yan Xuan Wei Zou Yaqi Wang Zhiyuan Zhang Jing Zhang Miao Mo Changming Zhou Yuan Liu Wenming Zhang Zhaozhen Zhang Yiping He Weiwei Weng Cong Tan Lei Wang Dan Huang Weiqi Sheng Huanhuan Li Hui Zhu Yan Wang Lijun Shen Hui Zhang Juefeng Wan Guichao Li Hua Huang Yanong Wang Zhen Zhang Xiaowen Liu Fan Xia |
| author_sort | Menglong Zhou |
| collection | DOAJ |
| description | Abstract Background Perioperative chemotherapy (ChT) and preoperative chemoradiation (CRT) are both the standard treatments for locally advanced gastric cancer (LAGC). CRT can achieve a higher pathological complete regression (pCR) rate, but whether this higher pCR rate can be transformed into a long-term survival benefit remains inconclusive. Therefore, relevant studies are in progress. On the other hand, immunotherapy has been established for the first-line treatment of advanced gastric cancer (AGC) and has been widely explored in the perioperative setting. The combination of chemotherapy/radiotherapy and immunotherapy may have a synergistic effect, which will lead to a better antitumor effect. The preliminary reports of ongoing studies show promising results, including a further improved pCR rate. However, the preferred treatment combination for LAGC is still not established. To solve this problem, we are carrying out this randomized phase II trial, which aims to evaluate the efficacy and safety of perioperative chemotherapy plus the use of PD-1 antibody with or without preoperative chemoradiation for LAGC. Methods Eligible patients with LAGC or gastroesophageal junction (GEJ) adenocarcinoma were randomized to receive perioperative ChT, PD-1 antibody, surgery with (Arm A) or without preoperative CRT (Arm B), and PD-1 antibody maintenance until one year after surgery. The primary endpoint of this study is that the pCR rate of Arm A will be significantly higher than that of Arm B. The secondary endpoints include the pathological partial regression (pPR) rate, R0 resection rate, objective response rate (ORR), event-free survival (EFS), overall survival (OS), safety and surgical complications. Moreover, several explorative endpoints will be evaluated to find and validate the predictive biomarkers of immunotherapy. Discussion The results of the NeoRacing study will provide important information concerning the application of PD-1 antibody in LAGC patients during the perioperative setting. Meanwhile, the two treatment protocols will be compared in terms of efficacy and safety. Trial registration ClinicalTrials.gov , NCT05161572 . Registered 17 December 2021 - Retrospectively registered. |
| first_indexed | 2024-04-13T15:29:54Z |
| format | Article |
| id | doaj.art-5748f5af758b433e97f86a900f80c0ed |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-13T15:29:54Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj.art-5748f5af758b433e97f86a900f80c0ed2022-12-22T02:41:24ZengBMCBMC Cancer1471-24072022-06-012211910.1186/s12885-022-09786-9A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing studyMenglong Zhou0Wang Yang1Yan Xuan2Wei Zou3Yaqi Wang4Zhiyuan Zhang5Jing Zhang6Miao Mo7Changming Zhou8Yuan Liu9Wenming Zhang10Zhaozhen Zhang11Yiping He12Weiwei Weng13Cong Tan14Lei Wang15Dan Huang16Weiqi Sheng17Huanhuan Li18Hui Zhu19Yan Wang20Lijun Shen21Hui Zhang22Juefeng Wan23Guichao Li24Hua Huang25Yanong Wang26Zhen Zhang27Xiaowen Liu28Fan Xia29Department of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterDepartment of Oncology, Shanghai Medical College, Fudan UniversityDepartment of Radiation Oncology, Fudan University Shanghai Cancer CenterAbstract Background Perioperative chemotherapy (ChT) and preoperative chemoradiation (CRT) are both the standard treatments for locally advanced gastric cancer (LAGC). CRT can achieve a higher pathological complete regression (pCR) rate, but whether this higher pCR rate can be transformed into a long-term survival benefit remains inconclusive. Therefore, relevant studies are in progress. On the other hand, immunotherapy has been established for the first-line treatment of advanced gastric cancer (AGC) and has been widely explored in the perioperative setting. The combination of chemotherapy/radiotherapy and immunotherapy may have a synergistic effect, which will lead to a better antitumor effect. The preliminary reports of ongoing studies show promising results, including a further improved pCR rate. However, the preferred treatment combination for LAGC is still not established. To solve this problem, we are carrying out this randomized phase II trial, which aims to evaluate the efficacy and safety of perioperative chemotherapy plus the use of PD-1 antibody with or without preoperative chemoradiation for LAGC. Methods Eligible patients with LAGC or gastroesophageal junction (GEJ) adenocarcinoma were randomized to receive perioperative ChT, PD-1 antibody, surgery with (Arm A) or without preoperative CRT (Arm B), and PD-1 antibody maintenance until one year after surgery. The primary endpoint of this study is that the pCR rate of Arm A will be significantly higher than that of Arm B. The secondary endpoints include the pathological partial regression (pPR) rate, R0 resection rate, objective response rate (ORR), event-free survival (EFS), overall survival (OS), safety and surgical complications. Moreover, several explorative endpoints will be evaluated to find and validate the predictive biomarkers of immunotherapy. Discussion The results of the NeoRacing study will provide important information concerning the application of PD-1 antibody in LAGC patients during the perioperative setting. Meanwhile, the two treatment protocols will be compared in terms of efficacy and safety. Trial registration ClinicalTrials.gov , NCT05161572 . Registered 17 December 2021 - Retrospectively registered.https://doi.org/10.1186/s12885-022-09786-9Locally advanced gastric cancerGastroesophageal junction adenocarcinomaPreoperative chemoradiationImmunotherapyGastrectomy |
| spellingShingle | Menglong Zhou Wang Yang Yan Xuan Wei Zou Yaqi Wang Zhiyuan Zhang Jing Zhang Miao Mo Changming Zhou Yuan Liu Wenming Zhang Zhaozhen Zhang Yiping He Weiwei Weng Cong Tan Lei Wang Dan Huang Weiqi Sheng Huanhuan Li Hui Zhu Yan Wang Lijun Shen Hui Zhang Juefeng Wan Guichao Li Hua Huang Yanong Wang Zhen Zhang Xiaowen Liu Fan Xia A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study BMC Cancer Locally advanced gastric cancer Gastroesophageal junction adenocarcinoma Preoperative chemoradiation Immunotherapy Gastrectomy |
| title | A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study |
| title_full | A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study |
| title_fullStr | A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study |
| title_full_unstemmed | A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study |
| title_short | A study protocol of a randomized phase II trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma: the NeoRacing study |
| title_sort | study protocol of a randomized phase ii trial of perioperative chemoimmunotherapy verses perioperative chemoimmunotherapy plus preoperative chemoradiation for locally advanced gastric g or gastroesophageal junction gej adenocarcinoma the neoracing study |
| topic | Locally advanced gastric cancer Gastroesophageal junction adenocarcinoma Preoperative chemoradiation Immunotherapy Gastrectomy |
| url | https://doi.org/10.1186/s12885-022-09786-9 |
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