We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer
The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
Age 18-75 years old (at the time of signing the informed consent), both male and female;
Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
Age 18-75 years old (at the time of signing the informed consent), both male and female;
Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable;
Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy;
Parallel
Proximal radical gastrectomy
Procedure/SurgeryProximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon\'s habit.
Total radical gastrectomy
Procedure/Surgerytotal radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended
3-year Disease-free survival (DFS)
DFS is based on RECIST(Response Evaluation Criteria in Solid Tumours) 1.1 as assessed by the investigator and is defined as the time from surgery initiation to the date of first documentation of disease recurrence or death due to any cause
major pathologic response (MPR)
defined as the percentage of residual viable tumour cells in the tumour bed of no more than 10% after neoadjuvant therapy.
R0 resection rate
defined as the absence of tumor cells present at the resection margin under microscope
Overall Survival (OS)
defined as the time from randomization to death due to any cause.
Percentage of Participants Who Experience One or More Adverse Events (AEs)
An AE is based on NCI-CTC (The National Cancer Institute Common Toxicity Criteria) 5.0 as assessed by the investigator and is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.
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Guihua Wang
Lead sponsor
Tongji Hospital
Sponsor institution
Fudan University
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Xiangya Hospital of Central South University
Collaborator
Shandong First Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The First Medical Center of Chinese PLA General Hospital
Collaborator
Affiliated Hospital of Qinghai University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Ruijin Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Southern Medical University, China
Collaborator
Shanxi Bethune Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Jingzhou Central Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
The First Affiliated Hospital of University of South China
Collaborator
Guangdong Provincial People's Hospital
Collaborator
People's Hospital of Macheng City
Collaborator
Southwest Hospital, China
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
RenJi Hospital
Collaborator
Changhai Hospital
Collaborator
The First Affilated Hospital of the Medical College, Shihezi University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
First Hospital of China Medical University
Collaborator
Shanghai East Hospital
Collaborator
General Hospital of Ningxia Medical University
Collaborator
Shanghai Changzheng Hospital
Collaborator
