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
Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosis.At present, neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response (pCR) rate, reduce the clinical stage of tumors and improve the resection rate of radical surgery.Some studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacy.Proximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes, which may contribute to long-term survival and improve postoperative quality of life of patients. It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival (OS) rate.At the same time, our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -(L)1 immunotherapy, which is expected to be further confirmed in this clinical trial.Therefore, we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer, which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
404
Proximal 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 : 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
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITING3-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
Time frame: UP to 3 years after surgery
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.
Time frame: an average of 2 to 4 weeks after surgery
R0 resection rate
defined as the absence of tumor cells present at the resection margin under microscope
Time frame: an average of 2 to 4 weeks after surgery
Overall Survival (OS)
defined as the time from randomization to death due to any cause.
Time frame: UP to 5 years after surgery
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.
Time frame: Up to approximately 36 months
nutritional status
Nutrition was assessed with the patient-generated subjective global assessment (PG-SGA).
Time frame: UP to 3 years after surgery
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quality of life
Questionnaire includes EORTC QLQ-C30 (The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30))(version 3),
Time frame: UP to 3 years after surgery