To evaluate the efficacy and safety of carelizumab combined with XELOX regimen in neoadjuvant treatment of locally advanced resectable gastric cancer
This study is a prospective, single center, single arm clinical study. This study plans to include 67 patients with locally advanced gastric adenocarcinoma who can be operated without any treatment as the study object. After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of karelizumab combined with XELOX regimen for 4 courses of treatment before surgery, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient received radical surgical treatment for gastric cancer, and continued to receive adjuvant treatment of the original scheme after the operation (the first treatment started 6 weeks ± 2 weeks after the operation, and can not exceed 3 months).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Before surgery, the patient received standard dose of carrelizumab combined with XELOX regimen for 4 courses of treatment, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination was conducted to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, and to receive radical hand surgery for gastric cancer
Wang Nan
Xi’an, Shanxi, China
RECRUITINGpCR rate
Pathological remission rate according to Becker standard
Time frame: 7 days after surgery
MPR
major pathologic response according to Becker standard
Time frame: 7 days after surgery
DFS
disease-free survival
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
R0 resection rate
Proportion of R0 level surgery performed
Time frame: postoperative 6 hours
OS
overall survival
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
ORR
Objective remission rate
Time frame: 7 days after surgery
Adverse reactions and perioperative complications (Security)
Adverse reactions and perioperative complications caused by drug therapy
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
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