The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer.
In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively.
According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period.
This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.
At least 18 years of age, 75 years of age or less, no gender limitation;
Patients with untreated locally advanced resectable adenocarcinoma of the stomach or gastroesophageal junction, with clear pathological diagnosis;
According to RECIST 1.1, the efficacy evaluation standard for solid tumors, there were definite measurable and evaluable lesions, with spiral CT lesions ≥1cm；
Physical condition score KPS score 80-100 points ；
There are distant metastasis or local invasion of adjacent organs；
Tumor recurrence;
Suffered from or had previously suffered from autoimmune diseases;
Past organ transplantation or HIV patients;
Parallel
PD-1 antibody combined with FOLFIRINOX regimen
DrugGive 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。
PD-1 antibody combined with SOX program
DrugGive 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks. 2-4 cycles before surgery. The perioperative period was 8 cycles.
Major pathological response(MPR)
Pathological complete response(pCR)
Disease-free survival(DFS) rate of 3 years
Time to relapse or progression of disease (PD) or death from any cause within 3 years from subject screening to first recorded
Disease-free survival(DFS) rate of 5 years
Time to relapse or progression of disease (PD) or death from any cause within 5 years from subject screening to first recorded
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