The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ,the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
Neoadjuvant chemotherapy and neoadjuvant radiotherapy and chemotherapy can not only improve the surgical resection rate and postoperative pathological remission rate, but also prolong the postoperative recurrence-free survival and benefit patients.Recent studies have confirmed that immume point inhibitors PD-1 and CTLA-4 monoclonal antibody have a certain effect in advanced gastric and gastroesophageal junction adenocarcinoma which had experienced multi-line treatment. Furthermore,the FOLFOX protocol is recommended as a new adjuvant treatment for locally advanced gastric cancer.In order to further improve the surgical resection rate and survival rate by improving the efficacy of neoadjuvant therapy for locally advanced gastric and gastroesophageal junction adenocarcinoma, the investigators selected PD-1 monoclonal antibody combined with FOLFOX neoadjuvant therapy for locally advanced gastric and gastroesophageal junctions Adenocarcinoma.The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ,the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
1. SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days. 2. FOLFOX: Oxaliplatin 85mg/m2 ivgtt 2h d1; 5-fluorouracil 400mg/m2 iv d1; leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2400mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication.
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
R0 resection rate
The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins.
Time frame: Up to approximately 16 weeks
pathological complete response (pCR) rate
The percentage of patients with no residual cancer cells at the primary cancer site and N(-) per histological evaluation.
Time frame: Up to approximately 16 weeks
Near pathological complete response (near-pCR) rate
Near-pCR rate is defined as the percentage of patients with grade 0-1 tumors per NCCN tumor regression grading (TRG).
Time frame: Up to approximately 16 weeks
Overall survival(OS)
OS is defined as the time from the first dose to all-cause death.
Time frame: From randomization to the date of death (up to approximately 4 years)
Progression-free survival(PFS)
PFS is defined as the time from the first dose to objective disease progression or death.
Time frame: up to 2 years
Disease-free survival (DFS)
DFS is defined as the time from the postoperative baseline imaging evaluation to disease recurrence or death in subjects who are disease-free after surgery.
Time frame: From randomization to the date of recurrence or death (up to approximately 4 years)
Percentage of Participants Who Experience One or More Adverse Events (AEs)
The incidence and grade of adverse events (including serious adverse events and immune-related adverse events) will be determined per NCI-CTCAE 4.0.
Time frame: up to approximately 1 years
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