Gastric cancer
Conditions
Interventions
singel arm:neoadjuvant chemotherapy with sindilizumab
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Age of 18 years old or more; 2)The PD - L1 positive (>=1%); 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4)The histologically confirmed gastric adenocarcinoma/gastroesophageal junction adenocarcinoma has not been treated with prior surgery or anti-tumor chemoradiotherapy/immunotherapy; 5)Confirmed to locally advanced adenocarcinoma according to the 8th edition of AJCC,cT3-4 N+ M0 was diagnosed by endoscopic ultrasonography or enhanced CT/MRI cTNM, and the lesion was resectable; 6) Preoperative laparoscopic examination confirmed P0 and CY0; 7)During the trial, contraception was used; 8)Major organ function has to meet the following certeria: HB >= 90g/L; ANC >= 1.5x10^9/L; PLT >= 90x10^9/L; ALT and AST = 30g/ LINR /PT <= 1.5x ULNaPTT <= 1.5x ULN; 9)Signed informed consent, no other surgical contraindications, and agreed to provide blood samples and histological specimens; 10)According to RECIST v1.1, there was at least one measurable lesion.
Exclusion criteria
Exclusion criteria: 1)Pregnant or nursing women. 2)Women of child-bearing age were positive on the baseline pregnancy test. 3)Distant metastases diagnosed by CT /MR/ EUS. 4)Received prior antitumor therapy, including chemotherapy, radiation, targeted therapy or immunotherapy. 5)Other malignancies in the past 5 years (except basal or squamous cell carcinoma, superficial bladder cancer, in-situ cervical cancer or breast cancer). 6)Uncontrolled pleural effusion, pericardial effusion, or ascites. 7)Severe cardiovascular disease, such as symptomatic coronary heart disease, grade II congestive heart failure, uncontrolled arrhythmias, and myocardial infarction, occurred within 12 months prior to enrollment. 8)Complications include upper gastrointestinal obstruction/bleeding or digestive dysfunction or malabsorption syndrome. 9)Complicated by severe uncontrolled infection or other serious uncontrolled concomitant disease, moderate or severe renal injury. 10)Allergic reactions to the medication used in this study. 11)Received steroids or other systemic immunosuppressive therapy 14 days prior to enrollment. 12)Receive study drug therapy within 4 weeks prior to enrollment (participating in other clinical trials). 13)Active autoimmune disease. 14)History of primary immunodeficiency. 15)Immunosuppressive agents were used within 4 weeks prior to the initial study treatment, excluding topical corticosteroids by nasal spray, inhalation, or other means, or systemic glucocorticoids in physiological doses (less 10mg/ day or equivalent of other glucocorticoids), or hormones for the prevention of contrast agent allergy. 16)Receive the live attenuated vaccine within 4 weeks prior to the first dose of the study treatment or plan to receive the live attenuated vaccine during the study period. 17)Have active tuberculosis. 18)History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 19)HIV antibody positive, active hepatitis b or c (HBV, HCV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival (PFS) of 3years Type;R0-resection rate;Overall survival (OS) of 3years;surgical complication; | — |
Countries
China
Contacts
Public ContactQun Zhao
The Fourth Hospital of Hebei Medical University
Outcome results
None listed