Cancer of the stomach
Conditions
Interventions
Queue 1:Apatinib mesylate + carririzumab + capetabine + oxaliplatin
Queue 2:Apatinib mesylate + capetabine + oxaliplatin
Sponsors
Tangdu Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, both male and female; 2. Patients with resectable gastric cancer confirmed by histopathology or cytology; 3. Subjects with ECoG score of 0-1; 4. >= 1 measurable disease baseline was based on the response assessment criteria of solid tumors, version 1.1 (RECIST v1.1); 5. The subjects must have enough physical condition to be used for the expected resection of gastric cancer; 6. If the expected survival time of the subjects with normal main organ function is more than 3 months, they meet the following criteria: (1) Blood routine examination should meet the following requirements (no blood transfusion within 14 days, no use of hematopoietic factors and no use of drugs for correction) ANC >= 1.5 x 10^9/L HB >= 90 g/L PLT >= 50 x 10^9/L (2) Biochemical examination: (no albumin transfusion within 14 days before screening) Serum albumin >= 29 g / L; Serum total bilirubin 50 ml / min (Cockcroft Gault formula is as follows) Male: Cr clearance rate = ((140 age) x body weight) / (72 x blood CR) Female: Cr clearance rate = ((140 age) x body weight) / (72 x blood CR) x 0.85 Body weight unit: kg; blood CR unit: mg / ml; (3) The international normalized ratio (INR) = 2 +, 24-hour (H) urinary protein quantification can be performed, and 24-hour urinary protein quantification < 1.0 g can be included in the group). 6. Fertile women: they must agree to abstain (avoid heterosexual intercourse) or use reliable and effective contraceptive methods from signing the informed consent form until at least 120 days after the last administration of the study drug; 7. The patients who voluntarily joined the study signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with uncontrolled or symptomatic active central nervous system (CNS) metastasis may present with clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth; 2. Subjects with pleural effusion, ascites or pericardial effusion that could not be controlled by effective treatment within 7 days before enrollment; 3. Subjects who received the following treatments or drugs before enrollment: (1) Major surgery was performed within 28 days before enrollment (biopsy and peripherally inserted central catheter (PICC) for diagnosis were allowed). (2) Immunosuppressive drugs were used within 7 days before enrollment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg / D prednisone or other corticosteroids of the same pharmacophysiological dose). (3) Live attenuated vaccine was inoculated within 28 days before enrollment or within 60 days after the end of study drug treatment; 4. Patients who had been diagnosed with any other malignant tumor within 3 years before entering the study, except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid carcinoma, can receive local treatment and have been cured; 5. Patients with any active, known or suspected autoimmune diseases. Subjects in stable state without systemic immunosuppressive therapy, such as type I diabetes, hypothyroidism requiring hormone replacement therapy only, and skin diseases without systemic therapy (such as vitiligo, psoriasis, and alopecia) were allowed to be included; 6. Patients who have previously received anti-PD-1 / PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or other drugs / antibodies acting on T cell costimulation or checkpoint pathway; 7. Patients with significant clinical significance of gastrointestinal bleeding within 3 months before enrollment; patients with gastrointestinal perforation and / or gastrointestinal fistula within 6 months before enrollment; 8. Patients with clinically significant intestinal obstruction; 9. Patients who are known to be allergic to the study drug or any of its excipients; or have had severe allergic reactions to other monoclonal antibodies; 10. Patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmia and symptomatic congestive heart failure within 6 months before enrollment; 11. Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); 12. Systemic use of antibiotics for more than 7 days within 4 weeks before enrollment, or fever of unknown origin > 38.5 degrees C during screening period / before the first administration (according to the judgment of researchers, fever caused by tumor can be enrolled); 13. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Patients with other serious physical or mental disorders or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, and patients who are considered unsuitable by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathology rate;Objective response rate;Disease free survival;Overall surviva;Security; | — |
Countries
China
Contacts
Public ContactNan Wang
Tangdu Hospital of Air Force Medical University
Outcome results
None listed