Gatric cancer
Conditions
Interventions
Experimental group:Carrilizumab, Aptinib, S-1 and Oxaliplatin
Control group1:Carrilizumab, S-1 and Oxalipla
Control group2:S-1 and Oxalipla
Sponsors
Shandong Provincial Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years male and female; 2. In patients with critical resectable gastric cancer diagnosed by histopathology, T4b or N3 lymph nodes metastasized or fused into clusters of lymph nodes 3. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 5. Life expectancy of at least 3 months 6. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up. 7. Patients must have adequate organ function; 8. Pre-resection of tumor tissue is availablet
Exclusion criteria
Exclusion criteria: 1. BMI = 10% within 2 months before screening (while considering the effect of a large amount of ascites on body weight). 2. History of gastrointestinal perforation and/ or hypotube within 6 months prior to first dose. 3. Allergy to the drugs in this protocol including Carrilizumab, oxaliplatinum, Tegafur and apatinib. 4. Have received any of the following treatments: a. Have previously received anti-PD-1 or anti-PD-L1 antibody therapy; b. Have received any research drug within 4 weeks before the first use of the drug; c. Currently participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or an interventional clinical study follow-up; d. Received the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks of the first dose of study medication.; e. Concurrent medical condition requiring the use of cortisol ( > 10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment; f. Received a live vaccine or anticancer vaccine within 4 weeks of the first dose of study medication; g. Received major surgery or trauma within 4 weeks before first use of study drug. 5. not recovered from previous anti-tumor treatment toxicity to CTCAE1 level (except for hair loss). 6. Subjects with any active autoimmune disease or history of autoimmune disease except for patients with vitiligo or cured childhood asthma / allergies who do not need any intervention in adults; autoimmune thyroid cancer received with a stable dose of thyroid replacement hormone therapy Hypofunction, using a stable dose of insulin for type I diabetes. 7. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and a history of allogeneic bone marrow transplantation. 8. Uncontrolled clinically significant cardiovascular clinical symptoms or diseases. 9. Severe infection (CTCAE> grade 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; baseline chest imaging examination showed active pulmonary inflammation; 2 weeks before the first use of the study drug, signs and symptoms of infection or need oral and intravenous antibiotics, except for prophylactic antibiotics. 10. Have a history of interstitial lung disease (except for radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia. 11. Subjects with active tuberculosis infection by medical history or CT examination, or subjects with active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis interference but without formal treatment more than 1 year ago. 12. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);disease-free survival rate (DFS, 2years);pathological complete remission (pCR rate); | — |
Countries
China
Contacts
Public ContactLeping Li
Shandong Provincial Hosptial
Outcome results
None listed