gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:Carrizumab + docetaxel + oxaliplatin + calcium folinate + fluorouracil
Control group:docetaxel + oxaliplatin + calcium folinate + fluorouracil
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years male and female; 2. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology; 3. Patients with cT3-4aN+M0 or cT4bNanyM0 without resectable factors; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 5. Life expectancy of at least 12 weeks; 6. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up; 7. The function of important organs shall meet the following requirements (Within 14 days before the first use of the study drug, it is not allowed to use any blood component, cell growth factor, drug for increasing leukocyte, drug for increasing platelet and drug for correcting anemia); (1) neutrophil absolute count (ANC) >=1.5*10^9/L; (2) platelets >=100*10^9/L; (3) hemoglobin >=9g/dl; (4) serum albumin >=2.8g/dl; (5) total bilirubin 60ml/min; (7) APTT and INR <=1.5 ULN; 8. The ejection fraction in echocardiography before treatment was more than 50%; 9. No history of surgical resection; 10. Laparoscopic exclusion of peritoneal metastasis (if clinically suspected); 11. Willing to provide tumor tissue at baseline and during surgery.
Exclusion criteria
Exclusion criteria: 1. All primary unresectable stages; 2. Recurrent patients; 3. BMI = 10% within 2 months before screening (while considering the effect of a large amount of ascites on body weight); 4. History of gastrointestinal perforation and/ or hypotube within 6 months prior to first dose; 5. Allergy to any components or drugs in this protocol including monoclonal antibody shr-1210, docetaxel, oxaliplatin and fluorouracil; 6. Contraindications to any component of monoclonal antibody shr-1210, docetaxel, oxaliplatin and fluorouracil; 7. Have received any of the following treatments: (1) Have previously received anti-PD-1 or anti-PD-L1 antibody therapy; (2) Have received any research drug within 4 weeks before the first use of the drug; (3) 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; (4) 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; (5) Received a live vaccine or anticancer vaccine within 4 weeks of the first dose of study medication; (6) Received major surgery or trauma within 4 weeks before first use of study drug; 8. 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; 9. 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; 10. Uncontrolled clinically significant cardiovascular clinical symptoms or diseases; 11. 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; 12. 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; 13. 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; 14. Peripheral neuropathy > NCI grad II; 15. Pregnant or lactating women; 16. Chronic gastrointestinal diseases; 17. Other conditions that the researchers think do not conform to the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete remission (pCR rate);R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);progression-free survival rate;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZimin Liu
The Affiliated Hospital of Qingdao University
Outcome results
None listed