Advanced unresectable gastric cancer
Conditions
Interventions
experimental group:carrelizumab injection combined with dual chemotherapy (S-1/albumin paclitaxel) and/or apatinib
Sponsors
The First Affiliated Hospital of PLA Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as gastric adenocarcinoma by gastroscopy and pathology; 2. Patients aged 18-70 years; 3. Patients with life expectancy >= 3 months; 4. Unresectable patients in newly diagnosed advanced stage without previous anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.); 5. Subjects with ECoG score of 0-2; 6. Preoperative CT or MRI, PET-CT examination showed that there was one unresectable factor; 7. Patients with N3 lymph node metastasis (N3) mainly refer to group 16 (N3 lymphatic metastasis); 8. Extensive or bulky lymph nodes 9. Subjects with local progression of T4b; 10. Hepatic metastases (H1): = 1.5 * 10^9 / L; platelet count (PLT) >= 100 * 10^9 / L; hemoglobin content (Hgb) >= 9.0 g / dl. 20. The patients with normal liver function (ALT <= 2.5 * ULN) were not required. The patients with liver metastasis required: serum total bilirubin (TBIL) <= 1.5 * upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 5 * ULN. 21. Renal function: creatinine clearance rate (CCR) = 50 ml / min (calculated by Cockcroft / Gault formula). 22. Subjects with sufficient coagulation function were defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 fold ULN; if the subjects were receiving anticoagulant therapy, as long as Pt was within the prescribed range of anticoagulant drugs.
Exclusion criteria
Exclusion criteria: 1. Subjects with distant metastasis of lung, brain, bone, etc. except for the oligometastasis defined in the inclusion criteria. 2. Patients with HER-2 positive and willing to accept Herceptin. 3. Subjects with known endoscopic signs of active bleeding. 4. The obstruction of cardia and pylorus affects the patient's eating and gastric emptying, or the swallowing of tablets is obstructed. 5. Patients with other uncontrollable serious diseases (severe uncontrolled recurrent infection, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, uncontrollable hypertension, renal insufficiency, peripheral neuropathy with symptoms, NCI grade > grade II, etc.). 6. Subjects who had received other drug treatment before enrollment or who could not guarantee to carry out the research according to the research requirements after enrollment. 7. Subjects who are allergic to the drugs in this program; pregnant or lactating women or women of childbearing age who are pregnant without contraception. 8. Recipients who need immunosuppressive therapy for organ transplantation. 9. Patients without self-knowledge and mental disorders. 10. Subjects who received systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks before the first administration. 11. Subjects who had used immunosuppressive drugs within 4 weeks before the first dose of study treatment were excluded from nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (i.e. no more than 10 mg / day prednisone or equivalent doses of other glucocorticoids), or hormones used to prevent allergy to contrast media. 12. Subjects who received live attenuated vaccine within 4 weeks before the first dose of study treatment or planned to receive live attenuated vaccine during the study. Note: it is allowed to receive inactivated vaccine for seasonal influenza injection within 4 weeks before the first administration, but it is not allowed to receive live attenuated influenza vaccine. 13. Subjects with active, known or suspected autoimmune diseases or a history of the disease in the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease who do not need systematic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy, and type I diabetes who only need insulin replacement therapy can be enrolled). 14. Patients with known history of primary immunodeficiency. 15. Patients known to have active tuberculosis. 16. Patients with known history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 conversion; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;R0 resection rate;OS;PFS; | — |
Countries
China
Contacts
Public ContactJi Gang
The First Affiliated Hospital of PLA Air Force Medical University
Outcome results
None listed