Gastric cancer
Conditions
Interventions
Experimental group (Patients with stage III or above gastric adenocarcinoma who cannot achieve R0 resection at the initial stage):Conversion therapy plan: Trastuzumab 200mg, Q3W * 3 cycles combined wi
Postoperative adjuvant plan: R0 resection: XELOX+Q3W treatment with Baize An for six months after surgery
R1 resection: XELOX+Baize An postoperative Q3W treatment for one year
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Gastric adenocarcinoma patients diagnosed by histology or cytology; 2.Male or female, aged 18 to 75 years old; 3.Pathological confirmation shows that stage III or above of the American Joint Committee on Cancer (AJCC) cannot achieve R0 resection for gastric adenocarcinoma; 4.Evaluated by imaging data; 5.The patient has at least one assessable target lesion according to RECIST 1.1 criteria; 6.General Health Status (PS) score 0-1 points; 7.No brain metastasis; 8. Expected survival period >= 6 months 9.Sign informed consent form with good compliance.
Exclusion criteria
Exclusion criteria: 1.Patients who have received anti-PD-1 or anti-PD-L1 treatment in the past; 2. Patients who are currently participating in other clinical studies; 3. Patients with extensive metastasis; 4. Individuals who are allergic to known PD-1 monoclonal antibody drugs and their components; 5. Those who have received other anti-tumor treatments (including steroid hormone therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of treatment; 6. ALT/AST>2.5 times ULN (liver metastasis>5 times ULN), total bilirubin>1.5 times ULN, neutrophils1 * 103 copy number/ml or>200IU/mL) or acute or chronic active hepatitis C (HCV antibody positive); 4) Active pulmonary tuberculosis, etc; 5) Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia; 6) Uncontrolled arterial hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg); 7) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, etc., occurred within the 6 months prior to being selected for treatment; 9. Patients with symptomatic central nervous system metastases and/or cancerous meningitis; 10. Subjects with previous malignant tumors should be excluded unless they have achieved complete remission at least 5 years prior to enrollment in the study and have not undergone any other treatment during the study period; 11. There are unresolvable chemotherapy related toxic reactions of grade 2 or above (excluding grade 2) (according to NCI CTCAE 4th edition); 12. Uncontrollable third interstitial fluid accumulation in clinical practice, such as pleural effusion and ascites that cannot be controlled by drainage or other methods before enrollment; 13. Suffering from active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc; 14. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 15. Major surgical procedures (excluding diagnostic surgical procedures) performed within 4 weeks prior to the start of the study; 16. The researchers believe that patients are not suitable for other situations in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enhanced CT scan of chest, abdomen and pelvis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;Blood biochemical;Blood electrolyte;Complete blood transfusion set;Twelve lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactZhu Chunrong
The First Affiliated Hospital of Soochow University
Outcome results
None listed