Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer
Locally Advanced Gastric Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination;
- No previous systematic treatment for the current disease;
- Age ≥ 70 years, age ≥18 years, both sexes;
- ECOG physical status score 0-1; Full organ and bone marrow function:
Blood routine: hemoglobin ≥90g/L, neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L; Liver function: serum total bilirubin ≤1.5× upper normal value (UNL), aspartate transferase ≤3×UNL, alanine Acid transferase ≤3×UNL; Renal function: serum creatinine ≤1.5×UNL, creatinine clearance rate ≥50ml/min; Coagulation function: INR, APTT and PT ≤1.5×UNL; Serum albumin ≥30g/L; Thyrotropin (TSH) and free thyroxine (fT4) were within the range of normal ±10%.
Electrocardiogram showed no obvious abnormality.
- Not receiving blood transfusion, blood products, or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks;
- Sign an informed consent form before starting the study on a specific screening procedure;
- The estimated survival time is more than 3 months;
- Subjects volunteered to join this study, with good compliance, safety and survival follow-up -
Exclusion Criteria:
Patients with any of the following were excluded from the study:
- People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab;
- Early gastric cancer;
- Gastric cancer patients with HER2 amplification by pathological gene detection;
- History of other malignancies (except cured basal cell carcinoma of the skin, cured cervix) with disease-free survival <5 years Carcinoma in situ and gastrointestinal neoplasms proven to be cured by endoscopic mucosal resection);
- The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism);
- You are using immunosuppressive agents or hormone therapy (systemic or topical) to achieve immunosuppression, and Continued to use within 2 weeks before enrollment;
- Severe infection (if intravenous antibiotics, antifungal or antiviral drugs are needed);
- Congenital or acquired immune deficiency (such as HIV-infected persons), or active hepatitis ((with regular antiviral treatment)
Sites / Locations
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
Camrelizumab + SOX / XELOX