Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborator: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. T3-4NxM0 locally advanced gastric or gastroesophageal junction carcinoma was confirmed by gastroscopic biopsy, CT and pathological examination;

2. o previous systematic treatment for the current disease;

3. Age ≥ 70 years, age ≥18 years, both sexes;

4. ECOG physical status score 0-1; Full organ and bone marrow function:

5. 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.

6. Not receiving blood transfusion, blood products, or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks;

7. Sign an informed consent form before starting the study on a specific screening procedure;

8. The estimated survival time is more than 3 months;

9. 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:

1. People with allergic disease, history of severe drug allergy, known allergy to macromolecular protein preparations or carrelizumab;

2. Early gastric cancer;

3. Gastric cancer patients with HER2 amplification by pathological gene detection;

4. 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);

5. The presence or history of any active autoimmune disease (including but not limited to: interstitial pneumonia, Uveitis, enteritis, nephritis, hyperthyroidism, hypothyroidism);

6. You are using immunosuppressive agents or hormone therapy (systemic or topical) to achieve immunosuppression, and Continued to use within 2 weeks before enrollment;

7. Severe infection (if intravenous antibiotics, antifungal or antiviral drugs are needed);

8. Congenital or acquired immune deficiency (such as HIV-infected persons), or active hepatitis ((with regular antiviral treatment)