A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer

Inclusion Criteria2

• \- 1. The patients voluntarily participated in the study and signed the informed consent; 2. ≥ 18 years old (calculated on the day of signing informed consent), both male and female; 3. Patients with pathologically confirmed gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who were histologically confirmed to be adenocarcinoma and had not received antineoplastic therapy for GC or GEJC; 4. No prior systemic therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy for GC and GEJC,Radiotherapy or chemoradiotherapy, provided that the last dose of the last drug (based on the last dose) occurred at least 6 months prior to enrollment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before enrollment; 5. Human epidermal growth factor receptor 2 negative or unknown; 6. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1); 7. The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-1. 8. Expected survival > 12 weeks; 9. Adequate organ and bone marrow function, as defined below: A) Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 10 \^ 9/L); B) Platelet count (PLT) ≥ 75,000/mm3 (75 × 10 \^ 9/L); C) hemoglobin (Hb) ≥ 8 G/dL (80 G/L); D) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 ml/min; E) Total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); F) Aspartate transaminase or Alanine transaminase ≤ 2.5 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastasis; G) International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; H) Urine protein < 2 +; if urine protein ≥ 2 +, 24-hour urine protein quantification shows that protein must be ≤ 1 G; I) Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
• Female subjects of childbearing age must have a negative serum pregnancy test within 3 days prior to the start of study medication and be willing to use a medically approved highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) for the duration of the study and for 3 months after the last dose of study medication; Male subjects with a female partner of childbearing age were surgically sterilized or agreed to use an effective method of contraception for the duration of the study and for 3 months after the last study dose.