Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab

Inclusion Criteria

• •1. Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
• •2. With or without measurable lesions.
• •3. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• •4. Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
• •5. Life expectancy ≥3 months.
• •6. With normal electrocardiogram results and no history of congestive heart failure.
• •7. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
• •8. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
• •9. With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
• •10. With good compliance and agree to accept follow-up of disease progression and adverse events.