Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer

The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the second-line therapy for patients diagnosed with HER2-negative unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\

Inclusion Criteria: 1. Metastatic or locally advanced, unresectable HER2-negative gastric adenocarcinoma confirmed by histology or cytology 2. Progression or toxicity intolerance of first-line treatment 3. Patients aged ≥ 18 years 4. ECOG score 0-2 5. Estimated life expectancy of at least 12 weeks 6. Adequate organ and bone marrow function, as follows: Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL,Total bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum albumin≥2.8g/dl, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance \>50mL/min (calculated according to Cockcroft Gault formula) 7. International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) \10mg/ day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy 9. Allergies to investigational drugs or excipients 10. Hypertension that cannot be controlled by antihypertensive drugs, coronary heart disease, heart failure, and arrhythmia (QTcF prolongation,\>450ms in males and\>470ms in females) 11. Severe infection in the 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaOral or intravenous administration of therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, for example, to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease are eligible for study participation) 12. Patients with congenital or acquired immune deficiency (such as HIV infection) 13. Have received live attenuated vaccines within 28 days prior to initiation of study treatment, or are expected to require such vaccines during sintilimab treatment or within 60 days after the last administration of sintilimab