PD-1 Antibody Sintilimab Combined With Modified FLOT Regimen in the Treatment of Metastatic Gastric Cancer: a Phase II Clinical Study
This is a prospective, one-arm, single-center phase II study. The objective was to evaluate the efficacy and safety of domestic PD-1 antibody Sintilimab combined with modified FLOT regimen in the treatment of metastatic gastric cancer. To compare the time of maintenance of treatment after induction of chemotherapy with sintilimab combined with modified FLOT regimen until the reapplication of induction regimen with or without the combination of sintilimab, and the time of secondary progression after signing informed consent until the reapplication of induction regimen with or without the combination of sintilimab.
• Aged ≥18 years and men or women
• With histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, local lesions that cannot be radically resected, or metastatic gastric cancer
• For treatment-naïve patients, or postoperative recurrence at least 6 months from the last adjuvant chemotherapy
• With Eastern Cooperative Oncology Group (ECOG) PS of 0-1
• With a life expectancy of more than 3 months
• Who obtain the following laboratory test data within 7 days (including the seventh day) prior to the study screening: neutrophil count of ≥1.5 × 10\^9/L, platelet count of ≥100 × 10\^9/L, hemoglobin level of ≥90 g/L, serum total bilirubin of ≤1.25 the upper limit of normal (ULN); ALT and AST levels of ≤2.5 × ULN (≤5 × ULN for patients with liver metastasis); serum creatinine level of ≤1.0 × ULN and creatinine clearance of ≥50 ml/min; International Normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; If the subject is receiving anticoagulant therapy, PT should be within the prescribed anticoagulant range.
• With at least one extragastric measurable lesion (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria)
• Patients (or their legal representative/guardian) must sign an informed consent form indicating that they understand the purpose of the study, understand the procedures necessary for the study, and are willing to participate in the study.