Phase II Study of Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As a Third-line or Later-line Therapy for Patients with Metastatic Gastric Cancer
For patients with metastatic gastric cancer, the efficacy of current standard treatments outlined in the guidelines is far from meeting the clinical demand. This study aims to explore the efficacy and safety of trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab as a novel third-line or later-line therapy for metastatic gastric cancer patients.
• Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
• The clinical stage was IV, according to AJCC 8th edition.
• Patients had received at least two systematic therapies.
• Patients had received or not received immunotherapy.
• The patients received or did not receive anti-VEFGR targeted therapy in the last treatment (e.g., Bevacizumab, Ramucirumab, anti-VEGFR TKIs, etc.).
• Age ≥18.
• ECOG physical status score is 0-2 without deterioration within 2 weeks before the first administration of the investigational drug.
• Adequate organ function according to the following laboratory test values:
‣ Hemoglobin value ≥90g/L.
⁃ White blood cell count ≥3.5\*109/L.
⁃ Absolute neutrophil count ≥1.5\*109/L.
⁃ Platelet count ≥100\*109/L.
⁃ Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
⁃ Total serum bilirubin ≤1.5 upper normal limit (ULN).
⁃ Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).
• With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.