XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study ( FISSION Study )
Gastric cancer is the third leading cause of morbidity and mortality among malignant tumors in China, and less than 30% of patients can be cured by surgery. Liver metastasis, retroperitoneal lymph node metastasis and peritoneal metastasis are the most common metastatic sites of gastric cancer, which are also the important causes of death. Improve the conversion of oligonucleotides transfer patients resection rate, prolonged progression-free survival of these patients, is an important direction to improve survival of patients with advanced gastric cancer; This study was a prospective, single-arm, multi-center clinical study. We plan to treat patients with gastric cancer/gastroesophageal junction adenocarcinoma with liver and/or retroperitoneal lymph node metastasis only with XELOX regimen + fruquinitinib + sintilimab for 4-6 cycles before surgery/ablation conversion therapy to achieve tumor-free status as far as possible. To explore the value of conversion therapy in patients with intrahepatic oligometastasis of gastric cancer.
• Age: 18-75 years of age;
• Understand the steps and content, and written informed consent signed voluntarily;
• Is confirmed by histopathology and/or cytology her2-negative or HER2 status unknown late recurrence or stomach esophagus stomach/integration of adenocarcinoma;
• In this research to define transfer of oligonucleotides definition: the primary lesion and regional lymph node metastasis of process to determine the surgeon can be cut or boundary can be cut, only intrahepatic metastasis and distant metastasis (metastases number 5 or less, a single lesion or less 5 cm in diameter.) And or retroperitoneal lymph node metastasis (16a2,16b1,16a1,16b2 metastasis), no other distant metastasis;
• At least one measurable lesion according to RECIST 1.1 criteria;
• No previous treatment with VEGFR-targeted drugs and PD-1/PD-L1 monoclonal antibodies. Patients who had relapsed more than 6 months after the completion of postoperative adjuvant chemotherapy with platinum or paclitaxel or fluorouracil and had no grade 2 or higher toxicity were eligible for enrollment.
• ECOG PS score: 0-1;
• Expected survival time ≥3 months;
• The main viscera function is good, namely into groups of related within 14 days before check index meet the following requirements:
⁃ (1) hemoglobin ≥80 g/L; (2) neutrophil count \>1.5×109/L; (3) platelet count ≥80×109/L; (4) Total bilirubin ≤2.5×ULN (upper limit of normal); (5) serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5×ULN; (6) the endogenous creatinine clearance or 60 ml/min (Cockcroft - Gault formula); (7) Echocardiography: left ventricular ejection fraction (LVEF)≥50%; (8) Thyroid function indexes: thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) were in the normal range or only mildly abnormal, without related clinical symptoms; (9) A body weight of 40 kg or more, or a BMI \> 18.5;