OncoMatch/Clinical Trials/NCT06091423
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
Is NCT06091423 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies XELOX combined with Fruquintinib and Sintilimab for gastric cancer/gastroesophageal junction adenocarcinoma.
Treatment: XELOX combined with Fruquintinib and Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
her2-negative or HER2 status unknown
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: VEGFR inhibitor
No previous treatment with VEGFR-targeted drugs
Cannot have received: anti-PD-1 therapy
No previous treatment with ... PD-1/PD-L1 monoclonal antibodies
Cannot have received: anti-PD-L1 therapy
No previous treatment with ... PD-1/PD-L1 monoclonal antibodies
Cannot have received: immune-targeted therapy
Previous use of immune-targeted therapy drugs
Lab requirements
Blood counts
hemoglobin ≥80 g/L; neutrophil count >1.5×10^9/L; platelet count ≥80×10^9/L
Kidney function
endogenous creatinine clearance ≥60 ml/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤2.5×ULN; ALT or AST ≤5×ULN
Cardiac function
LVEF ≥50%
(1) hemoglobin ≥80 g/L; (2) neutrophil count >1.5×10^9/L; (3) platelet count ≥80×10^9/L; (4) Total bilirubin ≤2.5×ULN; (5) ALT or AST ≤5×ULN; (6) endogenous creatinine clearance ≥60 ml/min; (7) LVEF ≥50%; (8) TSH and FT3/FT4 in normal range or only mildly abnormal, without related clinical symptoms; (9) body weight ≥40 kg or BMI >18.5
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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