OncoMatch/Clinical Trials/NCT05721651
Efficacy and Safety of Fruquintinib in Combination With PD-1 Inhibitors as First-line Maintenance Therapy for Advanced HER-2 Negative Gastric Cancer: a Single-arm, Prospective, Exploratory Clinical Study
Is NCT05721651 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fruquintinib+PD-1 for gastric cancer.
Treatment: Fruquintinib+PD-1 — Maintenance therapy is very important in advanced HER-2 negative gastric cancer, and immune monotherapy has no obvious benefit in the first-line maintenance treatment of advanced gastric cancer； Fruquintinib is a potent small-molecule VEGFR inhibitor with high kinase selectivity；Studies have shown that immunotherapy combined with antiangiogenic agents is promising for synergistic antitumor effects； The aim of this study was to observe and evaluate the efficacy and safety of Fruquintinib combined with PD-1 inhibitor in the first-line maintenance treatment of advanced HER-2 negative gastric cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
Disease stage
Metastatic disease required
with extragastric measurable lesions (RECIST 1.1 criteria)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy (nivolumab, sindilizumab, tirelizumab) — first-line
received first-line PD-1 inhibitors (nivolumab/sindilizumab/tirelizumab) combined with standard chemotherapy and were assessed as non-PD according to RECIST 1.1 criteria
Must have received: chemotherapy (SOX, FOLFOX, CAPEOX, fluorouracil combined with purple shirt, single-agent chemotherapy) — first-line
Chemotherapy regimen: SOX/FOLFOX/CAPEOX or fluorouracil combined with purple shirt; Patients receiving single-agent chemotherapy were allowed to enroll; Chemotherapy regimens are used for 4-8 cycles
Cannot have received: antiangiogenic therapy (bevacizumab, apatinib, anlotinib, lenvatinib)
Previous use of antiangiogenic drugs, such as bevacizumab, apatinib, anlotinib, lenvatinib and other antiangiogenic drugs
Cannot have received: immune checkpoint inhibitor
Exception: more than one
Previous treatment with more than one immune checkpoint inhibitor
Lab requirements
Blood counts
Hemoglobin ≥90 g/L; ANC ≥1.5×10^9/L; Platelet ≥100×10^9/L
Kidney function
Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 ml/min
Liver function
Total bilirubin (TBIL) ≤1.5x ULN, or ≤2.5x ULN in the case of liver metastasis; ALT and AST ≤2.5x ULN, or ≤5x ULN with liver metastasis
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%)
Major organ function within 7 days before treatment meets the following criteria: (1) hemoglobin (HB) ≥90 g/L; (2) Absolute neutrophil ANC ≥1.5×10^9/L; (3) Platelet (PLT) ≥100×10^9/L; Biochemical tests: (1) TBIL ≤1.5x ULN, or ≤2.5x ULN in the case of liver metastasis (2) ALT and AST ≤2.5x ULN, or ≤5x ULN with liver metastasis (3) Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 ml/min; Doppler ultrasound: LVEF ≥ lower limit of normal (50%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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