Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric … (NCT06888037) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer
China55 participantsStarted 2025-03-31
Plain-language summary
This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Voluntarily signed the informed consent and had good compliance;
* Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;
* Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
* He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;
* Patients with disease progression/relapse occurring more than 6 months after completion of neoadjuvant/adjuvant therapy;
* At least one measurable lesion according to RECIST version 1.1;
* Tumor tissue/serum samples were tested as microsatellite stable (MSS) or mismatch repair intact (pMMR), HER2 negative;
* Adequate organ functions:
Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥3×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN (If liver metastasis, AST and ALT≤5 XULN); Serum creatinine (Cr) ≤1.5XULN or serum creatinine clearance ≥50 ml/min; Urinary protein ≤2+, or 24-hour urinary protein volume ≤2000mg; Prothrombin time (PT) and partially activated prothrombin time (APTT) ≤1.5×ULN;
• Female or male patients of reproductive age must use effective contraception throughout and for 6 months after treatment.
Exclusion Criteria:
* Participated in other drug clinical trials within 4 weeks before enrollment;
* Have had other malignancies …