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Recruiting Phase 2 NCT06791083

Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer

Trial Parameters

Condition Gastric Cancer
Sponsor First Affiliated Hospital of Fujian Medical University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-06-20
Completion 2025-12
Interventions
EnvafolimabFruquintinib

Brief Summary

To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma

Eligibility Criteria

Inclusion Criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Aged 18-75 years (including 18 and 75 years); 3. Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0); 4. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, abdominal examination should be performed to rule out distant metastasis. 5. At least 1 measurable lesion according to RECIST v1.1 criteria; 6. United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18; 7. Expected survival ≥12 weeks; 8. The functions of vital organs during the first 14 days of enrollment met the following requirements: * Absolute neutrophil count ≥1.5×109/L; * Platelet ≥80×109/L; * Hemoglobin ≥90g/L; * Total bilirubin \< 1.5 ULN; ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis); * Serum creatinine (Cr) ≤1.5×ULN or creatinine cleara

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