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Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc. Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.
Official title: Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2023-03-01
Completion Date
2026-12-31
Last Updated
2024-05-28
Healthy Volunteers
No
Interventions
Nimotuzumab with chemoradiotherapy
Radiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days.
Locations (1)
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China