NCT06410651

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy：A Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy 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 and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.

Conditions

• Esophageal Cancer
• Nimotuzumab
• Chemoradiotherapy
• Chemotherapy
• Immunotherapy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-05-13
• Last updated: 2024-05-13

Locations

1 site across 1 country: China