NCT04207918

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

Conditions

• Esophageal Cancer
• Chemoradiotherapy
• Nimotuzumab
• Unresectable Malignant Neoplasm

Interventions

Type	Name	Description
RADIATION	Radiotherapy	44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.
DRUG	Nimotuzumab	400mg, by intravenous infusion once a week in 4-6 weeks.
DRUG	S-1	40-60mg/m2/d，orally twice a day concurrently with radiotherapy.

Timeline

• Start date: 2019-11-14
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2019-12-23
• Last updated: 2024-05-16

Locations

1 site across 1 country: China