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

NCT04207918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-05-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2022-12-30
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207918 on ClinicalTrials.gov