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Nimotuzumab Combined With Radiotherapy in High-risk Patients With HNSCC Not Suitable for Cisplatin After Surgery

NCT05024019 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2021-08-27

No results posted yet for this study

Summary

This study is a prospective, open label, multicenter, randomized controlled clinical trial. The main purpose of the study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent radiotherapy versus radiotherapy alone in high-risk patients with HNSCC not suitable for cisplatin after surgery. The subjects were randomly divided into study group (nimotuzumab combined with concurrent radiotherapy) and control group (radiotherapy alone) by 1∶1 stratified random method.

Conditions

Interventions

DRUG

Nimotuzumab

The study group received nimotuzumab (200mg, weekly, for 6 weeks) in combination with radiotherapy.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-21
Primary Completion
2025-08-21
Completion
2025-08-21

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT05024019 on ClinicalTrials.gov