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The Effect of Nitozumab in the Treatment of Head and Neck Squamous Cell Carcinoma

NCT05831930 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-04-26

No results posted yet for this study

Summary

For patients with locally advanced head and neck tumors who are over 70 years old, have PS\>2, have hearing impairment, renal dysfunction, or have neuropathy greater than grade 1 that is intolerant to cisplatin, radiotherapy alone or combined with EGFR monoclonal antibody radiotherapy should be chosen. The purpose of this study is to demonstrate the superior efficacy of Nitozumab and Sinilimab when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently.

Conditions

  • HNSCC

Interventions

DRUG

Nituozumab

Nituozumab injection 200mg, administered once a week on the first day, with a duration of at least 60 minutes for a total of 7 times

Sponsors & Collaborators

  • Sichuan Cancer Hospital and Research Institute

    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
2023-01-17
Primary Completion
2026-01-31
Completion
2026-01-31

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 NCT05831930 on ClinicalTrials.gov