RecruitingPhase 3NCT07333274

Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

335 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing radiation therapy plus nimotuzumab (a targeted antibody drug) against radiation therapy alone for patients with locally advanced head and neck cancer who cannot receive standard platinum-based chemotherapy (usually cisplatin) due to their health. **You may be eligible if...** - You are 18 or older with confirmed stage III–IVB head and neck squamous cell cancer (mouth, throat, voice box, or lower throat) - Surgery is not an option for you - You are not able to tolerate cisplatin chemotherapy (e.g., due to age 65+, kidney problems, hearing loss, nerve damage, or poor performance status) - You are suitable for definitive (curative-intent) radiation therapy **You may NOT be eligible if...** - You are able to receive standard cisplatin chemotherapy - Your cancer has spread to distant organs (stage IVC, if not eligible for the study criteria) - You have had prior radiation, chemotherapy, or other cancer treatment for this tumor - You have significant heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNimotuzumab

Treatment regimen: Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).

RADIATIONintensity-modulated technique(IMRT)

Treatment regimen: Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.


Locations(1)

Shandong First Medical University Affiliated Cancer Hospital

Shandong, Province, China

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NCT07333274


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