Actively Recruiting
Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
Led by Shandong Cancer Hospital and Institute · Updated on 2026-01-12
335
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC) who cannot receive platinum-based chemotherapy. This international, open-label, randomized Phase III study compares radiotherapy combined with nimotuzumab to radiotherapy alone. The goal is to assess the safety and effectiveness of adding nimotuzumab to radiotherapy in this specific group of patients. Participants receive radiotherapy using an intensity-modulated technique, either photon IMRT or proton IMPT, delivering a total dose of 70 Gy over 35 fractions, five times a week. In one group, nimotuzumab is given as a 200 mg intravenous injection once weekly for seven weeks during radiotherapy. The other group receives only the radiotherapy treatment. This study is conducted across about 70 sites worldwide. During the study, participants will be followed for at least 24 months after treatment starts. Researchers will monitor progression-free survival as the primary outcome. Secondary outcomes include locoregional control, distant metastasis rate, overall survival, tumor response, and quality of life. Participants will undergo evaluations and assessments throughout the study to track these outcomes and any safety concerns.
CONDITIONS
Brief Title
Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed stage III-IVB head and neck squamous cell carcinoma
- Unsuitable for surgical treatment due to patient condition, tumor factors, or medical reasons
- Suitable for definitive radiotherapy with curative intent
- Unsuitable for cisplatin-based chemotherapy due to age, ECOG status, renal dysfunction, severe hearing loss, peripheral neuropathy, or other comorbidities
- Provide tumor tissue for EGFR testing; for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible
- ECOG Performance Status 0-1 or Karnofsky Performance Status 80 or higher
- At least one measurable lesion per RECIST 1.1
- Expected survival of at least 6 months
- Adequate hematologic, renal, and liver function as defined in the protocol
- Voluntary participation with signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Received PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment
- Participated in another interventional clinical trial within 30 days prior to screening
- History of other malignancy except cured basal cell carcinoma of the skin
- History of primary immunodeficiency
- Uncontrolled comorbid conditions such as severe heart, lung, liver disease, or psychiatric illness
- Known HIV infection, active viral hepatitis, or active tuberculosis
- Major surgery within 90 days before first study treatment or planned surgery during study
- Known allergy to nimotuzumab or its excipients
- Deemed unsuitable by investigator
- Unwilling or unable to sign informed consent
- Received a live vaccine within 30 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks concurrent with radiotherapy (35 fractions over 7 weeks)
Participants receive radiotherapy with or without nimotuzumab as part of their treatment for locoregionally advanced head and neck squamous cell carcinoma.
Weekly visits for nimotuzumab infusions and daily radiotherapy sessions (5 fractions per week for 7 weeks)
Duration - Up to 24 months after treatment initiation
Participants are monitored for disease progression, survival, and quality of life for up to 24 months after treatment initiation.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Cancer Hospital
Shandong, Province, China
Actively Recruiting
Research Team
M
Man Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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