Actively Recruiting
Compare 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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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),
CONDITIONS
Official 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 (oral cavity, oropharynx, hypopharynx, larynx)
- Unsuitable for surgical treatment due to patient condition, tumor factors, or medical reasons
- Suitable for definitive curative radiotherapy
- At least one reason for being unable to receive cisplatin-based chemotherapy, including age 65 or older with intolerance, ECOG performance status above 2, renal dysfunction (creatinine clearance under 50 mL/min), severe hearing loss, peripheral neuropathy above Grade 1, or inability to receive intravenous hydration
- Willing to provide tumor tissue for EGFR testing and HPV/p16 testing for oropharyngeal cancer if possible
- ECOG performance status of 0-1 or Karnofsky performance status 80 or above
- At least one measurable lesion based on RECIST 1.1 criteria
- Expected survival of 6 months or more
- Adequate blood counts (WBC ≥4x10^9/L, neutrophils ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥90 g/L)
- Adequate kidney function (serum creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥60 mL/min)
- Adequate liver function (total bilirubin ≤1.5 times upper limit of normal; AST and ALT ≤2.5 times upper limit of normal)
- Voluntary signed informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- Receipt of PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks before enrollment
- Participation in another clinical trial within 30 days before screening
- History of other cancers except cured basal cell carcinoma of the skin
- History of primary immunodeficiency
- Uncontrolled serious illnesses such as heart failure, severe lung or liver disease, or psychiatric illness
- Known HIV infection, active viral hepatitis, or active tuberculosis
- Major surgery within 90 days before starting study treatment or planned surgery during the study
- Known allergy to nimotuzumab or its ingredients
- Investigator's judgment that participation is unsuitable
- Unwillingness or inability to provide informed consent
- Receipt of a live vaccine within 30 days before the first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Cancer Hospital
Shandong, Province, China
Actively Recruiting
Research Team
M
Man Hu
CONTACT
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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