Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
Nimotuzumab: Treatment regimen: Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).
intensity-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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Eligible subjects must meet all of the following:
* Age ≥18 years.
* Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).
* Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \[T3-4 N0-3 M0, or T1-2 N2-3 M0\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).
* Suitable for definitive radiotherapy with curative intent.
* At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:
* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;
* ECOG Performance Status \>2 (if this criterion is met, the ECOG criterion listed below may be waived);
* Renal dysfunction: creatinine clearance (CrCl) \<50 mL/min (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);
* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);
* Peripheral neuropathy \> Grade 1;
* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.
* Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible (no need to retest if previously tested).
* ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).
* At least one measurable lesion per RECIST 1.1.
* Expected survival ≥6 months.
* Adequate hematologic function: WBC ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L.
* Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault):
* Female CrCl = (140 - age) × weight (kg) × 0.85 / (72 × S\_cr \[mg/dL\])
* Male CrCl = (140 - age) × weight (kg) × 1.00 / (72 × S\_cr \[mg/dL\])
* Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
* Voluntary participation: signed written informed consent and ability to comply with visits and procedures.
Exclusion Criteria:
* Any of the following excludes enrollment:
* Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.
* Participation 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 (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).
* Known HIV infection, or active viral hepatitis or active tuberculosis.
* Major surgery within 90 days before first study treatment, or planned surgery during the study.
* Known allergy to nimotuzumab or its excipients.
* Deemed unsuitable to participate by the investigator.
* Unwilling or unable to sign informed consent.
* Receipt of a live vaccine within 30 days before first dose.
Primary outcome measure(s)
Progression-Free Survival (PFS) — 24 months after treatment initiation the proportion of patients in a clinical study who remain free of disease progression (including local recurrence, regional lymph node metastasis, distant metastasis, or second primary malignancy) and have not died from any cause within 2 years from the start of treatment (or randomization in randomized controlled trials).
Trial sites (1)
Facility
City
Region
Status
Shandong First Medical University Affiliated Cancer Hospital
Shandong
Province
Recruiting
More Shandong Cancer Hospital and Institute trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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