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),
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.
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.
Parallel
Nimotuzumab
DrugTreatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).
intensity-modulated technique（IMRT）
RadiationTreatment 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.
Progression-Free Survival (PFS)
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).
2-year locoregional control (LRC) rate.
the proportion of patients in a clinical study who remain free of disease progression within 2 years from the start of treatment (or randomization in randomized controlled trials).
2-year distant metastasis rate.
the prproportion of participants with distant metastatic progression within 24 months,
Overall Survival (OS)
the prproportion of participants surviving at 2 years after enrolling,regardless of disease status.
Objective Response Rate (ORR; CR+PR by RECIST 1.1).
the proportion of patients with measurable malignant tumors who achieve a complete response (CR) or partial response (PR)
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