Squamous cell carcinoma of head and neck
Conditions
Interventions
the Experimental Group (radiotherapy + nimotuzumab) :Intensity-modulated technique (photon IMRT or proton IMPT)
total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.Nimotuzumab 200 mg IV once weekly for 7 weeks.
the Control Group (radiotherapy alone):Intensity-modulated technique (photon IMRT or proton IMPT)
total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Histologically confirmed stage III–IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx). 3. 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). 4. Suitable for definitive radiotherapy with curative intent. 5. At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy: (1) Age >=65 years and, in the investigator’s judgment, unable to tolerate chemotherapy; (2) ECOG Performance Status >2 (if this criterion is met, the ECOG criterion listed below may be waived); (3) Renal dysfunction: creatinine clearance (CrCl) =25 dB loss at two consecutive frequencies); (5) Peripheral neuropathy > Grade 1; (6) Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator’s judgment. 6. 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). 7. ECOG Performance Status 0–1 (or Karnofsky Performance Status =80). 8. At least one measurable lesion per RECIST 1.1. 9. Expected survival >=6 months. 10. 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. 11. Adequate renal function: serum creatinine =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]) 12. Adequate liver function: total bilirubin <=1.5×ULN; AST <=2.5×ULN; ALT <=2.5×ULN. 13. Voluntary participation: signed written informed consent and ability to comply with visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment. 2. Participation in another interventional clinical trial within 30 days prior to screening. 3. History of other malignancy (except cured basal cell carcinoma of the skin). 4. History of primary immunodeficiency. 5. Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness). 6. Known HIV infection, or active viral hepatitis or active tuberculosis. 7. Major surgery within 90 days before first study treatment, or planned surgery during the study. 8. Known allergy to nimotuzumab or its excipients. 9. Deemed unsuitable to participate by the investigator. 10. Unwilling or unable to sign informed consent. 11. Receipt of a live vaccine within 30 days before first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year locoregional control (LRC) rate;2-year distant metastasis rate;2-year overall survival (OS) rate;Objective response rate (ORR);Quality of life (QoL);Safety; | — |
Countries
China
Contacts
Public ContactYu Jinming/Hu Man
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed