Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Study Group:Radiotherapy:
Intensity-modulated radiation therapy (IMRT) shall be administered with a total dose of 60–66 Gy at 2 Gy per fraction, for 30–33 fractions.
Targeted Therapy:
Nimotuzumab 200
Control Group:Radiotherapy:
Intensity-modulated radiation therapy (IMRT) shall be administered with a total dose of 60–66 Gy at 2 Gy per fraction, for 30–33 fractions.
Sponsors
The First Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years; 2. Histologically confirmed locally advanced head and neck squamous cell carcinoma (HNSCC), including oral cavity cancer, HPV-negative oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer, staged as AJCC 8th edition Stage III–IVB; 3. Underwent radical surgical resection, with one or more postoperative intermediate-risk factors: (1) Pathological primary tumor stage T3–T4; (2) Pathological nodal stage N2a–N3a; (3) T2 oral cavity cancer with depth of invasion >5 mm; (4) Perineural invasion; (5) Lymphovascular invasion; (6) Poorly differentiated squamous cell carcinoma on histopathology; 4. No evidence of distant metastasis on imaging; 5. Sufficient tumor tissue available for EGFR testing; for oropharyngeal carcinoma, tissue must be available for HPV/p16 testing (testing is not required if results are already available); 6. Expected overall survival =6 months; 7. ECOG performance status score of 0 or 1; 8. Adequate organ function, defined as follows (no transfusion within 14 days prior to screening): Hematology: (1) Hemoglobin (Hb) =90 g/L; (2) Absolute neutrophil count (ANC) =1.0×10^9/L; (3) Platelet count (PLT) =80×10^9/L; (4) White blood cell count =3.0×10^9/L; Biochemistry: (1) Total bilirubin (TBIL) =1.5×ULN; (2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5×ULN; 9. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and agree to use highly effective contraception during the study; male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose; 10. Voluntarily provides written informed consent, demonstrates good compliance, and is willing to comply with study follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy or systemic pharmacotherapy for head and neck cancer before enrollment; 2. Participation in another interventional clinical trial within 30 days prior to screening; 3. Presence of one or more high-risk factors on postoperative pathology: (1) Extranodal extension (ENE); (2) Positive surgical margin; 4. Evidence of distant metastasis; 5. History of other malignancy within the past 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ; 6. Uncontrolled concurrent medical conditions, including but not limited to heart failure, diabetes mellitus, hypertension, thyroid disorders, and psychiatric diseases; 7. Known HIV infection, active viral hepatitis, or active tuberculosis; 8. Major surgical procedure within 30 days prior to the first administration of study treatment, or planned major surgery during the study period; 9. Hypersensitivity to the study drugs or any of their components; 10. Pregnant (confirmed by serum or urine HCG test) or lactating female subjects; or subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment; 11. Subjects considered by the investigator to be ineligible for study participation for any other medical or clinical reason; 12. Subjects unwilling to participate in the study or unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year disease free survival (DFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year overall survival (OS) rate;3?year locoregional recurrence?free survival (LRRFS) rate;3 year distant metastasis free survival (DMFS) rate;3 year locoregional failure (LRF) rate;Quality of life (QoL);Safety; | — |
Countries
China
Contacts
Public ContactLiu Rui
The First Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed