Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Radiotherapy: Radiation is delivered using intensity-modulated radiotherapy (IMRT), with a total dose of 60 Gy (2 Gy/fraction, 30 fractions).
Concurrent targeted therapy: Cetuximab
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx); 3. Completed radical surgery and has any of the following intermediate-risk factors postoperatively: (1) pT3-4; pN2a; (2) Perineural invasion (PNI); lymphovascular invasion (LVI); (3) Poorly differentiated squamous cell carcinoma; (4) Metastasis to level IV or V lymph nodes (oral/oropharyngeal cancer); (5) Close surgical margin (5mm; 4. Tissue available for EGFR testing; for oropharyngeal cancer, tissue available for HPV/P16 testing; 5. ECOG performance status 0-1; 6. Imaging shows no evidence of distant metastases; 7. Expected survival >=6 months; 8. Major organ functions are normal, meeting the following criteria: Blood routine examination must meet the following standards (no transfusion or blood products within 14 days prior to screening): (1) Hb >= 90 g/L; (2) ANC >= 1.0 × 10^9 /L; (3) PLT >= 80 × 10^9 /L; (4) White blood cell count >= 4 × 10^9 /L; Biochemical tests must meet the following standards (no transfusion or blood products within 14 days prior to screening): (1) Serum 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 prior to enrollment and agree to use reliable contraception during the trial; male participants must use reliable contraception from before treatment until 120 days after the last dose; 10. Participants voluntarily join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic drugs within 4 weeks prior to enrollment; 2. Participated in other interventional clinical trials within 30 days prior to screening; 3. History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ; 4. Presence of poorly controlled comorbidities (such as heart failure, diabetes, hypertension, thyroid disease, psychiatric disorders, etc.); 5. Known HIV infection or active viral hepatitis or tuberculosis; 6. Major surgery within 30 days prior to the first dose of the trial drug or planned surgery; 7. Allergy to any drugs or components used in this protocol; 8. Pregnant (confirmed by blood or urine HCG test) or breastfeeding women, or participants of childbearing potential who are unwilling or unable to use effective contraception (applies to both male and female participants) until at least 6 months after the last trial treatment; 9. Considered unsuitable for participation in this study by the investigator; 10. Unwilling to participate in this study or unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate;2-year local recurrence free survival rate;2-year distant metastasis free survival rate;quality of life;safety;The impact of tumor related biomarkers on prognosis; | — |
Countries
China
Contacts
Public ContactZhang Ximei
Tianjin Cancer Hospital
Outcome results
None listed