Head and neck tumor
Conditions
Interventions
Experimental group:Postoperative adjuvant radiotherapy + targeted therapy
Control Group:Postoperative adjuvant radiotherapy
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 18-75 years; 2. Histologically confirmed locally advanced (AJCC 8th edition III-IVB) head and neck squamous cell carcinoma (oral cancer, HPV-negative oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer); 3. Completed radical surgery and has one or more 'intermediate risk' factors postoperatively: (1) Primary tumor pathological stage T3-T4; (2) Lymph node pathological stage N2a-N3a; (3) T2 oral cancer with invasion depth >5mm; (4) Perineural invasion; (5) Lymphovascular tumor thrombus; (6) Pathology indicates poorly differentiated squamous cell carcinoma; 4. Imaging does not indicate distant metastasis; 5. The patient must provide sufficient tissue samples for EGFR testing; for oropharyngeal cancer, samples must be provided for HPV/p16 testing (if previously tested, no need to retest); 6. Expected survival time >=6 months; 7. ECOG PS score 0-1; 8. Major organ functions are normal, meeting the following criteria: Hematology test criteria must meet: (no blood transfusion or blood products within 14 days before screening) (1) Hb >=90 g/L; (2) ANC >=1.0×10^9 /L; (3) PLT >=80×10^9 /L; (4) White blood cell count >=3×10^9/L; Biochemical test criteria must meet: (no blood transfusion or blood products within 14 days before screening) (1) Total serum bilirubin (TBIL) <=1.5×ULN; (2) AST and ALT <=2.5×ULN; 9. Women of childbearing potential must perform a pregnancy test (serum or urine) within 14 days before enrollment with a negative result and agree to use reliable contraception during the study; 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, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received radiotherapy and drug treatment for head and neck tumors prior to enrollment; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Postoperative pathology indicates the presence of one or more "high-risk factors": (1) Extracapsular extension (ENE) of lymph nodes; (2) Positive surgical margins; 4. Evidence of distant metastasis exists; 5. History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ; 6. Presence of poorly controlled comorbidities (such as heart failure, diabetes, hypertension, thyroid disease, psychiatric disorders, etc.); 7. Known infection with HIV or active viral hepatitis or tuberculosis; 8. Underwent major surgery or planned surgery within 30 days before the first dose of the investigational drug; 9. Allergic to any drugs or components used in this protocol; 10. Pregnant (confirmed by blood or urine HCG test) or breastfeeding women, or participants of reproductive 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; 11. Considered unsuitable for participation in this study by the investigator; 12. Unwilling to participate in this study or unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Disease-Free Survival (DFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Distant Metastasis-Free Survival (DMFS) rate;3-year Locoregional Recurrence-Free Survival (LRRFS) rate;Safety;Quality;3-year Overall Survival (os) rate;3-year Locoregional Failure(LRF)rate; | — |
Countries
China
Contacts
Public ContactLiu Rui
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed