head and neck squamous cell carcinoma
Conditions
Interventions
treatment arm:Nimotuzumab
control group:Intensity Modulated Radiation Therapy
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Histologically confirmed squamous cell carcinoma of the head and neck (oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer), oropharyngeal cancer must be p16 negative (p16 >= 70% is positive); 3. Radical surgery has been completed, and there are any high-risk factors after surgery: ? lymph node extracapsular invasion (ENE); ? pT3-4; pN2-3; ? nerve invasion (PNI); vascular invasion (LVI); ? level IV or Level V lymph node metastasis (oral/oropharyngeal cancer); ? Close to the resection margin ( 65 years; ? ECOG PS score: > 2 points; ? renal dysfunction (creatinine clearance rate Grade 1 peripheral neuropathy; ? Unacceptable venous hydration, such as due to cardiac dysfunction or other comorbidities (Investigator judgment); ? patient refused cisplatin chemotherapy; 5. Imaging examinations do not suggest distant metastasis of the disease; 6. Expected survival period >= 6 months; 7. The function of major organs is normal, that is, the following criteria are met: The standard of blood routine examination must meet: (No blood transfusion or blood products within 14 days before screening) –Hb >=90g/L; –ANC >=1.0×10^9/L; –PLT >=80×10^9/L – White blood cell count >=4×10^9/L; Biochemical tests must meet the following criteria: (no blood transfusion or blood products within 14 days prior to screening) – Serum total bilirubin (TBIL) <=1.5×ULN; – Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative, and they are willing to use reliable methods of contraception during the trial; male subjects need to start to the last medication before treatment Use reliable contraception for the next 120 days; 9. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, anti-angiogenic drugs within 4 weeks before enrollment; 2. Participated in other interventional clinical trials within 30 days before screening; 3. History of other malignant tumors in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ; 4. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 5. Known HIV infection or active viral hepatitis or tuberculosis; 6. Major surgery or planned surgery within 30 days before taking the trial drug for the first time; 7. Those who are allergic to the drugs or their components used in this program; 8. Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both male and female subjects) until at least after the last trial treatment 6 months; 9. The researcher believes that it is not suitable to participate in the researcher; 10. Those who are unwilling to participate in this study or unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Local area recurrence free survival;Distant metastasis free survival;Quality of life assessed by EORTC QLQ-H&N35; | — |
Countries
China
Contacts
Public ContactTao Lei
Eye and ENT Hospital of Fudan University
Outcome results
None listed