nasopharyngeal, hypopharyngeal and laryngeal cancers
Conditions
Interventions
experimental group:Nituzumab combined with concurrent chemoradiotherapy
Sponsors
People's Hospital Affiliated to Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS score 0-2; 3. Stage III-IVb confirmed by histopathology or cytology (according to the 2020 CSCO Head and Neck Tumor Diagnosis and Treatment Guidelines) nasopharyngeal carcinoma, hypopharyngeal carcinoma, and laryngeal carcinoma; 4. Histopathological and immunohistochemical test showed positive expression of EGFR 5. Patients who are not suitable for surgery (defined as patients whose physical condition does not allow or refuse surgery for various reasons); 6. According to the RECIST 1.1 evaluation criteria, there is at least one measurable lesion; 7. It is suitable for receiving radiotherapy and chemotherapy for the purpose of radical cure. 8. Expected survival time >= 3 months; 9. Hematological indicators are basically normal: white blood cell count >=4x10^9/L; absolute neutrophil count >=1.5x10^9/L; platelet >=100x10^9/L; hemoglobin >=90 g/L 10. Renal function is basically normal: serum creatinine =60mL/min 11. Liver function is basically normal: serum total bilirubin <=1.5xULN (if there is liver metastasis, serum total bilirubin should be <=3.0xULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5x ULN (<=5.0xULN, if there is liver metastasis). 12. Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) 13. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI treatment, anti-angiogenesis drugs, immunosuppressive agents within six months; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Patients with distant metastases; 4. A history of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors cured for more than 5 years); 5. Poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 6. Known to be infected with HIV virus or active viral hepatitis; 7. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose> 10 mg/day or equivalent dose); 8. Those who are allergic to the drugs or their components used in this program; 9. According to the standard of common adverse event term (NCI CTCAE V5.0), >= 2 grade peripheral neurological disease or hearing loss; 10. Pregnancy (confirmed by menstrual blood or urine HCG test) or breastfeeding women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least after the last trial treatment 6 months; 11. The researcher thinks that it is not suitable to participate in this research; 12. Those who are unwilling to participate in this study or unable to sign the informed consent form.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 2 year progression-free survival (PFS) rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR) ;Total tumor response rate (CRR) ;Disease Control Rate;2 year total survival (OS) rate ;Local control rate for 2 years ;Medina progression-free survival (PFS) ;living quality; | — |
Countries
china
Contacts
Public ContactLi Xinhong
Department of Radiotherapy, People's Hospital Affiliated to Inner Mongolia Medical University
Outcome results
None listed