head neck cancer
Conditions
Interventions
Group 1 :Docetaxel and cisplatin induction chemotherapy combined with nimotuzumab and penpulimab followed by concurrent chemoradiotherapy
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Stage III-IVB (according to the 2020 CSCO guidelines for the diagnosis and treatment of head and neck tumors) confirmed by histopathology or cytology) head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasal cavity and Sinus tumors, except nasopharyngeal carcinoma); 3. Patients who are not suitable for surgery (defined as: the tumor cannot reach R0 resection; the patient is inoperable due to physical conditions, personal wishes or medical reasons); 4. Suitable for radiotherapy for the purpose of radical cure; 5. For patients with oropharyngeal cancer, HPV status should be confirmed by HPV-DNAISH before enrollment; 6. ECOG PS score 0-1; 7. Immunohistochemical detection of EGFR (1+ or above); 8. According to the evaluation criteria of RECIST version 1.1, there is at least one measurable lesion; 9. Hematological indicators are basically normal: white blood cell count >= 4 x 10^9/L; absolute neutrophil count >= 1.5 x 10^9/L; platelet >= 100 x 10^9/L; hemoglobin >= 90 g/L; 10. Renal function is basically normal: serum creatinine 60 mL/min (using the Cockcroft-Gault formula): 11. Female CrCl = (140-age) x body weight (kg) x 0.85/(72×Scrmg/dl); 12. Male CrCl = (140-age) x weight (kg) x 1.00/(72×Scrmg/dl); 13. The liver function is basically normal: serum total bilirubin <= 1.5 x ULN; aspartate aminotransferase (AST) <= 2.5 x ULN; alanine aminotransferase (ALT) <= 2.5 x ULN; 14. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received immunotherapy and targeted therapy; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Those with a history of other malignant tumors (except cured basal cell carcinoma of the skin); 4. History of primary immunodeficiency; 5. There are concurrent diseases that are poorly controlled (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.); 6. Known HIV infection or active viral hepatitis or tuberculosis; 7. Major surgery or planned surgery within 90 days before taking the test drug for the first time; 8. Those who are allergic to the drugs used in this program or their ingredients; 9. Pregnant (confirmed by blood or urine HCG test) or lactating 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; 10. The researcher thinks it is not suitable to participate in this research; 11. Those who are unwilling to participate in this study or unable to sign the informed consent; 12. Inoculate live vaccines within 30 days of administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival;2-year Distant Metastasis-Free Survival;adverse event;quality of life; | — |
Countries
China
Contacts
Public ContactShi Mei
Xijing Hospital
Outcome results
None listed