nasopharyngeal carcinoma
Conditions
Interventions
Test group:Surgery combined with GP and targeted immunotherapy
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. Diagnosed with nasopharyngeal carcinoma by pathological histology or cytology; 3. EGFR positive; 4. Local regional recurrence of nasopharyngeal carcinoma; 5. ECOG score is 0 - 1; 6. According to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), there is at least one measurable lesion; 7. Have adequate organ or bone marrow function: Laboratory test values within 7 days before enrollment meet the following requirements (no blood components, cell growth factors, albumin or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days before obtaining the laboratory tests), as follows: (1) Blood routine: Absolute neutrophil count (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 75×10^9/L; hemoglobin content (HGB) >= 9.0 g/dL. (2) Liver function: Serum total bilirubin (TBIL) = 28 g/L; alkaline phosphatase (ALP) = 50 mL/min (Cockcroft-Gault formula); for patients with urine protein >= 2+ in urine routine test results, 24-hour urine collection should be performed and 24-hour urine protein quantification should be = 12 weeks. 9. Urine or blood pregnancy tests are negative for women of childbearing age (except for those aged 45 or above with menopause for more than one year, and those who have undergone complete removal of the uterus or ovaries). 10. For female patients of childbearing age or male patients whose sexual partners are of childbearing age, effective contraceptive measures must be taken throughout the treatment period and for 6 months after the last medication administration. 11. Sign a written informed consent form and be able to follow the visit and related procedures as stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. Within 5 years prior to the first administration, diagnosed with any other malignant tumor, excluding cured cases of skin basal cell carcinoma, skin squamous cell carcinoma, and/or cured cases of carcinoma in situ. 2. Symptomatic congestive heart failure (New York Heart Association grade II-IV), with echocardiography indicating left ventricular ejection fraction (LVEF) 500 ms (calculated using the Fridericia method). 4. Acute or chronic active hepatitis B or hepatitis C patients, with hepatitis B virus (HBV) DNA > 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA > 10^3 copies/ml; positive for both hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Can be enrolled if below the above standards after nucleotide antiviral treatment. 5. Received radiotherapy within 3 weeks prior to the first administration. For patients who received radiotherapy within 3 weeks prior to the first administration, must meet all of the following conditions to be enrolled: no current radiation-related toxic reactions, no need to take glucocorticoids, no exclusion of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc. 6. Previously received PD1, or PDL1, or CTLA4 immunotherapy. 7. Has an allergic history to the drugs used in this study and their components. 8. Pregnant or lactating women, fertile women/men who do not wish to take effective contraceptive measures during the treatment period and within 6 months after the treatment, and those who donate sperm within the specified time. 9. With distant metastasis. 10. Participated in other clinical trials within 4 weeks prior. 11. Uncontrolled hypertension, with systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg after optimal medical treatment, history of hypertension crisis or hypertension encephalopathy. 12. Had any life-threatening bleeding events within 3 months prior, including requiring blood transfusion treatment, surgery or local treatment, continuous drug treatment. 13. Had a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function, etc. 14. Active pulmonary tuberculosis (TB), those currently undergoing anti-TB treatment or those who received anti-TB treatment within 1 year prior to the first administration. 15. Human immunodeficiency virus (HIV) (HIV 1/2 antibody positive), those with known syphilis infection requiring treatment. 16. Active or poorly controlled severe infections. Those with severe infections within 4 weeks prior, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications. 17. Had an active autoimmune disease requiring systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first administration. Allowed to use alternative therapies (such as thyroid hormone, insulin, or physiological doses of systemic corticosteroids for adrenal or pituitary insufficiency). Known primary immunodeficiency history. Only patients with positive autoantibodies need to be confirmed by the investigator whether they have an autoimmune disease based on the study's judgment. 18. Used immunosuppressive drugs within 4 weeks prior to the first administration, excluding nasal, inhalation, or other local glucocorticoids or systemic glucocorticoids w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR ; | — |
Countries
China
Contacts
Public ContactQiu Qianhui
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Outcome results
None listed