Localized advanced nasopharyngeal carcinoma
Conditions
Interventions
research group:EGFR
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: Both males and females aged 18-75 are eligible; 2. Nasopharyngeal carcinoma patients diagnosed by pathology (including histology or cytology), with clinical staging of stage III-IV (excluding T3N0-1) (according to the UICC/AJCC TNM staging system (8th edition)); 3. Has not undergone systematic treatment in the past (surgery, radiotherapy, chemotherapy, etc.); 4. At least one imaging examination can measure the lesion (RECIST standard version 1.1); 5. ECOG score: 0-1 points; 6. Expected survival period >= 3 months; 7. The main organ functions normally and meets the following criteria:1. Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB>= 90g/L, b. WBC>= 4×10^9/L c. ANC>= 1.5×10^9/L, d. PLT>= 100×10^9/L; 2.Biochemical tests must meet the following standards: a. BIL= R2 grade hearing loss (CTCAE5.0), c. >= R2 grade peripheral neuropathy (CTCAE5.0), d. New York Heart Associ; 9. Male participants and women of childbearing age must use contraception within 24 weeks from the start of the first dose of the study drug to the end of the study drug; 10. Researchers believe that treatment has survival benefits.
Exclusion criteria
Exclusion criteria: 1. Active, known or suspected autoimmune diseases; 2. Patients with hypertension who cannot be reduced to the normal range through antihypertensive medication (systolic blood pressure>160 mmHg, diastolic blood pressure>90 mmHg); 3. There is a genetic tendency for bleeding or coagulation dysfunction. Screening for clinically significant bleeding symptoms or clear bleeding tendency within 12 weeks (cumulative bleeding volume exceeding 50ml within 24 hours); 4. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) unstable angina pectoris (2) myocardial infarction within 24 weeks (3) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 5. Interstitial lung Diseases, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, active pneumonia with clinical symptoms, or severe pulmonary dysfunction; 6. The subject has active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) and hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the detection limit of the analytical method); 7. Individuals who have allergic reactions to the medication used in this application; 8. Pregnant or lactating women; 9. According to the researchers' assessment, there are other factors that may have led to the forced termination of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute adverse reactions (AE) of grade >= 3 after induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year Overall Survival, OS ;2-year Progression Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactYu Yifeng; Wu Sangang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed