Patients with locally advanced nasopharyngeal carcinoma (stage III-IVA, UICC/AJCC 8th edition) who have not received systematic treatment before.
Conditions
Interventions
Test group:Induction therapy: paclitaxel 135mg/m ^ 2 or albumin bound paclitaxel 260 mg/m ^ 2 or docetaxel 75 mg/m ^ 2 (d1)+cisplatin 75mg/m (divided into 2 d1-3)+ticagrelor based on body surface area
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >= 18 years old; 2. Nasopharyngeal carcinoma patients diagnosed by pathology (including histology or cytology), with clinical stage III-IV (excluding T3N0-1) (according to the UICC/AJCC TNM staging system (8th edition)); 3. No previous systemic treatment (surgery, radiotherapy, chemotherapy, etc.); 4. At least one imaging examination can measure the lesion (RECIST standard version 1.1); 5. ECOG PS:0-1; 6. Expected survival period >= 3 months; 7. The main organ functions are normal and meet the following criteria: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB >= 100g/L, b. WBC >= 3 × 10^9/L, c. ANC >= 1.5 × 10^9/L, d. PLT >= 100 × 10^9/L; (2) Biochemical examination must meet the following criteria: a. BIL60ml/min (Cockcroft Gault formula); 8. 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; 9. The main organ functions are normal, and the blood routine, blood biochemistry, and coagulation function tests are basically normal; 10. Researchers believe that treatment has survival benefits; 11. The patient voluntarily participates in this study and provides written informed consent;
Exclusion criteria
Exclusion criteria: 1. Active, known or suspected autoimmune diseases; 2. Patients with hypertension who cannot be reduced to 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) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Has experienced myocardial infarction within 24 weeks; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; 5. Interstitial lung disease, 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 10^4 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. Other researchers consider it inappropriate to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate in imaging studies; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year survival rate without distant metastasis;2-year survival rate;disease control rate;2-year local recurrence free survival rate; | — |
Countries
China
Contacts
Public ContactWu Sangang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed