nasopharyngeal carcinoma
Conditions
Interventions
research group:Immunotherapy with Carolizumab during Induction Chemotherapy for Nasopharyngeal Cancer
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old 2. Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) have a clinical staging of T1-4N2-3M0 (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 PS:0-1 6.6. Expected survival time = 3 months; 7. The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB = 100g/L, b. WBC = 3 × 109/L c. ANC = 1.5 × 109/L, d. PLT = 100 × 109/L; (2) Biochemical examination must meet the following standards: a. BIL60ml/min (Cockcroft Gault formula) 8. Male participants and women of childbearing age must take the first study medication until the last study medication is administered 9. The main organ function is normal, and the blood routine, blood biochemistry, and coagulation function tests are basically normal; 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 after treatment with antihypertensive drugs (systolic blood pressure>160 mmHg, diastolic blood pressure>90 mmHg); 3. There is a hereditary tendency for bleeding or coagulation dysfunction. Screening for clinically significant bleeding symptoms or clear bleeding tendencies within 12 weeks (cumulative bleeding volume exceeding 50ml within 24 hours); 4. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 24 weeks, (4) clinically significant supraventricular or ventricular arrhythmias that 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 104 copies/mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the detection limit of the analysis method); 7. Individuals who have allergic reactions to the drugs used in this application; 8. Pregnant or lactating women; 9. According to the researcher's judgment, there are other factors that may cause the study to be forced to terminate midway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate after induction therapy;Complete response rate after induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year recurrence free survival;2-year survival rate without distant metastasis;2-year disease free survival;2-year overall survival ;safety; | — |
Countries
China
Contacts
Public Contactsangangwu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed