Locally advanced nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Three cycles of albumin-bound paclitaxel + cisplatin induction chemotherapy
followed by concurrent chemotherapy and radiotherapy.
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, no gender limit. 2. Patients with nasopharyngeal carcinoma diagnosed by histology or cytology. 3. Patients with stage III-IVa defined by the American Joint Committee on Cancer Research (AJCC) staging system (8th edition), except T3-4N0. 4. There is at least one lesion that is judged to be measurable according to RECIST version 1.1. 5. Sign written informed consent before conducting any trial-related activities. 6. ECOG physical status is 0 or 1 point. 7. Neutrophils >= 1.5 G/L, platelet count >= 100 G/L and hemoglobin >= 90 g/L. 8. Total bilirubin = 60 mL/min (If the calculated creatinine clearance rate is less than 60 mL/min, the investigator can request a 24-hour creatinine clearance rate check for confirmation). 11. If they are fertile (applicable to both male and female subjects), take effective contraceptive measures until at least 3 months after the last dose of the trial treatment. 12. Good compliance and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received systemic chemotherapy. 2. Received major surgery or radiation therapy within 4 weeks before entering the trial. 3. Previously received treatment with monoclonal antibodies or signal transduction inhibitors targeting EGFR. 4. No legal capacity/restricted capacity. 5. It is known that allergic reactions will occur to any ingredient treated in this test. 6. Active infection, including active tuberculosis, known and confirmed human immunodeficiency virus (HIV) infection, or active hepatitis B/C virus infection (HBV/HCV) that causes liver damage or cirrhosis. 7. History of organ transplantation, autologous/allogeneic stem cell transplantation and kidney replacement therapy. 8. Asymptomatic severe hypertension or hypertensive crisis, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg. 9. Heart function damage, manifested as any of the following conditions: (1) Left ventricular ejection fraction = Grade 2 peripheral nerve diseases or hearing loss. 13. Subjects who have not recovered from any acute effects of previous surgery, chemotherapy or radiotherapy, that is, have not fallen to <= Grade 1 (CTCAE, version 4.03). If the nutritional status is stable, allow for chronic late-stage toxicity (pharyngeal/laryngotoxicity, dry mouth, abnormal speech, swallowing, etc.) from previous radiotherapy and/or surgery. 14. Known alcohol and/or drug abuse. 15. Medical or psychological conditions that prevent the subject from completing the experiment or signing the informed consent form. 16. Have a history or current history of tumors other than nasopharyngeal carcinoma, excluding non-melanoma skin cancer that has undergone radical treatment, cervical cancer in situ, or other cancers that have undergone radical treatment and have no signs of disease for at least 5 years. 17. Have received any study medication within 30 days before entering the trial. 18. Pregnant women (not confirmed by the serum ß-human chorionic gonadotropin [HCG] test) or lactating female subjects. 19. At the same time receive one other anti-tumor drug treatment. 20. Subjects who have any coexisting medical conditions or diseases judged by the investigator may harm the development of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactGui Lin
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed