Nasopharyngeal Carcinoma
Conditions
Interventions
treatment group:Carrelizumab combined with GP induction chemotherapy, cisplatin concurrent chemoradiotherapy and capecitabine adjuvant chemotherapy
Sponsors
Affiliated Cancer Hospital&Institute of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO pathological type II or III); 2. According to the AJCC/UICC staging Criteria, eighth edition (refer to the Appendix in Section 12.1), the primary tumor was staged as T4 and met any of the following requirements: (1) Primary tumor (GTVnx) volume > 30 cm3; (2) The primary lesion extensively invaded 2 or more of the following structures: pterygopalatine fossa, cavernous sinus, intracranial, cranial nerves, orbit, and parotid gland; (3) Multiple cervical lymph node metastases with any lymph node > 4 cm; (4) Regional lymph node staging was N3; 3. No distant metastasis (M0); 4. Aged 18-65 years; 5. White blood cell >= 4x10^9/L, platelet (PLT) >= 100x10^9/ L, hemoglobin >= 90 g/L; 6. Normal liver function (TBil, ALT, AST = 60 ml/min or creatinine <= 1.5xULN); 8. ECOG score 0-1;
Exclusion criteria
Exclusion criteria: 1. No radical chemoradiotherapy; 2. The primary tumor or lymph node has received chemotherapy or surgery (except for diagnostic procedures); 3. Previous history of malignancy, except for properly treated basal cell or squamous cell skin cancer or cervical cancer in situ; 4. Previous systemic antitumor therapy such as chemotherapy, targeted therapy and immunotherapy; 5. Previous radiotherapy history; 6. Pregnancy or lactation (for women of childbearing age, pregnancy tests should be conducted and effective contraception during treatment emphasized); 7. Co-existing diseases or complications that may pose unacceptable risks or effects, such as unstable heart disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory disease requiring hospitalization, active hepatitis, mental illness requiring treatment; 8. Known history of hypersensitivity to macromolecular protein products or any carizumab or cisplatin or any excipient; 9. History of autoimmune diseases, including but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with for antiphospholipid syndrome and wegener granulomatosis, Sjogren's syndrome, guillain-barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis (on a more comprehensive list of autoimmune diseases, see Appendix 12.9); patients with autoimmune related hypothyroidism who were receiving a stable dose of thyroid hormone replacement therapy were eligible to participate in the study; patients with controlled type 1 diabetes on a stable insulin regimen were eligible to participate in the study; 10. Receive systemic immune-stimulating drugs (including but not limited to interferon or IL-2) within 4 weeks before randomization or for 5 half-lives of the drug, whichever is shorter; 11. Received systemic corticosteroids (> 10 mg/day prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathathrine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs [anti-tnfi]) within 2 weeks prior to randomization; topical, ocular, intra-articular, intranasal, and inhaled corticosteroids were permitted. Patients receiving acute, low-dose systemic immunosuppressive agents (e.g., a single dose of dexamethasone for nausea) were enrolled in the study after discussion with the medical examiner and approval. To the baseline and follow-up MRI assessment of tumor patient has allergies to intravenous contrast agents, preventable using steroids. Allows the use of inhaled corticosteroids in patients with chronic obstructive pulmonary disease, cortical hormone (such as fludrocortisone) hydrochloric acid treatment of patients with orthostatic hypotension, low doses of corticosteroids maintenance treatment adrenocortical insufficiency; 12. Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation; 13. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (i.e., bronchiolitis obliterans), history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening; 14. Any other conditions, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness, or family/social factors, that the investigator believes may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years Failure-free Survival; | — |
Countries
China
Contacts
Public ContactJin-Quan Liu
The Affiliated Cancer Hospital&Institute of Guangzhou Medical University
Outcome results
None listed