Nasopharyngeal Carcinoma
Conditions
Interventions
experimental group:The patient will receive GP induction chemotherapy (Gemcitabine 1g/m2 on days 1 and 8 + Cisplatin 80mg/m^2, given from days 1 to 3, every 3 weeks) for 3 cycles
Intensity-modulated radiotherapy (dose 70Gy in 33 fractions, individual fraction dose 2.12Gy, given once daily, 5 days a week)
starting from the first cycle of induction chemotherapy, we will also administer Camrelizumab (200mg intravenous infusion every 3 weeks) for 3 cycles during the induction chemotherapy and radiotherapy
Control Group:Patients will receive GP induction chemotherapy (Gemcitabine 1g/m2 on days 1 and 8 + Cisplatin 80mg/m2 administered in total over days 1-3, every 3 weeks) for 3 cycles
Intensity-modulated radiotherapy (dose of 70Gy in 33 fractions, with a per-fraction dose of 2.12Gy, administered once daily, 5 days a week).
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and 1.5×10?/L, hemoglobin >=90 g/L,and platelet count >=100×10?/L. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 ml/min (calculated using the Cockcroft-Gault formula). 8. Patients must provide written informed consent and must be willing and able to comply with all study-related visits, treatment plans, laboratory tests, and other requirements. 9. Women of childbearing potential must agree to use a reliable method of contraception from the screening visit until 1 year after the last dose of PD-1 inhibitor (camrelizumab). Men with partners of childbearing potential must also agree to use a reliable method of contraception from the screening visit until 1 year after the last dose of PD-1 inhibitor (camrelizumab).
Exclusion criteria
Exclusion criteria: 1. Hepatitis B surface antigen (HBsAg) positive with HBV DNA > 200 IU/ml or 1000 copies/ml. 2. Positive for hepatitis C virus (HCV) antibody. 3. Active, known, or suspected autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome, ulcerative colitis, Crohn’s disease, myasthenia gravis, Hashimoto’s thyroiditis, and Graves’ disease. Participants with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) are eligible. 4. History of interstitial lung disease. 5. Systemic corticosteroids or other immunosuppressive therapy within 28 days before signing the informed consent, equivalent to > 10 mg prednisone per day. Participants receiving systemic corticosteroids 1 year ago are also excluded unless they have completed standard anti-tuberculosis therapy. 7. Receipt or planned receipt of live vaccines within 30 days before signing the informed consent. 8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential who are sexually active). 9. Other malignancies within the past 5 years, except for carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer. 10. Known hypersensitivity to macromolecular protein preparations or any components of PD-1 inhibitors (camrelizumab). 11. Human immunodeficiency virus (HIV) infection. 12. Other conditions that may affect participant safety or study compliance, as judged by the investigator, including symptomatic heart failure, stable angina, myocardial infarction, active infections requiring systemic treatment, psychiatric disorders, or social and family factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event-free survival(EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS);distant metastasis-free survival(DMFS);locoregional recurrence-free survival(LRRFS);adverse event(AE);serious adverse event(ASE) ;quality of life(QOL);Efficacy of PD-1 Inhibitor (Camrelizumab) in Different Subgroups; | — |
Countries
China
Contacts
Public ContactChen Nianyong
West China Hospital of Sichuan University
Outcome results
None listed