nasopharynx cancer
Conditions
Interventions
Test group :Induction Phase:GP regimen (Gemcitabine + Cisplatin) + Sintilimab, 3 cycles
Radiotherapy Phase:Concurrent chemoradiotherapy
Sponsors
Taizhou hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed primary nasopharyngeal carcinoma (NPC). 2. Staged as T4N1M0 or T1-4N2-3M0 (according to AJCC Staging System, 9th Edition). Note: Patients should undergo contrast-enhanced magnetic resonance imaging (MRI) of the nasopharynx and PET-CT for staging before treatment; if contraindicated, contrast-enhanced computed tomography (CT) is acceptable. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 4. Neutrophil count >= 1.5 × 10?/L, hemoglobin = 90 g/L, platelet count >= 100 × 10?/L. 5. Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) = 60 mL/min (calculated using the Cockcroft-Gault formula). 7. The patient must sign an informed consent form and be willing and able to comply with the visits, treatment plan, laboratory tests, and other requirements specified in the study protocol. 8. Female subjects of childbearing potential (WOCBP) must agree to use reliable methods of contraception from the screening visit until 1 year after the last dose of sintilimab; male subjects with female partners of childbearing potential must agree to use reliable methods of contraception from the screening visit until 1 year after the last dose of sintilimab.
Exclusion criteria
Exclusion criteria: 1. Age > 75 years or 10 mg prednisone per day or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Subjects receiving systemic corticosteroids =10 mg prednisone per day or inhaled/topical corticosteroids may be enrolled. 7. Administration of a live vaccine within 30 days prior to signing the informed consent or planned administration during the study. 8. Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential, if applicable). 9. Malignancy other than carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. 10. Known prior hypersensitivity to large protein preparations or any component of sintilimab. 11. Human immunodeficiency virus (HIV) infection. 12. Any other condition that, in the judgment of the investigator, may affect subject safety or trial compliance, including: symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, psychiatric illness, or familial/social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major PMR ratio; | — |
Countries
China
Contacts
Public ContactHaihua Yang
Taizhou hospital of Zhejiang Province
Outcome results
None listed