Nasopharyngeal Carcinoma
Conditions
Interventions
Research Group:Sintilimab Combined with Nab-TPC Regimen as Induction Therapy
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed, previously untreated nasopharyngeal carcinoma. 2.Aged 18-70 years. 3.Staged as T4N1M0 or T1-4N2-3M0 according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) clinical staging system ; 4.ECOG performance status (PS) score of 0 or 1. 5.Neutrophil count >= 1.5×10^9/L, hemoglobin >= 90 g/L, and platelet count >= 100×10^9/L. 6. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 60 mL/min (calculated using the Cockcroft-Gault formula). 8. Patients must provide signed informed consent and demonstrate willingness and ability to comply with study-related visits, treatment plans, laboratory tests, and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. HBsAg positive with HBV DNA >1×10^3 copies/mL. 2. HCV antibody positive. 3. Active, known, or suspected autoimmune disease. Subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) may be enrolled. 4. History of interstitial lung disease. 5. Received systemic corticosteroids equivalent to >10 mg prednisone/day or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Subjects receiving systemic corticosteroids =10 mg prednisone/day or inhaled/topical corticosteroids may be enrolled. 6. Received or are scheduled to receive live vaccines within 30 days prior to signing the informed consent form. 7. Women who are pregnant or lactating (for women of childbearing potential with sexual activity, pregnancy testing should be considered). 8. History of other malignant tumors within 5 years, except for carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. 9. Known history of allergy to macromolecular protein preparations or any component of Sintilimab. 10. Human Immunodeficiency Virus (HIV) infection. 11.Other conditions deemed by the investigator to potentially compromise subject safety or trial compliance, including symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or familial/social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;Safety and tolerability;2-year PFS;OS;2-year DMFS;2-year LRFS; | — |
Countries
China
Contacts
Public ContactYuLiang Zhu
Zhongshan People's Hospital
Outcome results
None listed