nasopharyngeal carcinoma
Conditions
Interventions
Study Group:1.Induction Chemotherapy (GP Regimen combined with Toripalimab) -GP Regimen: Gemcitabine: 1000 mg/m2 on Day 1 and Day 8
Cisplatin (DDP): 80 mg/m2 on Day 1-3
every 3 weeks for 3 cycles -Toripalimab: For patients weighing = 40 kg: 240 mg on Day 1
For patients weighing < 40 kg: 3 mg/kg
every 3 weeks for 3 cycles 2. Concurrent Chemoradiotherapy (CCRT): Cisplatin (DDP): 100 mg/m2, starting on the first day of radiotherapy
every 3 weeks for 3 cycles.
Control Group:1. Induction Chemotherapy (GP Regimen): Gemcitabine: 1000 mg/m2 on Day 1 and Day 8
Cisplatin (DDP): 80 mg/m2 on Day 1-3, every 3 weeks for 3 cycles. 2. Concurrent Chemoradiotherapy (CCRT): Cisplatin (DDP): 100 mg/m2, starting on the first day of radiotherapy, every 3 weeks for 3 cyc
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients must be informed of the investigational nature of this study and give written informed consent. 2. Age between 6 and 18 years, regardless of gender. 3. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO Type II or III). 4. Clinical stage II-III (according to AJCC 9th edition), excluding T3N0 and T3N1 (only with retropharyngeal lymph node metastasis); patients must be newly diagnosed with nasopharyngeal carcinoma. 5. ECOG performance status of 0-1. 6. Females of childbearing potential must agree to use contraception during the study period. 7. Hemoglobin (HGB) >= 90 g/L, white blood cell count (WBC) >= 4×10^9/L, platelet count (PLT) >= 100×10^9/L. 8. Normal liver function test: ALT and AST < 2.5 x upper limit of normal (ULN), total bilirubin < 2.0×ULN. 9. Adequate renal function: Serum creatinine < 1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Age > 18 years. 2. Presence of recurrence or distant metastasis. 3. Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO Type I). 4. History of previous anti-tumor treatment. 5. Pregnant or lactating women, and women of childbearing potential not using effective contraception. 6. HIV positive. 7. History of malignancy within the past 5 years, except for patients with carcinoma in situ, adequately treated non-melanoma skin cancer, or papillary thyroid carcinoma. 8. Patients with other immunodeficiency diseases or a history of organ transplantation. 9. Patients with active autoimmune diseases, except for type I diabetes, hypothyroidism under replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 10. Conditions requiring systemic corticosteroids (equivalent to prednisone >10 mg/day) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients on systemic corticosteroids equivalent to prednisone =10 mg/day or using inhaled or topical corticosteroids are permitted. 11. Received a live vaccine within 30 days before signing informed consent or planning to receive a live vaccine in the near future. 12. Patients with significant impairment in heart, liver, lung, kidney, or bone marrow function. 13. Severe, uncontrolled medical diseases or infections. 14. Concurrent use of other investigational drugs or participation in other clinical trials. 15. Refusal or inability to sign the informed consent form to participate in the trial. 16. Known allergies to large molecule protein products or any PD-1 antibody compounds, or those with other contraindications to the treatment. 17. Individuals with personality or mental disorders, those without legal capacity or with limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completely response (CR) rate after induction chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Progression-free survival(PFS);Locoregional failure-free survival(LRRFS);Distant metastasis-free survival(DMFS);Incidence of acute and late toxicity;Hormone levels;Growth condition;Quality of life; | — |
Countries
China
Contacts
Public ContactLuo Donghua
Sun Yat-sen University Cancer Center
Outcome results
None listed