Nasopharyngeal Carcinoma
Conditions
Interventions
single-arm:(1) Induction chemotherapy plus immunotherapy: Benmelstobart plus docetaxel, cisplatin, and 5-fluorouracil (docetaxel 60 mg/m2 on Day 1
cisplatin 60 mg/m2 on Day 1
fluorouracil 600 mg/m2 on Days 1–5
benmelstobart 1200 mg per dose on Day 1). Induction chemoimmunotherapy will be administered every 3 weeks per cycle for a total of 3 cycles.
(2) Concurrent chemoradiotherapy:
(a) Radiotherapy regim
GTVnd, 64–70 Gy
CTV1, 60–62 Gy
CTV2, 54–56 Gy, delivered in 30–33 fractions. Radiotherapy will be administered once daily, 5 days per week.
(b) Concurrent chemotherapy: Cisplatin 100 mg/m2 every 3 weeks per cycle throughout the c
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years. 2. Histologically confirmed non-keratinizing nasopharyngeal carcinoma. 3. Stage III–IVA disease according to the UICC/AJCC 8th edition (excluding T3–4N0–1). 4. No distant metastasis; no prior anti-tumor therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 6. Adequate hematologic, hepatic, renal, and coagulation function meeting all of the following: (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelet count >= 100 × 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Serum albumin >= 30 g/L; (5) Total bilirubin 60 mL/min; (8) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN (patients receiving stable-dose anticoagulation such as low-molecular-weight heparin or warfarin may be eligible if the INR is within the expected therapeutic range for anticoagulation).
Exclusion criteria
Exclusion criteria: 1. Receiving treatment intended for palliation. 2. Concomitant malignancy. 3. History of malignancy. 4. Prior treatment with any therapy targeting tumor immune mechanisms, including immune checkpoint inhibitors (e.g., anti–PD-1, anti–PD-L1, anti–CTLA-4 antibodies) or agents targeting immune costimulatory molecules (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40). 5. Requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) or other systemic immunosuppressive medications within 2 weeks prior to randomization; the following are permitted: (1) Inhaled, ophthalmic, or topical corticosteroids at doses = II; (2) Severe arrhythmia requiring long-term pharmacologic intervention (asymptomatic atrial fibrillation with a stable ventricular rate is permitted); (3) Cerebrovascular accident (CVA) within 6 months prior to randomization; (4) Left ventricular ejection fraction (LVEF) 1000 IU/mL; or active hepatitis C. Note: inactive/asymptomatic HBV carriers with controlled disease after treatment and stable HBV DNA<= 1000 IU/mL are eligible. Participants with cured hepatitis C (anti-HCV positive and HCV RNA negative) are eligible. 14. Active inflammatory bowel disease (e.g., Crohn disease, ulcerative colitis) or active diverticulitis, or a documented history thereof. 15. Known history of solid organ allogeneic transplantation or allogeneic hematopoietic stem cell transplantation. 16. Known history of severe hypersensitivity reactions to other monoclonal antibodies. 17. Pregnant or breastfeeding women. 18. Any condition that, in the investigator’s judgment, may increase the risk of study treatment, interfere with the evaluation of the study drug, compromise participant safety, or confound interpretation of the study results (e.g., other serious medical illnesses or psychiatric disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;3-year Failure-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Overall Survival; | — |
Countries
China
Contacts
Public ContactQiu Xingsheng
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed