Patients with locally advanced nasopharyngeal carcinoma who did not respond (assessed as SD/PD by imaging) to immunotherapy combined with platinum-based chemotherapy
Conditions
Interventions
Experimental group:Gradient hyperfractionated intensity-modulated radiotherapy
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III); 2. Clinical stage: T1-2N2M0, T3N0-2M0 (Stage III) and T4N0-2M0, T1-4N3M0 (Stage IVa) (AJCC 8th Edition staging). 3. The therapeutic effect after induction treatment with 3 courses of platinum-based chemotherapy combined with immunotherapy was evaluated as SD/PD by nasopharyngoscopy and enhanced MRI of the nasopharynx and neck, or EBV DNA was above the detection limit. 4. Age: 18 - 65 years old. 5. PS/ECOG score (performance status score of 0 or 1). 6. Good organ function: a) Hematological: white blood cells >= 4000/µL, neutrophils >= 2000/µL, hemoglobin >= 9 g/dL, platelets >= 100,000/µL; b) Liver function: bilirubin = 3 g/dL; c) Renal function: serum creatinine = 60 mL/min according to the Cockcroft-Gault formula. d) Proteinuria: urine protein/creatinine ratio (UPC ratio) 0.5, further testing of 24-hour urine protein < 1000 mg is required for enrollment. Note: The UPC ratio of random urine is an estimate of 24-hour urine protein quantification, and the two have a good correlation. The UPC ratio can be calculated using the following formula: i. Urine protein/urine creatinine (if both protein and creatinine units are mg/dL) ii. (Urine protein) * 0.088/urine creatinine (if urine creatinine unit is mmol/L) e) Coagulation function: international normalized ratio (INR) <= 1.5, activated partial thromboplastin time (APTT) <= 1.5*ULN. 7. The patient has signed the informed consent form, is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures of the study plan.
Exclusion criteria
Exclusion criteria: 1. Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment. 2. Patients with a history of severe allergic reactions to other monoclonal antibodies or any components of PD-1/PD-L1 monoclonal antibodies. 3. Patients who achieved CR or PR after three courses of platinum-based chemotherapy combined with immunotherapy induction treatment. 4. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures. 5. Patients with recurrence, distant metastasis, or concurrent other malignancies. 6. Patients with severe heart disease, pulmonary dysfunction, or cardiac and pulmonary function below grade 3 (including grade 3). 7. Patients who have previously used anti-PD-1/PD-L1 antibodies or anti-CTLA-4 antibodies (or any other antibodies acting on T-cell co-stimulation or checkpoint pathways). 8. Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids at immunosuppressive doses before enrollment. 9. HIV-positive patients; patients with positive HBsAg and detectable HBV DNA copy number (quantitative detection >= 1000 cps/ml); patients with positive blood screening for chronic hepatitis C (HCV antibody positive). 10. Patients who have received chemotherapy, immunotherapy, targeted therapy, or surgery (excluding diagnostic treatment) for the primary lesion and/or cervical metastatic lesions. 11. Patients with a history of allergic reactions to the drugs in this study (gemcitabine, docetaxel, paclitaxel, cisplatin). 12. Patients with active tuberculosis (TB), currently receiving anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year before screening. 13. Patients who have received systemic or local glucocorticoid treatment, received any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.), or used traditional Chinese herbal medicines for anti-tumor purposes within 4 weeks before enrollment. 14. Pregnant women with positive pregnancy tests and lactating women. 15. Other patients deemed unsuitable for inclusion by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Quality of Life;Distant metastases-free survival (DMFS);Short-term efficacy indicators;Local regional recurrence-free survival (LRRFS);Safety indicators;Overall Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactChen mingyuan
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed