nasopharyngeal carcinoma
Conditions
Interventions
Single-arm group:Tiralizumab
Sponsors
Shanghai Proton and Heavy Ion Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-70 years; 2.Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma; 3.Staged as T4 and/or N3 according to the UICC/AJCC 8th edition staging system for head and neck tumors; 4.Distant metastasis excluded by systemic examination (whole-body PET/CT, or chest CT plain scan + abdominal ultrasound + bone scan); 5.No prior chemotherapy, immunotherapy (including but not limited to anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), or other tumor ablation therapies (including interventional therapy, cryotherapy, radiofrequency ablation, and any form of local or systemic treatment) since diagnosis of nasopharyngeal carcinoma; 6.Able to undergo MRI (preferred) or contrast-enhanced CT examination; 7.Adequate function of major organs (hematopoietic, hepatic, and renal) to meet the requirements for radiotherapy, chemotherapy, and immunotherapy: (1) Hematopoietic function: Hemoglobin >=9 g/L, Platelets >=100 × 10^9/L, White blood cells >=3.5 × 10^9/L, Neutrophils >=2.0 × 10^9/L (2) Hepatic function: ALT and AST =50 mL/min (for adults) or serum creatinine within normal range (4) If the patient has clinical symptoms, the decision should be based on the specific clinical manifestations. 8.ECOG performance status 0-1 (see Appendix I for evaluation criteria); without severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that may affect radiotherapy. Cardiac function class 1-2 (according to the New York Heart Association (NYHA) classification). 9.Expected survival period >=12 months; 10.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pathological confirmation of WHO Type I, II, or III nasopharyngeal carcinoma is not obtained; 2.AJCC clinical stage I-III, or pre-treatment clinical or radiological evidence of distant metastasis; 3.Pregnancy (confirmed by serum or urine ß-HCG test) or breastfeeding females; 4.Unwillingness to sign the informed consent form; 5.Prior radiotherapy to the head and neck region (including but not limited to one or more sessions of conventional photon radiotherapy, one or more sessions of proton or carbon ion therapy, radioactive seed implantation, or any other form of radiotherapy); 6.Presence of other diseases or factors that may potentially interfere with photon or carbon ion therapy; 7.Inability to comply with scheduled follow-up due to psychological, social, familial, or geographical reasons; 8.Concurrent participation in the treatment phase of another clinical research study involving investigational therapies; 9.Known allergy to cisplatin, docetaxel, or tislelizumab; known allergy to contrast agents used in imaging studies related to this research; 10.Presence of severe uncontrolled infection or medical illness; 11.Dysfunction of major organs (e.g., decompensated heart, lung, kidney, or liver failure) rendering the patient unable to tolerate chemotherapy; 12.History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation. 13.History of other malignant tumors prior to enrollment (except for basal cell carcinoma of the skin); 14.History of drug abuse or alcohol dependence; 15.Any other condition deemed by the investigator as potentially leading to forced discontinuation from the study, such as other severe diseases (including mental illness) requiring concomitant treatment, severely abnormal laboratory values, or familial/social factors that may compromise subject safety or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Locoregional Recurrence-Free Survival;Distant Metastasis-Free Survival;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactChaosu Hu
Shanghai Proton and Heavy Ion Hospital
Outcome results
None listed