Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or P
To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.
| Condition(s) | NPC Patients, Nasopharyngeal Cancinoma (NPC) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes. |
| Who can participate | Inclusion Criteria: 1. Willingness to provide written informed consent. 2. Pathologically confirmed diagnosis of nasopharyngeal carcinoma 3. Age ≥18 years 4. ECOG performance status 0-1 5. Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy 6. Adequate bone marrow, liver, and renal function within 4 weeks before study registration * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 50,000/μL * Total bilirubin \< 2.5 mg/dL * Serum albumin \>2.8 g/dL * Serum creatinine ≤ 1.5 mg/dL Exclusion Criteria: 1. Presence of distant metastasis 2. Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone. 3. Synchronous or prior invasive malignancy, unless disease-free for at least 2 years. 4. Prior radiotherapy to the head and neck |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cheng-En Hsieh |
| Locations | Taoyuan City, Taiwan, Taiwan |
| Start date | 2025-11-20 |
| NCT ID | NCT07232680 |
| Official listing | https://clinicaltrials.gov/study/NCT07232680 |