RecruitingNCT07232680

Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy

Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy

Sponsor

Cheng-En Hsieh

Enrollment

500 participants

Start Date

Nov 20, 2025

Study Type

OBSERVATIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)NPC Patients

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

Willingness to provide written informed consent.
Pathologically confirmed diagnosis of nasopharyngeal carcinoma
Age ≥18 years
ECOG performance status 0-1
Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy
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 Criteria6

Presence of distant metastasis
Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone.
Synchronous or prior invasive malignancy, unless disease-free for at least 2 years.
Prior radiotherapy to the head and neck region
Presence of severe major organ dysfunction
Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.

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Interventions

RADIATIONProton chemoradiotherapy

Concurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions.

RADIATIONPhoton chemoradiotherapy

Concurrent chemoradiotherapy will be delivered using photon-based volumetric modulated arc therapy, with a total dose of 69.96 Gy administered in 33 fractions.