Immuno-radiomic profiling for nasopharyngeal cancer treated with proton or photon chemoradiotherapy
Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy
We will test if combining imaging-based radiomic features with immune markers can help predict treatment response, side effects, and long-term outcomes for adults with stage I–III nasopharyngeal cancer receiving proton or photon chemoradiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Taoyuan City, Taiwan) |
| Trial ID | NCT07232680 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized, single-center phase II protocol enrolling adults with AJCC v.9 stage I–III nasopharyngeal carcinoma who will receive definitive chemoradiotherapy with either proton or photon techniques. Patients will undergo standardized radiotherapy target delineation per international consensus and receive concurrent cisplatin-based chemotherapy when indicated. Longitudinal radiomic (imaging) and immunologic (blood/tissue) biomarkers will be collected before, during, and after treatment, with clinical follow-up for at least two years to capture response, toxicity, and survival outcomes. The goal is to integrate imaging and immune signatures to identify biomarkers associated with treatment efficacy and adverse effects.
Who should consider this trial
Good fit: Adults (≥18 years) with pathologically confirmed AJCC v.9 stage I–III nasopharyngeal carcinoma, ECOG 0–1, adequate organ function, and planned definitive proton or photon chemoradiotherapy are the intended candidates.
Not a fit: Patients with distant metastases, prior head and neck radiotherapy, very early-stage disease treated without chemoradiotherapy, significant major organ dysfunction, or who cannot comply with follow-up (including pregnant women unwilling to use contraception) are excluded and unlikely to benefit from the protocol.
Why it matters
Potential benefit: If successful, the project could help doctors predict who will respond well or develop toxicities and guide more personalized radiotherapy choices for nasopharyngeal cancer patients.
How similar studies have performed: Similar radiomic and immune-biomarker approaches have shown promising signals in small or retrospective head-and-neck and nasopharyngeal cancer cohorts, but prospective validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 region 5. Presence of severe major organ dysfunction 6. Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.
Where this trial is running
Taoyuan City, Taiwan
- Chang Gung Memorial Hospital at Linkou — Taoyuan City, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Rodney Cheng En Hsieh, MD, PhD — Chang Gung Memorial Hospital
- Study coordinator: Rodney Cheng-En Hsieh, MD, PhD
- Email: rodney445@gmail.com
- Phone: +886-3-328-1200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.