Immuno-radiomic profiling for nasopharyngeal cancer treated with proton or photon chemoradiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.