NCT07232680 Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy
| NCT ID | NCT07232680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cheng-En Hsieh |
| Condition | NPC Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2031-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-11-20 with a primary completion date of 2031-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Rodney Cheng En Hsieh, MD, PhD
PRINCIPAL INVESTIGATOR
Chang Gung Memorial Hospital
Frequently Asked Questions
Who can join the NCT07232680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NPC Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07232680 currently recruiting?
Yes, NCT07232680 is actively recruiting participants. Contact the research team at rodney445@gmail.com for enrollment information.
Where is the NCT07232680 trial being conducted?
This trial is being conducted at Taoyuan City, Taiwan.
Who is sponsoring the NCT07232680 clinical trial?
NCT07232680 is sponsored by Cheng-En Hsieh. The principal investigator is Rodney Cheng En Hsieh, MD, PhD at Chang Gung Memorial Hospital. The trial plans to enroll 500 participants.