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

NCT07232680 | Recruiting FDA Device

• 1 other identifier: 202501031A3
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

NPC Patients; Nasopharyngeal Cancinoma (NPC)

Keywords

NPC; proton radiotherapy; photon radiotherapy; proton beam therapy; IMPT; IMRT; IMAT; chemoradiation; Immune response; Radiomics

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival is defined as the time from signing the informed consent to death from any cause.

  2 years

Secondary Outcomes (3)

• Progression free survival

  2 years

• Time to progression

  2 years

• Incidence and severity of adverse events

  5 years

Other Outcomes (2)

• Changes of myeloid-derived suppressor cell levels

  4 months

• Changes in MRI radiomic parameters

  4 months

Study Arms (2)

Proton chemoradiotherapy

Proton chemoradiotherapy: 69.96 cobalt Gray equivalent (CGE) in 33 fractions

Radiation: Proton chemoradiotherapy

Photon chemoradiotherapy

Photon chemoradiotherapy: 69.96 Gy in 33 fractions

Radiation: Photon chemoradiotherapy

Interventions

Proton chemoradiotherapy RADIATION

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

Proton chemoradiotherapy

Photon chemoradiotherapy RADIATION

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

Photon chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AJCC 9th edition stage I-III nasopharyngeal carcinoma undergoing definitive chemoradiotherapy using either proton or photon radiotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng-En Hsieh: lead

Study Sites (1)

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (including plasma and cellular components) will be collected at baseline, 6-8 weeks, and 3-4 months after the initiation of radiotherapy.

Study Officials

• Rodney Cheng En Hsieh, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodney Cheng-En Hsieh, MD, PhD

CONTACT

+886-3-328-1200; rodney445@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): August 15, 2031
• Study Completion (Estimated): August 15, 2034
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)