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Lower-dose versus standard-dose radiation with concurrent chemoimmunotherapy for advanced nasopharyngeal cancer after a strong response to induction treatment

Reduced-Dose Versus Conventional-Dose Intensity-Modulated Radiation Therapy in Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy: A Multicenter, Phase III Clinical Trial

Phase 3 Interventional Sun Yat-sen University · NCT07328841

This trial tests whether giving lower-dose radiation alongside ongoing chemotherapy and immunotherapy works as well as standard-dose radiation for people with locally advanced nasopharyngeal cancer who had a strong response and undetectable EBV DNA after induction chemoimmunotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment456 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorSun Yat-sen University Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations12 sites (Guangzhou, Guangdong and 11 other locations)
Trial IDNCT07328841 on ClinicalTrials.gov

What this trial studies

Patients with stage IVa locally advanced non-keratinizing nasopharyngeal carcinoma who achieve a partial or complete response and have EBV DNA reduced to undetectable after three cycles of platinum-based induction chemotherapy combined with PD-1 blockade are randomized 1:1. One group receives reduced-dose intensity-modulated radiotherapy with concurrent chemotherapy and immunotherapy, and the other receives conventional-dose radiotherapy with the same concurrent treatment. The trial follows participants to compare 3-year progression-free survival, rates of severe (≥ grade 3) radiotherapy-related toxicities such as xerostomia, dysphagia, and hearing loss, and quality of life. The goal is to determine whether reduced-dose radiotherapy can maintain cancer control while lowering treatment-related harm.

Who should consider this trial

Good fit: Adults aged 18–70 with stage IVa non-keratinizing nasopharyngeal carcinoma who achieve partial or complete response on imaging and have EBV DNA reduced to undetectable after three cycles of platinum-based induction chemotherapy plus PD-1 blockade, with ECOG 0–1 and adequate organ function, are eligible.

Not a fit: Patients who do not clear EBV DNA after induction, have stable or progressive disease, poor performance status, or significant organ dysfunction are unlikely to benefit from a reduced-dose radiation approach.

Why it matters

Potential benefit: If successful, patients could maintain similar cancer control while experiencing fewer severe radiation-related side effects and better quality of life.

How similar studies have performed: Smaller and early-phase de-escalation studies in nasopharyngeal and other head-and-neck cancers guided by response or viral markers have shown promising toxicity reductions with preserved control, but randomized phase III evidence remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Histologically and/or cytologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO classification Type II or Type III).
2. Clinical stage: AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III).
3. After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, the efficacy is assessed as PR or CR by nasopharyngoscopy and enhanced MRI of nasopharynx + neck, with EBV DNA reduced to zero or below the lower limit of detection.
4. Age: 18-70 years old.
5. PS/ECOG score (performance status score of 0 or 1).
6. Adequate organ function:

   1. Hematology: White blood cell count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100000/μL;
   2. Liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible), AST and ALT ≤ 1.5 × ULN, and alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g/dL;
   3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula.
   4. Proteinuria: Urine protein/creatinine ratio (UPC ratio) \< 1.0. For those with UPC ratio ≤ 0.5, no further examination is required; for those with UPC ratio \> 0.5, further testing showing 24-hour urine protein \< 1000 mg is eligible.

   Note: The UPC ratio of random urine is an estimate of 24-hour urine protein quantification, and the two have a good correlation. The UPC ratio can be calculated using the following formulas:

   i. Urine protein/urine creatinine (if both protein and creatinine are in mg/dL); ii. (Urine protein) × 0.088/urine creatinine (if urine creatinine is in mmol/L).

   e) Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
7. Patients have signed the informed consent form and are willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Patients whose laboratory test results within 7 days before enrollment do not meet the relevant standards.
2. Patients with efficacy evaluation of stable disease (SD) or progressive disease (PD) after 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, or whose EBV DNA has not been reduced to zero or below the lower limit of detection.
3. Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment).
4. Patients with tumors accompanied by obvious liquefaction necrosis, which are unsuitable for radiotherapy or may lead to radioresistance.
5. Patients with tumors invading the brain parenchyma.
6. Patients with a history of severe allergic reactions to any components of other monoclonal antibodies or PD-1/PD-L1 monoclonal antibodies.
7. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
8. Patients with recurrence, distant metastasis, or concurrent other malignant tumors.
9. Patients with severe heart disease, pulmonary dysfunction, or cardiac/pulmonary function grade 3 or lower (including grade 3).
10. Patients with previous use of anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways.
11. Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic/local use of corticosteroids at immunosuppressive doses before enrollment.
12. Patients with HIV positivity; HBsAg positivity with positive HBV DNA copy number (quantitative detection ≥ 1000 cps/ml); positive screening for chronic hepatitis C (HCV antibody positivity).
13. Patients with a history of allergic reactions to the drugs used in this study (gemcitabine, docetaxel, taxanes, cisplatin).
14. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.
15. Patients who, within 4 weeks before enrollment: have received systemic or local glucocorticoid treatment, been vaccinated with any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.), or used traditional Chinese herbal medicines with anti-tumor effects.
16. Women of childbearing age with positive pregnancy test results and lactating women.
17. Other patients deemed unsuitable for inclusion by the attending physician.

Where this trial is running

Guangzhou, Guangdong and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nasopharyngeal CarcinomaLocally AdvancedEpstein-Barr Virus DNAEBV DNA clearanceundetectable EBV DNAreduced-dose radiotherapyRandomized non-inferiority trialConcurrent chemoradiotherapy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.