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Nasopharyngeal Carcinoma (NPC)Phase 3NCT07328841

Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy

A Phase 3 study testing Full course of PD-1blockades, Cisplatin-based induction chemotherapy and Standard-dose radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Ming-Yuan Chen at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response [CR]/partial response [PR] by imaging, with… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Full course of PD-1blockades, Cisplatin-based induction chemotherapy and Standard-dose radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
12 sitesChina
Study dates
18 Nov 2025to 30 Jun 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically and/or cytologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO classification Type II or Type III).
  • Clinical stage: AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III).
  • 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.
  • Age: 18-70 years old.
  • PS/ECOG score (performance status score of 0 or 1).
  • Adequate organ function:
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  • Hematology: White blood cell count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100000/μL;
  • 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;
  • Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula.
  • 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:
  • 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).
  • Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • 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

Who cannot join

  • Patients whose laboratory test results within 7 days before enrollment do not meet the relevant standards.
  • 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.
  • 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).
  • Patients with tumors accompanied by obvious liquefaction necrosis, which are unsuitable for radiotherapy or may lead to radioresistance.
  • Patients with tumors invading the brain parenchyma.
  • Patients with a history of severe allergic reactions to any components of other monoclonal antibodies or PD-1/PD-L1 monoclonal antibodies.
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  • Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
  • Patients with recurrence, distant metastasis, or concurrent other malignant tumors.
  • Patients with severe heart disease, pulmonary dysfunction, or cardiac/pulmonary function grade 3 or lower (including grade 3).
  • 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.
  • Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic/local use of corticosteroids at immunosuppressive doses before enrollment.
  • 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).
  • Patients with a history of allergic reactions to the drugs used in this study (gemcitabine, docetaxel, taxanes, cisplatin).
  • Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.
  • 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.
  • Women of childbearing age with positive pregnancy test results and lactating women.
  • Other patients deemed unsuitable for inclusion by the attending physician.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ming-Yuan Chen, MD,PhD contact

+86-20-87343361

chenmy@sysucc.org.cn

Rui You, MD,PhD contact

+86-13580439820

your5@mail.sysu.edu.cn

12 sites in 1 country

China12 sites, 12 recruiting

  • Central South University Cancer Hospital

    Changsha, Hunan

    Yaqian Han, +86-18673176667, hanyaqian@hnca.org.cn

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    Yuxiang He, +86-13786112914, heyuxiang88@163.com

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Guangdong, Zhuhai, 519000

    Ming-Yuan Chen, MD,PhD, +86-13903052650, chenmy@sysucc.org.cn

    Recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 516000

    Mingyuan Chen, PhD., +86-13878480806, chmingy@mail.sysu.edu.cn

    Recruiting

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong

    Bin Qi, +86-13580580985

    Recruiting

  • Sun Yat-sen University cancer center

    Guangzhou, Guangdong

    Peiyu Huang, +86-13632396200, huangpy@sysucc.org.cn

    Recruiting

  • The Second Affiliated Hospital of Sun Yat-sen University (SYSU)

    Guangzhou, Guangdong

    Yimin Liu, +86-13802501812

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

    Shen-Hong Qu, MD, PhD, +86-15807813816, qshdoctor@163.com

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong

    Kai Chen, +86-13005222990, chenkai89@126.com

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Guangyuan Hu, +86-13886000095

    Recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi

    Jinhui Liang, +86-13878480806

    Recruiting

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong

    Feng Lei, +86-13528227676

    Recruiting

Other trials in China

About this study

Official title: 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

To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response [CR]/partial response [PR] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.

Read the detailed description

In a prospective clinical trial, under full-course immunotherapy, a platinum-based chemotherapy combined with immunotherapy regimen is used as the induction treatment protocol. Patients with stage Ⅳa (AJCC 8th,) nasopharyngeal carcinoma who achieve partial response (PR) or complete response (CR) after induction treatment, with EBV DNA reduced to zero or below the lower limit of detection, are randomized at a 1:1 ratio. One group receives reduced-dose radiotherapy combined with concurrent chemoimmunotherapy, while the other group receives conventional-dose radiotherapy combined with concurrent chemoimmunotherapy.

Through follow-up, the differences in survival prognosis, incidence of complications, and quality of life between the two groups are observed. The aim is to evaluate whether, on the premise of ensuring non-inferior 3-year progression-free survival (PFS), reduced-dose radiotherapy shows superiority or significant improvement in ≥ grade 3 radiotherapy-related toxicities (especially xerostomia, dysphagia, and hearing loss) and quality of life. Thereby, it explores whether the treatment strategy of further reduced-dose radiotherapy is suitable for patients with locally advanced nasopharyngeal carcinoma who achieve CR/PR on imaging evaluation and have EBV DNA reduced to zero after neoadjuvant therapy.

Being tested
Full course of PD-1blockades, Cisplatin-based induction chemotherapy, Standard-dose radiotherapy, Reduced-dose radiotherapy, Concurrent Chemotherapy
Keywords
Nasopharyngeal Carcinoma, Locally Advanced, Epstein-Barr Virus DNA, EBV DNA clearance, undetectable EBV DNA, reduced-dose radiotherapy, Randomized non-inferiority trial, Concurrent chemoradiotherapy, complete response, partial response, PD-1inhibitor
Medical subject headings
Nasopharyngeal Carcinoma, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full course of PD-1blockadesDrug

    Toripalimab 240 mg, once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.

  • Cisplatin-based induction chemotherapyDrug

    Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

  • Standard-dose radiotherapyRadiation

    GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy

  • Reduced-dose radiotherapyRadiation

    GTVnx/nd:63.6Gy/30Fr/2.12Gy CTV1: 54Gy/30Fr/1.8Gy CTV2: 49.2Gy/30Fr/1.64Gy

  • Concurrent ChemotherapyDrug

    Cisplatin 100mg/m2 every 3 weeks for 2 cycles

Study groups in NCT07328841
Study groupRoleWhat they receive
Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapyExperimentalNot described
Receives: Drug: Full course of PD-1blockades; Drug: Cisplatin-based induction chemotherapy; Radiation: Reduced-dose radiotherapy; Drug: Concurrent Chemotherapy
Induction chemotherapy plus conventional concurrent chemoradiotherapyActive comparatorNot described
Receives: Drug: Full course of PD-1blockades; Drug: Cisplatin-based induction chemotherapy; Radiation: Standard-dose radiotherapy; Drug: Concurrent Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progress-Free Survival (PFS)

    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

    Measured: 3 years

Secondary outcomes (8)

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Measured: 3 years

  2. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from randomisation to the date of first locoregional relapse.

    Measured: 3 years

  3. Distant Metastasis-Free Survival (DMFS)

    Defined as the time interval from randomisation to the date of first distant metastases.

    Measured: 3 years

  4. Objective Response Rate (ORR)

    Defined as the proportion of patients with tumor reduction achieving complete response (CR) or partial response (PR), assessed at 3 months after the end of concurrent chemoradiotherapy.

    Measured: assessed at 3 months after the end of concurrent chemoradiotherapy

  5. The proportion of patients with treatment related acute complications

    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: 1 year

  6. The proportion of patients with treatment related late complications

    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: 3 years

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

    Measured: 3 years

  8. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start18 Nov 2025
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328841
Sponsor's protocol ID
ZDWY.BYAFZZX.043
Status last verified
Dec 2025
First submitted
27 Dec 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Full course of PD-1blockades, Cisplatin-based induction chemotherapy and Standard-dose radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Ming-Yuan Chen at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-Yuan Chen, MD,PhD (+86-20-87343361, chenmy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07328841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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