Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

March 4, 2026 updated by: Jun Ma, MD, Sun Yat-sen University

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response: an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial

This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goals of this clinical trial includes: ① To confirm whether LRRFS after reduced-dose radiotherapy in combination with chemotherapy and immunotherapy is non-inferior to LRRFS after conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response; ② To explore the impact of reduced-dose radiotherapy on 3-year OS, 3-year PFS, 3-year DMFS, 3-year LRFS and 3-year RRFS for treatment-sensitive stage III NPC patients screened out according to the treatment response; ③ To explore the impact of reduced-dose radiotherapy on radiotherapy complications and quality of life; ④ To explore the interaction between different clinical factors and the impact of reduced-dose radiotherapy on the prognosis of patients; ⑤ To explore the biomarkers of sensitivity to chemotherapy and radiotherapy for patients with nasopharyngeal carcinoma and the underlying mechanism.

For these purposes, we plan to prospectively enroll stage III NPC patients from hospitals in China. The participants will receive 3 cycles of induction chemotherapy (GP regimen + Camrelizumab) followed by intensity-modulated radiation therapy. 2 cycles of concurrent chemotherapy will be administered during the radiotherapy. Patients' treatment response will be evaluated with MRI examination after 27 fractions of radiotherapy. If the treatment response after 27 fractions of radiotherapy is complete remission, the participants will be randomized into reduced-dose radiotherapy group and conventional-dose radiotherapy group. If the treatment response after 27 fractions of radiotherapy is not complete remission, the participants will be assigned to the unenrolled group. All the participants in the unenrolled group will receive conventional-dose radiotherapy. After the radiotherapy, all the participants will receive 9 cycles of Camrelizumab immunotherapy. Besides, all the participants in the unenrolled group will also receive metronomic adjuvant capecitabine chemotherapy for 1 year. The prognosis, complication, and quality of life will be compared between the reduced-dose radiotherapy group and the conventional-dose radiotherapy group.

Study Type

Interventional

Enrollment (Estimated)

593

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Ying Wang
        • Principal Investigator:
          • Ying Wang
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Pei-Guo Wang
        • Principal Investigator:
          • Pei-Guo Wang
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Chuan-Ben Chen
        • Principal Investigator:
          • Chuan-Ben Chen
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • San-Gang Wu
        • Principal Investigator:
          • San-Gang Wu
    • Guangdong
      • Dongguan, Guangdong, China
        • Recruiting
        • Dongguan People's Hospital
        • Contact:
          • Zhi-Gang Liu
        • Principal Investigator:
          • Zhi-Gang Liu
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
        • Principal Investigator:
          • Gui-Chao Liu
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Jun Ma
        • Contact:
        • Sub-Investigator:
          • Kai-Bin Yang
      • Guangzhou, Guangdong, China, 511400
        • Recruiting
        • The Affiliated Panyu Central Hospital of Guangzhou Medical University
        • Contact:
          • Guo-Rong Zou
        • Principal Investigator:
          • Guo-Rong Zou
      • Shantou, Guangdong, China
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
          • Chuang-Zhen Chen
        • Principal Investigator:
          • Chuang-Zhen Chen
      • Zhanjiang, Guangdong, China
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Hai-Qing Luo
        • Principal Investigator:
          • Hai-Qing Luo
      • Zhanjiang, Guangdong, China
        • Recruiting
        • Guangdong Nongken Central Hospital
        • Contact:
          • Rui-Wen Huang
        • Principal Investigator:
          • Rui-Wen Huang
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Cancer Hospital of Guangxi Medical University
        • Contact:
        • Principal Investigator:
          • Xiao-Dong Zhu
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Cancer Hospital of Guizhou Medical University
        • Principal Investigator:
          • Feng Jin
        • Contact:
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
          • Yue-Can Zeng
        • Principal Investigator:
          • Yue-Can Zeng
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Kun-Yu Yang
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Guang-Yuan Hu
        • Principal Investigator:
          • Guang-Yuan Hu
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Province Cancer Hosiptal
        • Contact:
        • Principal Investigator:
          • De-Sheng Hu
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Ya-qian Han
        • Sub-Investigator:
          • Feng Liu
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Principal Investigator:
          • Liang-Fang Shen
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Li Yin
        • Principal Investigator:
          • Li Yin
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Provinee Hospital of Chinese Medicine
        • Contact:
          • Jing Yan
        • Principal Investigator:
          • Jing Yan
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Center
        • Contact:
          • Jin-Gao Li
        • Contact:
          • Xiao-Chang Gong
        • Principal Investigator:
          • Jin-Gao Li
        • Sub-Investigator:
          • Xiao-Chang Gong
    • Shanxi
      • Xian, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xian Jiaotong University
        • Contact:
          • Rui Liu
        • Principal Investigator:
          • Rui Liu
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Shi-Chuan Zhang
        • Principal Investigator:
          • Shi-Chuan Zhang
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital,Sichuan University
        • Contact:
          • lei Liu
        • Contact:
          • Nian-Yong Chen
        • Principal Investigator:
          • Nian-Yong Chen
        • Sub-Investigator:
          • Lei Liu
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Xiao-Zhong Chen
        • Principal Investigator:
          • Xiao-Zhong Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18 Years to 65 Years;
  2. Eastern Cooperative Oncology Group performance status ≤1;
  3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;
  4. Tumor staged as Stage III (T3N0 Excepted; AJCC 8th);
  5. Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion);
  6. Normal bone marrow function: white blood cell count > 4×10^9/L, hemoglobin > 90g/L, platelet count > 100×10^9/L;
  7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate transaminase ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, creatinine clearance rate ≥ 60 ml/min;
  8. Receive 3 cycles of indction chemotherapy (GP regimen + Camrelizumab);
  9. Plasma EBV DNA after the second cycle of concurrent chemotherapy: negative;
  10. Complete remission after 27 fractions of radiotherapy based on the MRI examination of the nasopharynx and neck (According to Response Evaluation Criteria in Solid Tumors 1.1);
  11. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
  12. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Exclusion Criteria:

  1. Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA > 1000 copies/ml;
  2. Anti-hepatitis C virus positive;
  3. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
  4. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;
  5. Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
  6. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
  7. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
  8. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
  9. Active infection requiring systemic treatment;
  10. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
  11. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma;
  12. Receive treatment for the local or regional disease other than that specified in the research plan;
  13. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
  14. Allergy to macromolecular protein preparations, or any component of Camrelizumab;
  15. Receiving live vaccine within 30 days of the initial Camrelizumab;
  16. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast;
  17. History of psychotropic disease, alcoholism or drug abuse, and other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduced-dose radiotherapy group
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by reduced-dose intensity-modulated radiation therapy (IMRT; 6360cGy, 30 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.
Drug: PD-1 blocking antibody
  1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
  2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.
Other Names:
  • Camrelizumab
Drug: Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • GEM
Drug: Cisplatin (80 mg/m2)
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • DDP
Radiation: Reduced-dose Intensity-modulated radiotherapy
  1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day
  2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.
Other Names:
  • Reduced-dose IMRT
Drug: Cisplatin (100 mg/m2)
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Other Names:
  • DDP
Active Comparator: Conventional-dose radiotherapy group
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles.
Drug: PD-1 blocking antibody
  1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
  2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.
Other Names:
  • Camrelizumab
Drug: Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • GEM
Drug: Cisplatin (80 mg/m2)
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • DDP
Drug: Cisplatin (100 mg/m2)
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Other Names:
  • DDP
Radiation: Conventional-dose Intensity-modulated radiotherapy
  1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
  2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.
Other Names:
  • Conventional-dose IMRT
Other: Not-Randomized population
All participants will receive induction chemotherapy and immunotherapy (every 3 weeks × 3 cycles of gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1 + camrelizumab 200 mg day 1) followed by conventional-dose intensity-modulated radiation therapy (IMRT; 6996cGy, 33 fractions, 5 fractions/week, 1 fraction/day). During the radiotherapy, all the participants will receive concurrent chemotherapy (every 3 weeks × 2 cycles of cisplatin 100 mg/m2 day 1). After 3 weeks of the completion of concurrent chemoradiotherapy, adjuvant camrelizumab (200 mg per cycle) will be administrated every 3 weeks for 9 cycles. Besides, all the participants should also receive metronomic adjuvant capecitabine chemotherapy (capecitabine 650 mg/m2 p.o. BID 1 year) immediately after the completion of concurrent chemoradiotherapy.
Drug: PD-1 blocking antibody
  1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
  2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.
Other Names:
  • Camrelizumab
Drug: Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • GEM
Drug: Cisplatin (80 mg/m2)
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Other Names:
  • DDP
Drug: Cisplatin (100 mg/m2)
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
Other Names:
  • DDP
Radiation: Conventional-dose Intensity-modulated radiotherapy
  1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
  2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.
Other Names:
  • Conventional-dose IMRT
Drug: Capecitabine
Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional failure-free survival (LRFFS)
Time Frame: 3-year
Locoregional failure-free survival is measured from day of diagnosis until local or regional recurrence.
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 3 year
Overall survival is measured from day of diagnosis until death from any cause.
3 year
Failure-free survival (FFS)
Time Frame: 3 year
Failure-free survival is measured from day of diagnosis until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurred first.
3 year
Distant failure-free survival (DFFS)
Time Frame: 3 year
Distant failure-free survival is measured from day of diagnosis until distant failure.
3 year
Local failure-free survival (LFFS)
Time Frame: 3 year
Local failure-free survival is measured from day of diagnosis until local recurrence.
3 year
Regional failure-free survival (RFFS)
Time Frame: 3 year
Regional failure-free survival is measured from day of diagnosis until regional recurrence.
3 year
Incidence rate of investigator-reported radiotherapy-related complications
Time Frame: Within (acute complication) / since (late complication) 90 days after the radiotherapy onset.
Within (acute complication) / since (late complication) 90 days after the radiotherapy onset.
Incidence rate of patient-reported adverse events
Time Frame: 3 year
3 year
Quality of life (QoL): questionnaire
Time Frame: Regular evaluation after 30 fractions of radiotherapy.
Regular evaluation after 30 fractions of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jun Ma, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2030

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-FXY-204-FLK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Complete de-identified patient data set will be submitted onto the Research Data Deposit (RDD) public platform (http://www.researchdata.org.cn) and available from the principal investigators upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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