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Nasopharyngeal CarcinomaPhase 3NCT06239727

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

A Phase 3 study testing PD-1 blocking antibody, Gemcitabine and Cisplatin (80 mg/m2) in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 26 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

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
PD-1 blocking antibody, Gemcitabine and Cisplatin (80 mg/m2)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
593 participants
Where
26 sitesChina
Study dates
1 Mar 2024to 20 Feb 2030
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 Years to 65 Years;
  • Eastern Cooperative Oncology Group performance status ≤1;
  • Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma;
  • Tumor staged as Stage III (T3N0 Excepted; AJCC 8th);
  • Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion);
  • Normal bone marrow function: white blood cell count > 4×10^9/L, hemoglobin > 90g/L, platelet count > 100×10^9/L;
Show all 12Show fewer
  • 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;
  • Receive 3 cycles of indction chemotherapy (GP regimen + Camrelizumab);
  • Plasma EBV DNA after the second cycle of concurrent chemotherapy: negative;
  • 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);
  • 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;
  • Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Who cannot join

  • Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA > 1000 copies/ml;
  • Anti-hepatitis C virus positive;
  • Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
  • 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;
  • 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);
  • Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
Show all 17Show fewer
  • 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;
  • 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;
  • Active infection requiring systemic treatment;
  • Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
  • History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma;
  • Receive treatment for the local or regional disease other than that specified in the research plan;
  • Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
  • Allergy to macromolecular protein preparations, or any component of Camrelizumab;
  • Receiving live vaccine within 30 days of the initial Camrelizumab;
  • Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast;
  • 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.

Trial locations and contacts

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

Jun Ma contact

+862087343469

majun2@mail.sysu.edu.cn

Kai-Bin Yang contact

+8613725368062

yangkb@sysucc.org.cn

26 sites in 1 country

China26 sites, 26 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Ya-Qian Han, hanyaqiancs@163.com

    Ya-qian Han

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Liang-Fang Shen, MD, slf1688@sina.com

    Liang-Fang Shen

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Shi-Chuan Zhang

    Shi-Chuan Zhang

    Recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Nian-Yong Chen

    Lei Liu

    Recruiting

  • Chongqing Cancer Hospital

    Chongqing

    Ying Wang

    Ying Wang

    Recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Zhi-Gang Liu

    Zhi-Gang Liu

    Recruiting

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

    Gui-Chao Liu, 8618038865028, 490690@qq.com

    Gui-Chao Liu

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Chuan-Ben Chen

    Chuan-Ben Chen

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Jun Ma, +862087343469, majun2@mail.sysu.edu.cn

    Kai-Bin Yang, +8613725368062, yangkb@sysucc.org.cn

    Recruiting

  • The Affiliated Panyu Central Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511400

    Guo-Rong Zou

    Guo-Rong Zou

    Recruiting

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Feng Jin, MD, jinf8865@yeah.net

    Feng Jin

    Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

    Yue-Can Zeng

    Yue-Can Zeng

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Xiao-Zhong Chen

    Xiao-Zhong Chen

    Recruiting

  • Jiangxi Cancer Center

    Nanchang, Jiangxi

    Jin-Gao Li

    Xiao-Chang Gong

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Li Yin

    Li Yin

    Recruiting

  • Jiangsu Provinee Hospital of Chinese Medicine

    Nanjing, Jiangsu

    Jing Yan

    Jing Yan

    Recruiting

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi

    Xiao-Dong Zhu, MD, zhuxiaodong83@163.com

    Xiao-Dong Zhu

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong

    Chuang-Zhen Chen

    Chuang-Zhen Chen

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Pei-Guo Wang

    Pei-Guo Wang

    Recruiting

  • Hubei Province Cancer Hosiptal

    Wuhan, Hubei

    De-Sheng Hu, M.D., hds_005@163.com

    De-Sheng Hu

    Recruiting

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

    Wuhan, Hubei

    Guang-Yuan Hu

    Guang-Yuan Hu

    Recruiting

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

    Wuhan, Hubei

    Kun-Yu Yang, MD, yangkunyu@medmail.com.cn

    Kun-Yu Yang

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    San-Gang Wu

    San-Gang Wu

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xian, Shanxi

    Rui Liu

    Rui Liu

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

    Hai-Qing Luo

    Hai-Qing Luo

    Recruiting

  • Guangdong Nongken Central Hospital

    Zhanjiang, Guangdong

    Rui-Wen Huang

    Rui-Wen Huang

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
PD-1 blocking antibody, Gemcitabine, Cisplatin (80 mg/m2), Reduced-dose Intensity-modulated radiotherapy, Conventional-dose Intensity-modulated radiotherapy
Keywords
Radiotherapy, Dose, PD-1, Immune Checkpoint Inhibitor, Capecitabine, Quality of Life, Personalised Therapy, Complication, Deintensification
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • PD-1 blocking antibodyDrug

    Also called Camrelizumab

    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.

  • GemcitabineDrug

    Also called GEM

    Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

  • Cisplatin (80 mg/m2)Drug

    Also called DDP

    Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

  • Reduced-dose Intensity-modulated radiotherapyRadiation

    Also called Reduced-dose IMRT

    1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day
    2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

  • Conventional-dose Intensity-modulated radiotherapyRadiation

    Also called Conventional-dose IMRT

    1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day
    2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

  • Cisplatin (100 mg/m2)Drug

    Also called DDP

    Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

  • CapecitabineDrug

    Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Study groups in NCT06239727
Study groupRoleWhat they receive
Reduced-dose radiotherapy groupExperimentalAll 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.
Receives: Drug: PD-1 blocking antibody; Drug: Gemcitabine; Drug: Cisplatin (80 mg/m2); Radiation: Reduced-dose Intensity-modulated radiotherapy; Drug: Cisplatin (100 mg/m2)
Conventional-dose radiotherapy groupActive comparatorAll 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.
Receives: Drug: PD-1 blocking antibody; Drug: Gemcitabine; Drug: Cisplatin (80 mg/m2); Radiation: Conventional-dose Intensity-modulated radiotherapy; Drug: Cisplatin (100 mg/m2)
Not-Randomized populationOtherAll 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.
Receives: Drug: PD-1 blocking antibody; Drug: Gemcitabine; Drug: Cisplatin (80 mg/m2); Radiation: Conventional-dose Intensity-modulated radiotherapy; Drug: Cisplatin (100 mg/m2); Drug: Capecitabine

What is being measured

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

  1. Locoregional failure-free survival (LRFFS)

    Locoregional failure-free survival is measured from day of diagnosis until local or regional recurrence.

    Measured: 3-year

Secondary outcomes (8)

  1. Overall survival (OS)

    Overall survival is measured from day of diagnosis until death from any cause.

    Measured: 3 year

  2. Failure-free survival (FFS)

    Failure-free survival is measured from day of diagnosis until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurred first.

    Measured: 3 year

  3. Distant failure-free survival (DFFS)

    Distant failure-free survival is measured from day of diagnosis until distant failure.

    Measured: 3 year

  4. Local failure-free survival (LFFS)

    Local failure-free survival is measured from day of diagnosis until local recurrence.

    Measured: 3 year

  5. Regional failure-free survival (RFFS)

    Regional failure-free survival is measured from day of diagnosis until regional recurrence.

    Measured: 3 year

  6. Incidence rate of investigator-reported radiotherapy-related complications

    Measured: Within (acute complication) / since (late complication) 90 days after the radiotherapy onset.

  7. Incidence rate of patient-reported adverse events

    Measured: 3 year

  8. Quality of life (QoL): questionnaire

    Measured: Regular evaluation after 30 fractions of radiotherapy.

Timeline

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

  1. First posted2 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2030 (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
593 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06239727
Sponsor's protocol ID
2023-FXY-204-FLK
Status last verified
Mar 2026
First submitted
26 Jan 2024
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.

    PubMed 29584545

  • Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.

    PubMed 28837405

  • Fang W, Yang Y, Ma Y, Hong S, Lin L, He X, Xiong J, Li P, Zhao H, Huang Y, Zhang Y, Chen L, Zhou N, Zhao Y, Hou X, Yang Q, Zhang L. Camrelizumab (SHR-1210) alone or in combination with gemcitabine plus cisplatin for nasopharyngeal carcinoma: results from two single-arm, phase 1 trials. Lancet Oncol. 2018 Oct;19(10):1338-1350. doi: 10.1016/S1470-2045(18)30495-9. Epub 2018 Sep 10.

    PubMed 30213452

  • Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021 Mar 1;39(7):704-712. doi: 10.1200/JCO.20.02712. Epub 2021 Jan 25.

    PubMed 33492986

  • Li XY, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Liu LT, Yang ZC, Yang JH, Qiu F, Sun XS, Wang P, Liu Q, Li JB, Tang QN, Lin C, Yang Q, Liu SL, Liang YJ, Jia GD, Wen DX, Guo CY, Yan JJ, Zhao C, Chen QY, Tang LQ, Mai HQ. Deintensified Chemoradiotherapy for Pretreatment Epstein-Barr Virus DNA-Selected Low-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Noninferiority Trial. J Clin Oncol. 2022 Apr 10;40(11):1163-1173. doi: 10.1200/JCO.21.01467. Epub 2022 Jan 6.

    PubMed 34990291

  • Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. doi: 10.1001/jama.2022.13997.

    PubMed 35997729

  • Tang LL, Huang CL, Zhang N, Jiang W, Wu YS, Huang SH, Mao YP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Sun Y, Xie FY, Chen L, Zhou GQ, Ma J. Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial. Lancet Oncol. 2022 Apr;23(4):479-490. doi: 10.1016/S1470-2045(22)00058-4. Epub 2022 Feb 28.

    PubMed 35240053

  • Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.

    PubMed 36746459

  • Guo SS, Yang JH, Sun XS, Liu LZ, Yang ZC, Liu LT, Liu SL, Li XY, Lv XF, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Sun R, Yang Q, Liang YJ, Jia GD, Zhao C, Chen QY, Tang LQ, Mai HQ. Reduced-dose radiotherapy for Epstein-Barr virus DNA selected staged III nasopharyngeal carcinoma: A single-arm, phase 2 trial. Eur J Cancer. 2023 Nov;194:113336. doi: 10.1016/j.ejca.2023.113336. Epub 2023 Sep 9.

    PubMed 37801967

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PD-1 blocking antibody, Gemcitabine and Cisplatin (80 mg/m2) in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 26 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 12 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 Jun Ma (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locoregional failure-free survival (LRFFS) (time frame: 3-year). 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 NCT06239727, which also lists 9 linked publications.

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 6 Mar 2026.

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