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Non-metastatic Nasopharyngeal CarcinomaPhase 3CTV-MARGIN-NPCNCT07661771

Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma

A Phase 3 study testing Comprehensive Therapy Based on Tumor Stage, IMRT with Primary Clinical Target Volume Based on Margin Expansion and IMRT with Consensus Primary Clinical Target Volume in people with Non-metastatic Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 7 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 a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-metastatic Nasopharyngeal Carcinoma
What is being tested?
Comprehensive Therapy Based on Tumor Stage, IMRT with Primary Clinical Target Volume Based on Margin Expansion and IMRT with Consensus Primary Clinical Target Volume
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
568 participants
Where
7 sitesChina
Study dates
24 Jul 2026to 30 Jul 2034
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 (non-keratinizing subtype).
  • Tumor staged as T1-4N0-3M0 (AJCC 9th).
  • 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.
  • Women of childbearing potential and male subjects with female partners of childbearing potential must agree to use reliable contraceptive measures from screening to 1 year after treatment.
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  • For subjects requiring chemotherapy, the following are additionally required:
  • normal bone marrow function (white blood cell count > 4 × 10^9/L, hemoglobin > 90 g/L, platelet count > 100 × 10^9/L);
  • normal liver and kidney function (total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2.5 × upper limit of normal, alkaline phosphatase ≤ 2.5 × upper limit of normal, creatinine clearance rate ≥ 60 mL/min).

Who cannot join

  • Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis > 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.
  • 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.
  • Prior or concurrent treatment for local or regional disease other than that specified in the research plan.
  • Pregnant or lactating women (a pregnancy test is required for women of childbearing potential).
Show all 19Show fewer
  • Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast.
  • History of psychiatric disorders, alcoholism or drug abuse, and other situations 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.
  • For participants requiring chemotherapy, the following must also be excluded:
  • anti-human immunodeficiency virus positive or diagnosed with acquired immune deficiency syndrome;
  • uncontrolled heart disease (heart failure [NYHA Class ≥ 2], unstable angina, myocardial infarction in past 1 year, supraventricular or ventricular arrhythmia requiring treatment or intervention).
  • For participants requiring immunotherapy, the following must also be excluded:
  • hepatitis B virus surface antigen positive and Hepatitis B virus DNA > 1000 copies/mL;
  • anti-hepatitis C virus positive;
  • active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators, exceptions are type I diabetes mellitus, hypothyroidism not requiring hormone replacement therapy, skin disorders not requiring systemic treatment [such as vitiligo, psoriasis or alopecia]);
  • previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
  • chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day, subjects who use inhaled or topical corticosteroids are eligible) or any other form of immunosuppressive therapy;
  • allergy to macromolecular protein preparations, or any component of PD-1 monoclonal antibody;
  • receiving live vaccine within 30 days prior to the first dose of PD-1 monoclonal antibody.

Trial locations and contacts

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

Jun Ma, Prof. contact

+86-20-87343469

majun2@mail.sysu.edu.cn

Cheng-Long Huang, Dr. contact

+86-13250238379

huangcl@sysucc.org.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Ya-Qian Han, Prof., +86-18673176667, hanyaqiancs@163.com

    Ya-Qian Han, Prof.

    Not yet recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Liang-Fang Shen, Prof., +86-13975805137, slf1688@sina.com

    Liang-Fang Shen, Prof.

    Not yet recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Zhi-Gang Liu, Prof., +86-13712645531, liuzhigang1983@smu.edu.cn

    Zhi-Gang Liu, Prof.

    Not yet recruiting

  • First People's Hospital of Foshan

    Foshan, Guangdong, 528000

    Gui-Chao Liu, Dr.

    Gui-Chao Liu, Dr.

    Not yet recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

    Jun Ma, +86-20-87343469, majun2@mail.sysu.edu.cn

    Cheng-Long Huang, Dr., +86-13250238379, huangcl@sysucc.org.cn

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, Guangdong, 518116

    Yan-Ling Wu, +86-18801299923, wuyl1202@163.com

    Yan-Ling Wu, Dr.

    Not yet recruiting

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong, 528400

    Gui-Qiong Xu, Dr., donna_shee@163.com

    Gui-Qiong Xu

    Not yet recruiting

Other trials in China

About this study

Official title: Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial

This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.

Read the detailed description

This multicenter, prospective, randomized phase 3 trial aims to evaluate a margin-expansion-based primary clinical target volume (CTVp) delineation strategy in patients with newly diagnosed non-metastatic nasopharyngeal carcinoma (NPC). The primary objective is to demonstrate non-inferiority of this CTVp approach compared with the consensus CTVp defined by the CSTRO, CACA, CSCO, HNCIG, ESTRO, and ASTRO guidelines (which incorporate both margin expansion and local stepwise extension patterns), with local relapse-free survival as the primary endpoint. Secondary objectives include comparisons of overall survival, failure-free survival, distant metastasis-free survival, locoregional relapse-free survival, and regional relapse-free survival between the two CTVp strategies, as well as assessments of radiotherapy-related complications, quality of life, and their impact on the tumor immune microenvironment, along with exploration of the underlying biological mechanisms.

Eligible patients will be prospectively enrolled from multiple centers across China and randomized in a 1:1 ratio to receive either the margin-based CTVp or the consensus guideline-based CTVp. Comprehensive treatment in both arms will follow current clinical guidelines and be stratified by tumor stage. Prognosis, toxicity, and quality-of-life outcomes will be systematically compared between the two groups.

Being tested
Comprehensive Therapy Based on Tumor Stage, IMRT with Primary Clinical Target Volume Based on Margin Expansion, IMRT with Consensus Primary Clinical Target Volume
Keywords
Radiotherapy, Target Delineation, Primary Clinical Target Volume, Margin
Medical subject headings
Margins of Excision

What participants receive

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

  • Comprehensive Therapy Based on Tumor StageProcedure or surgery

    1. T1N0: Radiotherapy Only.
    2. T1N1, T2N0-1, T3N0: Radiotherapy with or without Concurrent Chemotherapy (Cisplatin).
    3. T3N1, T4N0: Concurrent Chemoradiotherapy (Cisplatin) with or without Induction Chemotherapy (GP Regimen).
    4. T1-4N2-3, T4N1: ① Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin); ② Induction Chemoimmunotherapy (GP Regimen + PD-1 Monoclonal Antibody) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody); ③ Induction Chemotherapy (GP Regimen) + Concurrent Chemoradiotherapy (Cisplatin) + Adjuvant Immunotherapy (PD-1 Monoclonal Antibody).

  • IMRT with Primary Clinical Target Volume Based on Margin ExpansionRadiation

    1. Target delineation:
    2. CTVp_High = GTVp + 0 mm;
    3. CTVp_Mid = CTVp_High + 5 mm;
    4. CTVp_Low = CTVp_Mid + 5 mm + whole nasopharynx;
    5. CTVn_High = GTVn + 0 mm;
    6. CTVn_Mid = CTVn_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results;
    7. CTVn_Low = CTVn_Mid + 3 mm + elective drainage levels.
    8. Dose prescription:
    9. 6996 cGy/33 fx for CTVp_High and CTVn_High;
    10. 6006 cGy/33 fx for CTVp_Mid and CTVn_Mid;
    11. 5412 cGy/33 fx for CTVp_Low and CTVn_Low.

  • IMRT with Consensus Primary Clinical Target VolumeRadiation

    1. Target delineation:
    2. CTVp_High = GTVp + 0 mm;
    3. CTVp_Mid = CTVp_High + 5 mm;
    4. CTVp_Low = CTVp_Mid + 5 mm + whole nasopharynx + high-risk structures based on stepwise local extension patterns of tumor spread;
    5. CTVn_High = GTVn + 0 mm;
    6. CTVn_Mid = CTVn_High + 3-5 mm (for nodes with imaging-detected extranodal extension) or 0 mm (for nodes without imaging-detected extranodal extension) + equivocal nodes in the anticipated drainage levels, close proximity to enlarged nodes, or with suspicious PET results;
    7. CTVn_Low = CTVn_Mid + 3 mm + elective drainage levels;
    8. Dose prescription:
    9. 6996 cGy/33 fx for CTVp_High and CTVn_High;
    10. 6006 cGy/33 fx for CTVp_Mid and CTVn_Mid;
    11. 5412 cGy/33 fx for CTVp_Low and CTVn_Low.
Study groups in NCT07661771
Study groupRoleWhat they receive
Primary Clinical Target Volume Based on Margin ExpansionExperimentalDuring radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion.
Receives: Procedure: Comprehensive Therapy Based on Tumor Stage; Radiation: IMRT with Primary Clinical Target Volume Based on Margin Expansion
Consensus Primary Clinical Target Volume Based on Margin Expansion and Stepwise Extension PatternActive comparatorDuring radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion and local stepwise extension patterns according to the CSTRO, CACA, CSCO, HNCIG, ESTRO, and ASTRO guidelines and contouring atlas.
Receives: Procedure: Comprehensive Therapy Based on Tumor Stage; Radiation: IMRT with Consensus Primary Clinical Target Volume

What is being measured

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

  1. Local relapse-free survival (LRFS)

    Local relapse-free survival is estimated from randomisation to documented local relapse or death.

    Measured: 3 years

Secondary outcomes (8)

  1. Overall survival (OS)

    Overall survival is measured from the date of randomisation until death from any cause.

    Measured: 3 years

  2. Failure-free survival (FFS)

    Failure-free survival is measured from the date of randomisation until local recurrence, regional recurrence, distant failure, or death from any cause, whichever occurs first.

    Measured: 3 years

  3. Distant metastasis-free survival (DMFS)

    Distant metastasis-free survival is calculated from randomisation to documented distant metastasis or death.

    Measured: 3 years

  4. Locoregional relapse-free survival (LRFFS)

    Locoregional relapse-free survival is measured from the date of randomisation until local or regional recurrence or death.

    Measured: 3 years

  5. Regional relapse-free survival (RRFS)

    Regional relapse-free survival is defined as the time from randomisation to documented nodal relapse or death.

    Measured: 3 years

  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: Periprocedural.

  8. Quality of life (QoL): questionnaire

    Measured: Up to 5 years.

Timeline

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

  1. First posted22 Jun 2026
  2. Study start24 Jul 2026
  3. Primary completion30 Jul 2029 (estimated)
  4. Study completion30 Jul 2034 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
568 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661771
Sponsor's protocol ID
2026-FXY-200-FLK
Acronym
CTV-MARGIN-NPC
Status last verified
Jul 2026
First submitted
10 Jun 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wong KCW, Hui EP, Lo KW, Lam WKJ, Johnson D, Li L, Tao Q, Chan KCA, To KF, King AD, Ma BBY, Chan ATC. Nasopharyngeal carcinoma: an evolving paradigm. Nat Rev Clin Oncol. 2021 Nov;18(11):679-695. doi: 10.1038/s41571-021-00524-x. Epub 2021 Jun 30.

    PubMed 34194007

  • Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.

    PubMed 31178151

  • Liang YL, Liu X, Shen LF, Hu GY, Zou GR, Zhang N, Chen CB, Chen XZ, Zhu XD, Yuan YW, Yang KY, Jin F, Hu WH, Xie FY, Huang Y, Han F, Tang LL, Mao YP, Lu LX, Sun R, He YX, Zhou YY, Long GX, Tang J, Chen LS, Zong JF, Jin T, Li L, Lin J, Huang J, Gong XY, Zhou GQ, Chen L, Li WF, Chen YP, Xu C, Lin L, Huang SH, Huang SW, Wang YQ, Huang CL, Feng HX, Hou M, Chen CH, Zheng SF, Li YQ, Hong SB, Jie YS, Li H, Yun JP, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Li JB, Lin AH, Liu N, Zhang Y, Guo R, Ma J, Sun Y. Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1589-1598. doi: 10.1001/jama.2025.1132.

    PubMed 40079940

  • Liu X, Zhang Y, Yang KY, Zhang N, Jin F, Zou GR, Zhu XD, Xie FY, Liang XY, Li WF, He ZY, Chen NY, Hu WH, Wu HJ, Shi M, Zhou GQ, Mao YP, Guo R, Sun R, Huang J, Liang SQ, Wu WL, Su Z, Li L, Ai P, He YX, Zang J, Chen L, Lin L, Huang SH, Xu C, Lv JW, Li YQ, Hong SB, Jie YS, Li H, Huang SW, Liang YL, Wang YQ, Peng YL, Zhu JH, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Lin AH, Li JB, Liu N, Tang LL, Chen YP, Sun Y, Ma J. Induction-concurrent chemoradiotherapy with or without sintilimab in patients with locoregionally advanced nasopharyngeal carcinoma in China (CONTINUUM): a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2720-2731. doi: 10.1016/S0140-6736(24)00594-4. Epub 2024 May 30.

    PubMed 38824941

  • Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4.

    PubMed 12007936

  • Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.

    PubMed 19564532

  • Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.

    PubMed 22178121

  • Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27.

    PubMed 19251378

  • Lin S, Pan J, Han L, Zhang X, Liao X, Lu JJ. Nasopharyngeal carcinoma treated with reduced-volume intensity-modulated radiation therapy: report on the 3-year outcome of a prospective series. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1071-8. doi: 10.1016/j.ijrobp.2008.12.015. Epub 2009 Apr 11.

    PubMed 19362784

  • Lin S, Pan J, Han L, Guo Q, Hu C, Zong J, Zhang X, Lu JJ. Update report of nasopharyngeal carcinoma treated with reduced-volume intensity-modulated radiation therapy and hypothesis of the optimal margin. Radiother Oncol. 2014 Mar;110(3):385-9. doi: 10.1016/j.radonc.2014.01.011. Epub 2014 Feb 20.

    PubMed 24560755

  • Guo Q, Zheng Y, Lin J, Xu Y, Hu C, Zong J, Lu T, Xu H, Chen B, Liang Q, Xiao Y, Pan J, Lin S. Modified reduced-volume intensity-modulated radiation therapy in non-metastatic nasopharyngeal carcinoma: A prospective observation series. Radiother Oncol. 2021 Mar;156:251-257. doi: 10.1016/j.radonc.2020.12.035. Epub 2021 Jan 5.

    PubMed 33418007

  • Sanford NN, Lau J, Lam MB, Juliano AF, Adams JA, Goldberg SI, Lu HM, Lu YC, Liebsch NJ, Curtin HD, Chan AW. Individualization of Clinical Target Volume Delineation Based on Stepwise Spread of Nasopharyngeal Carcinoma: Outcome of More Than a Decade of Clinical Experience. Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):654-668. doi: 10.1016/j.ijrobp.2018.10.006. Epub 2018 Oct 15.

    PubMed 30712708

  • Xie DH, Wu Z, Li WZ, Cheng WQ, Tao YL, Wang L, Lv SW, Lin FF, Cui NJ, Zhao C, Ma J, Huang SM, Lu TX, Han YQ, Su Y. Individualized clinical target volume delineation and efficacy analysis in unilateral nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT): 10-year summary. J Cancer Res Clin Oncol. 2022 Aug;148(8):1931-1942. doi: 10.1007/s00432-022-03974-7. Epub 2022 Apr 29.

    PubMed 35486182

  • Lee AW, Ng WT, Pan JJ, Poh SS, Ahn YC, AlHussain H, Corry J, Grau C, Gregoire V, Harrington KJ, Hu CS, Kwong DL, Langendijk JA, Le QT, Lee NY, Lin JC, Lu TX, Mendenhall WM, O'Sullivan B, Ozyar E, Peters LJ, Rosenthal DI, Soong YL, Tao Y, Yom SS, Wee JT. International guideline for the delineation of the clinical target volumes (CTV) for nasopharyngeal carcinoma. Radiother Oncol. 2018 Jan;126(1):25-36. doi: 10.1016/j.radonc.2017.10.032. Epub 2017 Nov 15.

    PubMed 29153464

  • Guo R, Zhang WW, Lv J, Lin JY, Xu C, Li J, Wu YL, Zhang XM, Tang LL, Sun Y, Ma J. Long-term Outcomes Following Individualized Primary Tumor Clinical Target Volume Delineation Based on Stepwise Spread Patterns of Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy. Int J Radiat Oncol Biol Phys. 2025 May 1;122(1):126-139. doi: 10.1016/j.ijrobp.2024.12.006. Epub 2024 Dec 17.

    PubMed 39701547

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comprehensive Therapy Based on Tumor Stage, IMRT with Primary Clinical Target Volume Based on Margin Expansion and IMRT with Consensus Primary Clinical Target Volume in people with Non-metastatic Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 7 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 9 inclusion and 19 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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, Prof. (+86-20-87343469, 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?

Local relapse-free survival (LRFS) (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 NCT07661771, which also lists 19 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 19 Aug 2026.

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