Nasopharyngeal CarcinomaPhase 3NCT07328854
40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma
A Phase 3 study testing Cisplatin-based induction chemotherapy, Full course of PD-1 monoclonal antibody and Reduced-dose radiotherapy to CTV2 in people with Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 15 sites in China.
Trial summary
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Cisplatin-based induction chemotherapy, Full course of PD-1 monoclonal antibody and Reduced-dose radiotherapy to CTV2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 15 sitesChina
- Study dates
- 20 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are informed of the basic content of this study and sign an informed consent form;
- Age between 18 and 75 years;
- Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);
- Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);
- KPS ≥ 70;
- Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L;
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- Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR;
- Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy;
- Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times the upper limit of normal.
Who cannot join
- Patients with recurrent/metastatic nasopharyngeal carcinoma;
- Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);
- Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ;
- Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance;
- Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), severe psychiatric disorders, or other malignant tumours;
- Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies;
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- History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin);
- Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects;
- Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening;
- Other patients deemed ineligible for inclusion by the treating physician.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- 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
West China Hospital, Sichuan University
Chengdu, Sichuan
Lei Liu, 86+18980606231, liuleihx@gmail.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Sufang Qiu, 86+13609589163, sufangqiu@fjmu.edu.cn
- Recruiting
Sun Yat-sen University cancer center
Guangzhou, Guangdong
Peiyu Huang, 86+18928013516, huangpy@sysucc.org.cn
- Recruiting
the Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Bin Qi, 86+13580580985, qi_bin@gzhmu.edu.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Feng Jiang, 86+13858065192, jiangfeng@zjcc.org.cn
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui
Jin Gao, 86+15395005376, gj11667@126.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Zhiqiang Wang, 86+15887085161, wangzhiqiang@ydyy.cn
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Jiyong Qin, 86+13808757779, qinjiyongt@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Song Qu, 86+13607887386, 13607887386@163.com
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong
Kai Chen, 86+13005222990, chenkai89@126.com
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
Jinhui Liang, 86+13878480806
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong
Guiqiong Xu, 86+13528109888
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
Mingyuan Chen, +86-20-87343361, chenmy@sysucc.org.cn
About this study
Official title: 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
Read the detailed description
This study intends to enroll low-risk intermediate-stage nasopharyngeal carcinoma patients who achieve CR/PR after induction chemotherapy and whose plasma EBV-DNA level has dropped to 0 or below the lower detection limit. These patients will be randomly assigned at a 1:1 ratio to receive either reduced-dose radiotherapy (40.2Gy) or conventional-dose radiotherapy (49.2Gy) to CTV2. Both groups will receive full-course immunotherapy. The study will follow up to observe differences in survival, adverse events, and quality of life between the two groups. It is expected that, on the premise of maintaining treatment efficacy, reducing the dose to CTV2 can decrease acute and chronic toxicities caused by radiotherapy and chemotherapy, thereby improving patients' quality of life.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cisplatin-based induction chemotherapy, Full course of PD-1 monoclonal antibody, Reduced-dose radiotherapy to CTV2, Conventional-dose radiotherapy to CTV2
- Keywords
- Nasopharyngeal Carcinoma, Reduced-dose radiotherapy, Complete response, Partial response, Epstein-Barr Virus DNA, Low-risk target volume
- 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.
Cisplatin-based induction chemotherapyDrug
Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles.
(Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)
Full course of PD-1 monoclonal antibodyDrug
Tislelizumab 200 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.
Reduced-dose radiotherapy to CTV2Radiation
GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy
Conventional-dose radiotherapy to CTV2Radiation
GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy
| Study group | Role | What they receive |
|---|---|---|
| Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy | Experimental | Not described Receives: Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1 monoclonal antibody; Radiation: Reduced-dose radiotherapy to CTV2 |
| Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy | Active comparator | Not described Receives: Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1 monoclonal antibody; Radiation: Conventional-dose radiotherapy to CTV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence of ≥3 grade adverse events
According to NCI-CTCAE 5.0, the proportion of patients who experienced ≥3 grade adverse events during treatment and follow-up.
Measured: 3 years
Secondary outcomes (6)
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomization to the date of first distant metastases.
Measured: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 3 years
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 3 years
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: 3 months
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
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.
- First posted9 Jan 2026
- Study start20 Nov 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328854
- Sponsor's protocol ID
- ZDWY.BYAFZZX.046
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07328854
- Acronym / sponsor ID
- ZDWY.BYAFZZX.046
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Reduced-dose radiotherapy, Complete response, Partial response, Epstein-Barr Virus DNA, Low-risk target volume
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
Detailed description
This study intends to enroll low-risk intermediate-stage nasopharyngeal carcinoma patients who achieve CR/PR after induction chemotherapy and whose plasma EBV-DNA level has dropped to 0 or below the lower detection limit. These patients will be randomly assigned at a 1:1 ratio to receive either reduced-dose radiotherapy (40.2Gy) or conventional-dose radiotherapy (49.2Gy) to CTV2. Both groups will receive full-course immunotherapy. The study will follow up to observe differences in survival, adverse events, and quality of life between the two groups. It is expected that, on the premise of maintaining treatment efficacy, reducing the dose to CTV2 can decrease acute and chronic toxicities caused by radiotherapy and chemotherapy, thereby improving patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy | Experimental | Drug: Cisplatin-based induction chemotherapy, Drug: Full course of PD-1 monoclonal antibody, Radiation: Reduced-dose radiotherapy to CTV2 |
| Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy | Active comparator | Drug: Cisplatin-based induction chemotherapy, Drug: Full course of PD-1 monoclonal antibody, Radiation: Conventional-dose radiotherapy to CTV2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients are informed of the basic content of this study and sign an informed consent form;
- Age between 18 and 75 years;
- Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);
- Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);
- KPS ≥ 70;
Key exclusion criteria (10 listed)
- Patients with recurrent/metastatic nasopharyngeal carcinoma;
- Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);
- Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ;
- Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance;
- Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), severe psychiatric disorders, or other malignant tumours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin-based induction chemotherapyGemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.) | Drug | Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy, Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy |
| Full course of PD-1 monoclonal antibodyTislelizumab 200 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. | Drug | Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy, Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy |
| Reduced-dose radiotherapy to CTV2GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy | Radiation | Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy |
| Conventional-dose radiotherapy to CTV2GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy | Radiation | Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy |
Primary outcome
Progress-Free Survival (PFS)
Time frame: 3 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Incidence of ≥3 grade adverse events
Time frame: 3 years
According to NCI-CTCAE 5.0, the proportion of patients who experienced ≥3 grade adverse events during treatment and follow-up.
6 secondary outcomes
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 3 months
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Yuan Chen, MD,PhD principal investigator
Sun Yat-sen University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin-based induction chemotherapy, Full course of PD-1 monoclonal antibody and Reduced-dose radiotherapy to CTV2 in people with Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 15 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 10 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 15 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.