Nasopharyngeal Cancinoma (NPC)Phase 3NCT07154069
Adaptive Immunotherapy for Nasopharyngeal Carcinoma
A Phase 3 study testing Radical radiotherapy of nasopharynx and neck, Capecitabine and Concurrent chemoradiotherapy (cCRT) in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Radical radiotherapy of nasopharynx and neck, Capecitabine and Concurrent chemoradiotherapy (cCRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to Sep 2033
- 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
- 18-65 years;
- Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
- Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
- ECOG performance status: 0-1;
- Adequate bone marrow function: white blood cell count > 4 × 10⁹/L, hemoglobin > 90 g/L, platelet count > 100 × 10⁹/L;
- Normal renal and hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min;
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- Normal thyroid function, amylase, lipase, pituitary function;
- Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy;
- Patients must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
- Female participants of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, regular use of oral contraceptives as prescribed) from screening until one year after treatment.
Who cannot join
- T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
- Disease progression after induction therapy;
- Hepatitis B surface antigen (HBsAg) positive with HBV DNA >1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
- Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active tuberculosis;
- Active, known, or suspected autoimmune disease. Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
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- History of interstitial lung disease or pneumonia requiring oral or intravenous steroid treatment within the past year;
- Chronic systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible;
- Uncontrolled cardiac disease;
- Pregnant or lactating women;
- History or current diagnosis of another malignancy, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma;
- Known allergy to macromolecular protein preparations or any component of toripalimab;
- Active infection requiring systemic treatment within one week prior to enrollment;
- Administration of a live vaccine within 30 days before the first dose of toripalimab;
- History of organ transplantation;
- Contraindications to MRI examination, which would prevent the completion of required imaging;
- Any other condition deemed by the investigators to potentially compromise patient safety or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ling-Long Tang, 02087343840, tangll@sysucc.org.cn
About this study
Official title: Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
- To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.
- To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
Read the detailed description
Recent trials have demonstrated that for patients with locoregionally advanced nasopharyngeal carcinoma (NPC), the addition of immnotherapy to standard induction chemotherapy followed by concurrent chemoradiotherapy significantly improves event-free survival (EFS) (NCT03700476 and NCT03427827). However, current trials on immnotherapies lack specific biomarkers for risk stratification and adaptive treatment strategies.
Epstein-Barr virus (EBV) is closely associated with the development of NPC. Cell-free EBV-DNA released by NPC cells can be detected in peripheral blood and has been strongly correlated with patient prognosis. Prospective clinical trials (NCT03855020 and NCT04907370) have confirmed that patients with undetectable EBV-DNA after induction therapy exhibit significantly better EFS compared to those with detectable post-induction EBV-DNA.
Among low-risk patients with undetectable EBV-DNA after induction therapy, the 3-year EFS rate exceeds 90%. However, the combination of immunotherapy with concurrent cisplatin-based chemoradiotherapy also leads to significant treatment-related toxicities, with 74% of patients experiencing grade 3 or higher adverse events. Therefore, there is an urgent need to explore novel treatment strategies aimed at reducing toxicity in this patient population. Recent phase 3 multicenter randomized trials have demonstrated that de-intensification strategies omitting concurrent cisplatin chemotherapy significantly reduce treatment-related toxicities in both early-stage (NCT02633202) and locoregionally advanced NPC (NCT04907370), with reductions in grade 3 or higher adverse events by 29% and 11%, respectively.
Among high-risk patients with positive EBV-DNA after induction therapy, even with the combination of immuotherapy, the 3-year EFS remains suboptimal, ranging from 65% to 80%. There is a critical need for treatment intensification strategies to improve outcomes in this group. A recently completed multicenter, randomized, phase 3 trial (NCT02958111) demonstrated that adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year following standard induction chemotherapy and concurrent chemoradiotherapy significantly improved 3-year EFS from 75.7% to 85.3% in high-risk locoregionally advanced NPC patients, with a manageable toxicity profile.
Therefore, the investigators propose the following scientific hypothesis: in low-risk patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy, radiotherapy alone can reduce the incidence of treatment-related adverse effects, without reducing survival; in high-risk patients with stable disease or detectable serum EBV-DNA, adjuvant capecitabine and immunotherapy can improve survival.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Radical radiotherapy of nasopharynx and neck, Capecitabine, Concurrent chemoradiotherapy (cCRT), Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical radiotherapy of nasopharynx and neckRadiation
Radical radiotherapy of nasopharynx and neck
CapecitabineDrug
Adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year
Concurrent chemoradiotherapy (cCRT)Drug
Concurrent chemoradiotherapy
ToripalimabDrug
Adjuvant Toripalimab (240mg day1, Q3W )
| Study group | Role | What they receive |
|---|---|---|
| Low risk arm 1 | Experimental | Radiotherapy alone Receives: Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Toripalimab |
| Low risk arm 2 | Active comparator | Concurrent chemoradiotherapy Receives: Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab |
| High risk arm 1 | Experimental | Adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy Receives: Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Capecitabine; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab |
| High risk arm 2 | Active comparator | Adjuvant immunotherapy after concurrent chemoradiotherapy Receives: Radiation: Radical radiotherapy of nasopharynx and neck; Drug: Concurrent chemoradiotherapy (cCRT); Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
The primary endpoint was event-free survival from randomisation to disease recurrence (locoregional or distant) or death from any cause in the intention-to-treat population.
Measured: 3 year
Incidence rates of vomiting as assessed by CTCAE v5.0
In the low-risk arm, the primary outcome included the incidence rates of vomiting (evaluated according to the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
Measured: 3 year
Secondary outcomes (8)
Overall survival
The secondary endpoint include overall survivall from randomisation to death from any cause in the intention-to-treat population.
Measured: 3 year
Locoregional relapse-free survival
The secondary endpoint include locoregional relapse-free survival from randomisation to local and/or regional relapse or death from any cause in the intention-to-treat population.
Measured: 3 year
Distant metastasis-free survival
The secondary endpoint include distant metastasis-free survival from randomisation to distant metastasis or death from any cause in the intention-to-treat population.
Measured: 3 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Acute and late treatment-related adverse events will be assessed by the CTCAE v 5.0(Common Terminology Criteria for Adverse Events, version 5.0).
Measured: 3 year
Number of participants with treatment-related adverse events as assessed by RTOG/EORTC System
Acute and late treatment-related adverse events will be documented according to RTOG/EORTC System.
Measured: 3 year
Patient's quality-of-life as assessed by EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3.0 questionnaires will be used to assess quality-of-life
Measured: 3 year
Patient's quality-of-life as assessed by QLQ-H&N35 v1.0
Using Quality-of-Life Head and Neck 35 items (QLQ-H\&N35) version 1.0 questionnaires
Measured: 3 year
Patient-reported tolerability as assessed by PRO-CTCAE v1.0
Tolerability was assessed from patients' subjective experience using PRO-CTCAE (version 1.0)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start13 Nov 2025
- Primary completionSep 2031 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Long Tang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154069
- Sponsor's protocol ID
- B2025-489-01
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT07154069
- Acronym / sponsor ID
- B2025-489-01
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 802 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 4 Sep 2025 (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.
- To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.
- To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
Detailed description
Recent trials have demonstrated that for patients with locoregionally advanced nasopharyngeal carcinoma (NPC), the addition of immnotherapy to standard induction chemotherapy followed by concurrent chemoradiotherapy significantly improves event-free survival (EFS) (NCT03700476 and NCT03427827). However, current trials on immnotherapies lack specific biomarkers for risk stratification and adaptive treatment strategies.
Epstein-Barr virus (EBV) is closely associated with the development of NPC. Cell-free EBV-DNA released by NPC cells can be detected in peripheral blood and has been strongly correlated with patient prognosis. Prospective clinical trials (NCT03855020 and NCT04907370) have confirmed that patients with undetectable EBV-DNA after induction therapy exhibit significantly better EFS compared to those with detectable post-induction EBV-DNA.
Among low-risk patients with undetectable EBV-DNA after induction therapy, the 3-year EFS rate exceeds 90%. However, the combination of immunotherapy with concurrent cisplatin-based chemoradiotherapy also leads to significant treatment-related toxicities, with 74% of patients experiencing grade 3 or higher adverse events. Therefore, there is an urgent need to explore novel treatment strategies aimed at reducing toxicity in this patient population. Recent phase 3 multicenter randomized trials have demonstrated that de-intensification strategies omitting concurrent cisplatin chemotherapy significantly reduce treatment-related toxicities in both early-stage (NCT02633202) and locoregionally advanced NPC (NCT04907370), with reductions in grade 3 or higher adverse events by 29% and 11%, respectively.
Among high-risk patients with positive EBV-DNA after induction therapy, even with the combination of immuotherapy, the 3-year EFS remains suboptimal, ranging from 65% to 80%. There is a critical need for treatment intensification strategies to improve outcomes in this group. A recently completed multicenter, randomized, phase 3 trial (NCT02958111) demonstrated that adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year following standard induction chemotherapy and concurrent chemoradiotherapy significantly improved 3-year EFS from 75.7% to 85.3% in high-risk locoregionally advanced NPC patients, with a manageable toxicity profile.
Therefore, the investigators propose the following scientific hypothesis: in low-risk patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy, radiotherapy alone can reduce the incidence of treatment-related adverse effects, without reducing survival; in high-risk patients with stable disease or detectable serum EBV-DNA, adjuvant capecitabine and immunotherapy can improve survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk arm 1 | Experimental | Radiation: Radical radiotherapy of nasopharynx and neck, Drug: ToripalimabRadiotherapy alone |
| Low risk arm 2 | Active comparator | Radiation: Radical radiotherapy of nasopharynx and neck, Drug: Concurrent chemoradiotherapy (cCRT), Drug: ToripalimabConcurrent chemoradiotherapy |
| High risk arm 1 | Experimental | Radiation: Radical radiotherapy of nasopharynx and neck, Drug: Capecitabine, Drug: Concurrent chemoradiotherapy (cCRT), Drug: ToripalimabAdjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy |
| High risk arm 2 | Active comparator | Radiation: Radical radiotherapy of nasopharynx and neck, Drug: Concurrent chemoradiotherapy (cCRT), Drug: ToripalimabAdjuvant immunotherapy after concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-65 years;
- Newly diagnosed, pathologically confirmed non-keratinizing carcinoma (according to WHO criteria);
- Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) as defined by the 9th edition of the American Joint Committee on Cancer (AJCC) staging system;
- ECOG performance status: 0-1;
- Adequate bone marrow function: white blood cell count > 4 × 10⁹/L, hemoglobin > 90 g/L, platelet count > 100 × 10⁹/L;
Key exclusion criteria (17 listed)
- T3N0-1, according to the American Joint Committee on Cancer (AJCC) Staging System, 9th Edition;
- Disease progression after induction therapy;
- Hepatitis B surface antigen (HBsAg) positive with HBV DNA >1×10³ copies/mL, or anti-hepatitis C virus (HCV) antibody positive;
- Anti-HIV antibody positive or diagnosed with acquired immunodeficiency syndrome (AIDS);
- Active tuberculosis;
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 |
|---|---|---|
| Radical radiotherapy of nasopharynx and neckRadical radiotherapy of nasopharynx and neck | Radiation | High risk arm 1, High risk arm 2, Low risk arm 1, Low risk arm 2 |
| CapecitabineAdjuvant metronomic capecitabine (650 mg/m² twice daily) for one year | Drug | High risk arm 1 |
| Concurrent chemoradiotherapy (cCRT)Concurrent chemoradiotherapy | Drug | High risk arm 1, High risk arm 2, Low risk arm 2 |
| ToripalimabAdjuvant Toripalimab (240mg day1, Q3W ) | Drug | High risk arm 1, High risk arm 2, Low risk arm 1, Low risk arm 2 |
Primary outcome
Event-free survival
Time frame: 3 year
The primary endpoint was event-free survival from randomisation to disease recurrence (locoregional or distant) or death from any cause in the intention-to-treat population.
Incidence rates of vomiting as assessed by CTCAE v5.0
Time frame: 3 year
In the low-risk arm, the primary outcome included the incidence rates of vomiting (evaluated according to the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
8 secondary outcomes
Overall survival
Time frame: 3 year
Locoregional relapse-free survival
Time frame: 3 year
Distant metastasis-free survival
Time frame: 3 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 year
Number of participants with treatment-related adverse events as assessed by RTOG/EORTC System
Time frame: 3 year
Patient's quality-of-life as assessed by EORTC QLQ-C30
Time frame: 3 year
Patient's quality-of-life as assessed by QLQ-H&N35 v1.0
Time frame: 3 year
Patient-reported tolerability as assessed by PRO-CTCAE v1.0
Time frame: 3 year
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radical radiotherapy of nasopharynx and neck, Capecitabine and Concurrent chemoradiotherapy (cCRT) in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site 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 10 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ling-Long Tang (02087343840, tangll@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 3 year). 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 25 Nov 2025.