Nasopharyngeal Carcinoma (NPC)NCT07618078
Real-World RAIRI-Guided Risk Stratification for Adjuvant Therapy Benefit After Chemoradiotherapy in NPC
An observational study of Nasopharyngeal Carcinoma (NPC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- PD-1 inhibitor and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Patients aged 18 to 75 years with histologically or cytologically confirmed EBER-positive, non-keratinizing, non-metastatic nasopharyngeal carcinoma who are scheduled to receive standard chemoradiotherapy with or without induction therapy in routine clinical practice. Eligible patients must have pretreatment contrast-enhanced MRI of the nasopharynx and neck, pretreatment quantitative plasma cfEBV DNA measurement, ECOG performance status of 0-1, adequate baseline organ function, and reliable follow-up conditions. After completion of chemoradiotherapy, patients may either receive adjuvant systemic therapy, mainly PD-1 inhibitor-based immunotherapy, or undergo routine surveillance according to treating physician judgment and patient preference.
Who may be able to join
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype.
- Non-metastatic nasopharyngeal carcinoma confirmed by multimodal staging, corresponding to stage I-III according to the AJCC 9th edition staging system, or stage I-IVA according to the AJCC 8th edition staging system.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Availability of complete pretreatment high-quality contrast-enhanced MRI of the nasopharynx and neck, including functional MRI sequences such as diffusion-weighted imaging, and at least one measurable tumor lesion according to RECIST version 1.1.
- Availability of pretreatment quantitative plasma cfEBV DNA measurement.
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- Adequate baseline laboratory function, defined as hemoglobin >120 g/L, white blood cell count ≥4 × 10^9/L, platelet count ≥100 ×10^9/L, and liver and renal function parameters, including ALT, AST, total bilirubin, and serum creatinine, within 1.25 times the upper limit of normal; no severe clinically significant hearing impairment.
- Ability to fully understand the nature and follow-up procedures of this observational study, and voluntary provision of written informed consent by the patient or the patient's legally authorized representative.
- Agreement to allow the research team to use the patient's clinical data, routine diagnostic imaging data, and residual biospecimens, such as peripheral blood samples and pathological slides, for scientific research analyses.
- Adequate major organ function, except for local compression or functional impairment directly attributable to nasopharyngeal carcinoma.
- Good expected compliance with follow-up and reliable communication conditions, allowing completion of long-term survival follow-up.
Who cannot join
- Absence of pretreatment plasma cfEBV DNA measurement, or missing key baseline clinical variables required for RAIRI model calculation, such as age, AJCC stage, lactate dehydrogenase level, or central liquefactive necrosis status.
- Presence of distant metastatic disease, M1.
- History of previous or concurrent malignancy, except for non-melanoma skin cancer or cervical carcinoma in situ that has been successfully treated and has remained disease-free for more than 5 years.
- Pregnant or breastfeeding women, or participants of reproductive potential who are unwilling to use effective contraception during the study observation period.
- Current participation in another interventional clinical trial involving an investigational drug or medical device.
- Severe or uncontrolled comorbidities, including myocardial infarction within the past 6 months, severe unstable arrhythmia, severe cerebrovascular accident, active gastrointestinal ulcer, uncontrolled psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, long-term systemic immunosuppressive therapy, active severe infection requiring systemic anti-infective treatment, known history of human immunodeficiency virus infection, hepatitis B surface antigen positivity with HBV DNA >1 × 10³ copies/mL or >200 IU/mL, or hepatitis C virus antibody positivity with abnormal viral load.
- Any personal, social, geographic, or psychiatric condition that, in the investigator's judgment, would make it impossible for the participant to complete regular follow-up visits and assessments.
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Junlin Yi, +86-010-87788792, yijunlin1969@163.com
About this study
Official title: A Prospective, Multicenter, Real-World Observational Study to Evaluate RAIRI-Guided Risk Stratification for Identifying Adjuvant Therapy Benefit After Standard Chemoradiotherapy in Nasopharyngeal Carcinoma
This prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Patients will receive standard treatment according to routine clinical practice. After completion of chemoradiotherapy and assessment at approximately 1 month after radiotherapy, longitudinal multimodal response data, including plasma cfEBV DNA dynamics and MRI-based tumor response, will be incorporated into the RAIRI model to estimate the predicted 5-year progression-free survival. Patients will be stratified into a RAIRI low-risk group, defined as predicted 5-year PFS ≥85%, and a RAIRI high-risk group, defined as predicted 5-year PFS <85%.
Within each RAIRI risk stratum, outcomes will be compared between patients who receive adjuvant systemic therapy, mainly PD-1 inhibitor-based adjuvant immunotherapy, and those who undergo routine surveillance without adjuvant systemic therapy. The primary endpoint is 3-year failure-free survival. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, complete response rate after chemoradiotherapy, distribution of RAIRI risk groups, adverse events, late toxicities, and longitudinal health-related quality of life.
Read the detailed description
Nasopharyngeal carcinoma is commonly treated with intensity-modulated radiotherapy combined with platinum-based chemotherapy, with or without induction therapy. However, the optimal selection of patients for adjuvant systemic therapy after definitive chemoradiotherapy remains uncertain in routine clinical practice. Some patients may have a sufficiently favorable prognosis after chemoradiotherapy and may be safely observed, whereas others may remain at high risk of recurrence or metastasis and may benefit from treatment intensification.
This study will prospectively collect real-world clinical, imaging, laboratory, treatment exposure, toxicity, and survival data from patients with non-metastatic nasopharyngeal carcinoma treated at multiple tertiary cancer centers. The RAIRI dynamic prognostic model will be applied after completion of standard chemoradiotherapy, using baseline clinical variables and longitudinal response indicators including cfEBV DNA kinetics and MRI-based tumor regression. The model will generate an individualized predicted 5-year PFS probability. Patients with predicted 5-year PFS ≥85% will be classified as RAIRI low-risk, whereas those with predicted 5-year PFS <85% will be classified as RAIRI high-risk.
Because this is an observational study, adjuvant treatment will not be assigned by the study protocol. After chemoradiotherapy, patients may either receive adjuvant systemic therapy, mainly PD-1 monoclonal antibody therapy, or undergo routine surveillance, according to treating physician judgment and patient preference. The main analysis will compare 3-year failure-free survival between adjuvant therapy and routine surveillance within each RAIRI risk group. Propensity score matching, multivariable Cox proportional hazards models, and sensitivity analyses will be used to adjust for baseline and treatment-related confounders.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- PD-1 inhibitor, Capecitabine
- Keywords
- RAIRI, EBV-DNA, Adjuvant Therapy, Risk Stratification, response-adapted
- 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 inhibitorDrug
Administered intravenously every 3 weeks for up to 12 cycles as adjuvant therapy.
CapecitabineDrug
Metronomic capecitabine administered orally at a dose of 650 mg/m2 twice daily for one year as adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Routine Surveillance Group | Patients who do not receive adjuvant systemic therapy after completion of standard chemoradiotherapy and enter routine post-treatment surveillance according to standard clinical practice. Treatment decisions are made by treating physicians and patients, not assigned by the study protocol. | |
| Adjuvant Therapy Group | Patients who receive adjuvant systemic therapy after completion of standard chemoradiotherapy in routine clinical practice, mainly PD-1 inhibitor-based adjuvant immunotherapy. The specific agent, dose, duration, treatment interruption, and discontinuation are determined by treating physicians and prospectively recorded. Receives: Drug: PD-1 inhibitor; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Failure-Free Survival (FFS)
FFS is defined as the time from enrollment to locoregional recurrence, distant metastasis, or death from any cause.
Measured: Up to 3 years
Secondary outcomes (6)
3-year Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Up to 3 years
3-year Locoregional Relapse-Free Survival (LRRFS)
LRRFS is defined as the time from enrollment to the first locoregional recurrence or death from any cause.
Measured: Up to 3 years
3-year Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from enrollment to the first distant metastasis or death from any cause.
Measured: Up to 3 years
Complete Response (CR) Rate after Chemoradiotherapy
Proportion of patients achieving a complete response after the completion of concurrent chemoradiotherapy.
Measured: 1 month after the completion of radiotherapy
Incidence of Acute and Late Toxicities and Adverse Events
Adverse events will be evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From the start of treatment up to 3 years
Longitudinal Changes in EORTC QLQ-C30 Scores
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0. All scale and single-item scores are linearly transformed to a 0 to 100 scale. For the global health status/quality-of-life scale and functional scales, higher scores indicate better global health status, quality of life, or functioning. For symptom scales and single-item symptom measures, higher scores indicate worse symptoms or greater problems.
Measured: From baseline to 36 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Sun Yat-Sen University Cancer Center, Hunan Cancer Hospital, Xiangya Hospital of Central South University, Peking University Cancer Hospital & Institute, Cancer Hospital of Guizhou Province, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Xijing Hospital
- Responsible party
- Principal investigator, Yi Junlin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Junlin Yi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618078
- Sponsor's protocol ID
- 26/007-5732
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Real-World Observational Study to Evaluate RAIRI-Guided Risk Stratification for Identifying Adjuvant Therapy Benefit After Standard Chemoradiotherapy in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07618078
- Acronym / sponsor ID
- 26/007-5732
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- RAIRI, EBV-DNA, Adjuvant Therapy, Risk Stratification, response-adapted
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Sun Yat-Sen University Cancer Center, Hunan Cancer Hospital, Xiangya Hospital of Central South University, Peking University Cancer Hospital & Institute, Cancer Hospital of Guizhou Province, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Xijing Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 Jun 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 prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Patients will receive standard treatment according to routine clinical practice. After completion of chemoradiotherapy and assessment at approximately 1 month after radiotherapy, longitudinal multimodal response data, including plasma cfEBV DNA dynamics and MRI-based tumor response, will be incorporated into the RAIRI model to estimate the predicted 5-year progression-free survival. Patients will be stratified into a RAIRI low-risk group, defined as predicted 5-year PFS ≥85%, and a RAIRI high-risk group, defined as predicted 5-year PFS <85%.
Within each RAIRI risk stratum, outcomes will be compared between patients who receive adjuvant systemic therapy, mainly PD-1 inhibitor-based adjuvant immunotherapy, and those who undergo routine surveillance without adjuvant systemic therapy. The primary endpoint is 3-year failure-free survival. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, complete response rate after chemoradiotherapy, distribution of RAIRI risk groups, adverse events, late toxicities, and longitudinal health-related quality of life.
Detailed description
Nasopharyngeal carcinoma is commonly treated with intensity-modulated radiotherapy combined with platinum-based chemotherapy, with or without induction therapy. However, the optimal selection of patients for adjuvant systemic therapy after definitive chemoradiotherapy remains uncertain in routine clinical practice. Some patients may have a sufficiently favorable prognosis after chemoradiotherapy and may be safely observed, whereas others may remain at high risk of recurrence or metastasis and may benefit from treatment intensification.
This study will prospectively collect real-world clinical, imaging, laboratory, treatment exposure, toxicity, and survival data from patients with non-metastatic nasopharyngeal carcinoma treated at multiple tertiary cancer centers. The RAIRI dynamic prognostic model will be applied after completion of standard chemoradiotherapy, using baseline clinical variables and longitudinal response indicators including cfEBV DNA kinetics and MRI-based tumor regression. The model will generate an individualized predicted 5-year PFS probability. Patients with predicted 5-year PFS ≥85% will be classified as RAIRI low-risk, whereas those with predicted 5-year PFS <85% will be classified as RAIRI high-risk.
Because this is an observational study, adjuvant treatment will not be assigned by the study protocol. After chemoradiotherapy, patients may either receive adjuvant systemic therapy, mainly PD-1 monoclonal antibody therapy, or undergo routine surveillance, according to treating physician judgment and patient preference. The main analysis will compare 3-year failure-free survival between adjuvant therapy and routine surveillance within each RAIRI risk group. Propensity score matching, multivariable Cox proportional hazards models, and sensitivity analyses will be used to adjust for baseline and treatment-related confounders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Surveillance Group | – | –Patients who do not receive adjuvant systemic therapy after completion of standard chemoradiotherapy and enter routine post-treatment surveillance according to standard clinical practice. Treatment decisions are made by treating physicians and patients, not assigned by the study protocol. |
| Adjuvant Therapy Group | – | Drug: PD-1 inhibitor, Drug: CapecitabinePatients who receive adjuvant systemic therapy after completion of standard chemoradiotherapy in routine clinical practice, mainly PD-1 inhibitor-based adjuvant immunotherapy. The specific agent, dose, duration, treatment interruption, and discontinuation are determined by treating physicians and prospectively recorded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 75 years with histologically or cytologically confirmed EBER-positive, non-keratinizing, non-metastatic nasopharyngeal carcinoma who are scheduled to receive standard chemoradiotherapy with or without induction therapy in routine clinical practice. Eligible patients must have pretreatment contrast-enhanced MRI of the nasopharynx and neck, pretreatment quantitative plasma cfEBV DNA measurement, ECOG performance status of 0-1, adequate baseline organ function, and reliable follow-up conditions. After completion of chemoradiotherapy, patients may either receive adjuvant systemic therapy, mainly PD-1 inhibitor-based immunotherapy, or undergo routine surveillance according to treating physician judgment and patient preference.
Key inclusion criteria (11 listed)
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed EBER-positive non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype.
- Non-metastatic nasopharyngeal carcinoma confirmed by multimodal staging, corresponding to stage I-III according to the AJCC 9th edition staging system, or stage I-IVA according to the AJCC 8th edition staging system.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Availability of complete pretreatment high-quality contrast-enhanced MRI of the nasopharynx and neck, including functional MRI sequences such as diffusion-weighted imaging, and at least one measurable tumor lesion according to RECIST version 1.1.
Key exclusion criteria (7 listed)
- Absence of pretreatment plasma cfEBV DNA measurement, or missing key baseline clinical variables required for RAIRI model calculation, such as age, AJCC stage, lactate dehydrogenase level, or central liquefactive necrosis status.
- Presence of distant metastatic disease, M1.
- History of previous or concurrent malignancy, except for non-melanoma skin cancer or cervical carcinoma in situ that has been successfully treated and has remained disease-free for more than 5 years.
- Pregnant or breastfeeding women, or participants of reproductive potential who are unwilling to use effective contraception during the study observation period.
- Current participation in another interventional clinical trial involving an investigational drug or medical device.
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 |
|---|---|---|
| PD-1 inhibitorAdministered intravenously every 3 weeks for up to 12 cycles as adjuvant therapy. | Drug | Adjuvant Therapy Group |
| CapecitabineMetronomic capecitabine administered orally at a dose of 650 mg/m2 twice daily for one year as adjuvant therapy. | Drug | Adjuvant Therapy Group |
Primary outcome
3-year Failure-Free Survival (FFS)
Time frame: Up to 3 years
FFS is defined as the time from enrollment to locoregional recurrence, distant metastasis, or death from any cause.
6 secondary outcomes
3-year Overall Survival (OS)
Time frame: Up to 3 years
3-year Locoregional Relapse-Free Survival (LRRFS)
Time frame: Up to 3 years
3-year Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 3 years
Complete Response (CR) Rate after Chemoradiotherapy
Time frame: 1 month after the completion of radiotherapy
Incidence of Acute and Late Toxicities and Adverse Events
Time frame: From the start of treatment up to 3 years
Longitudinal Changes in EORTC QLQ-C30 Scores
Time frame: From baseline to 36 months after enrollment
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 3 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
Junlin Yi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma (NPC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 inclusion and 7 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 3 Jun 2026. 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.
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 Yang Liu (+86 18801342502, 530669421@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Failure-Free Survival (FFS) (time frame: Up to 3 years). 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 3 Jun 2026.