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New risk model may let some NPC patients avoid unnecessary chemo

NCT ID NCT07590024

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a personalized approach for people with advanced nasopharyngeal cancer. After standard chemoradiation, some patients get extra therapy to prevent the cancer from returning. But this extra therapy can cause side effects. The trial uses a new risk model (RAIRI) to identify patients who are at low risk of recurrence. Those patients would skip the extra therapy and just be monitored. The goal is to see if this personalized strategy is as safe and effective as giving everyone extra therapy. About 651 participants will be enrolled across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PD-1 inhibitor or capecitabine
What this could lead to
If successful, this approach could spare low-risk nasopharyngeal cancer patients from unnecessary chemotherapy side effects while maintaining cancer control.
What could go wrong
This is a phase 3 trial, but the risk model is new and may not accurately identify all low-risk patients, potentially leading to undertreatment in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 651 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Age 18-65 years, regardless of sex. 2. Histologically confirmed EBER-positive, non-metastatic, non-keratinizing nasopharyngeal carcinoma. 3. AJCC 9th edition stage II-III disease / AJCC 8th edition stage III-IVA disease, excluding T3-T4N0 and T3N1 disease; or baseline EBV DNA \>4,000 copies/mL. 4. Eastern Cooperative Oncology Group performance status score of 0-1. 5. Availability of complete baseline pretreatment imaging data, including nasopharyngeal and neck MRI with functional MRI sequences, and at least one measurable tumor lesion. 6. Availability of pretreatment baseline plasma cfEBV-DNA measurement. 7. Patients must meet the following laboratory criteria: hemoglobin \>120 g/L and white blood cell count ≥4 × 10⁹/L. 8. Platelet count ≥100 × 10⁹/L; liver and renal function parameters within 1.25 times the upper limit of normal; and no hearing impairment. 9. Ability to understand the study and provision of written informed consent. 10. Agreement to allow the use of personal data and biological samples, including blood and tissue samples, for research purposes. 11. Adequate function of major organs, except for abnormalities related to nasopharyngeal carcinoma. 12. Ability and willingness to comply with scheduled follow-up. Exclusion Criteria 1. Absence of pretreatment cfEBV-DNA data or other essential baseline characteristic data. 2. AJCC 8th edition stage I-II or IVB disease / AJCC 9th edition stage I or IV disease, or T3-4N0 or T3N1 disease. 3. History of other malignancies, except stage I non-melanoma skin cancer or carcinoma in situ of the cervix. 4. Pregnant or lactating women, or women of childbearing potential who are not using contraception. 5. Current participation in another investigational drug trial. 6. Severe comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, active ulcer disease, psychiatric illness, uncontrolled diabetes mellitus, active autoimmune disease, ongoing systemic immunosuppressive therapy, active infection requiring systemic treatment, history of human immunodeficiency virus infection, positive hepatitis B surface antigen, hepatitis B virus DNA \>1 × 10³ copies/mL or \>200 IU/mL, or positive hepatitis C virus antibody. 7. Inability to comply with regular follow-up.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.