Tailored radiation aims to shrink tumors, spare healthy tissue in nasopharyngeal cancer
NCT ID NCT07661771
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times
Summary
This phase 3 trial tests whether a personalized radiation plan, which expands the treatment area based on each patient's tumor margins, can control nasopharyngeal cancer as well as the standard approach. The study includes 568 adults with newly diagnosed, non-metastatic disease. Participants receive standard therapy (chemotherapy, immunotherapy, or radiation alone depending on tumor stage) but with either the individualized or standard radiation targeting. The goal is to see if the personalized method maintains local tumor control while possibly reducing complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Individualized radiation therapy (IMRT with personalized target volume)
- What this could lead to
- If successful, this approach could offer a more precise radiation treatment for nasopharyngeal cancer, potentially reducing side effects while maintaining disease control.
- What could go wrong
- This is a non-inferiority trial, meaning it aims to show the new method is not worse than the standard. There is a risk it may not be as effective, or benefits may be small.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 568 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2034
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 Years to 65 Years. 2. Eastern Cooperative Oncology Group performance status ≤1. 3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype). 4. Tumor staged as T1-4N0-3M0 (AJCC 9th). 5. 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. 6. 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. 7. For subjects requiring chemotherapy, the following are additionally required: 1. normal bone marrow function (white blood cell count \> 4 × 10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10\^9/L); 2. 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). Exclusion Criteria: 1. 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. 2. Active infection requiring systemic treatment. 3. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer. 4. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma. 5. Prior or concurrent treatment for local or regional disease other than that specified in the research plan. 6. Pregnant or lactating women (a pregnancy test is required for women of childbearing potential). 7. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast. 8. 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. 9. For participants requiring chemotherapy, the following must also be excluded: 1. anti-human immunodeficiency virus positive or diagnosed with acquired immune deficiency syndrome; 2. uncontrolled heart disease (heart failure \[NYHA Class ≥ 2\], unstable angina, myocardial infarction in past 1 year, supraventricular or ventricular arrhythmia requiring treatment or intervention). 10. For participants requiring immunotherapy, the following must also be excluded: 1. hepatitis B virus surface antigen positive and Hepatitis B virus DNA \> 1000 copies/mL; 2. anti-hepatitis C virus positive; 3. 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 \[such as vitiligo, psoriasis or alopecia\]); 4. previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy; 5. 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; 6. allergy to macromolecular protein preparations, or any component of PD-1 monoclonal antibody; 7. receiving live vaccine within 30 days prior to the first dose of PD-1 monoclonal antibody.
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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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
NOT_YET_RECRUITINGShenzhen, Guangdong, 518116, China
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Dongguan People's Hospital
NOT_YET_RECRUITINGDongguan, Guangdong, China
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First People's Hospital of Foshan
NOT_YET_RECRUITINGFoshan, Guangdong, 528000, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, China
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Sun Yat-Sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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Xiangya Hospital Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
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Zhongshan City People's Hospital
NOT_YET_RECRUITINGZhongshan, Guangdong, 528400, China
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