Could delaying radiation be just as good for advanced nasopharyngeal cancer?
NCT ID NCT07235319
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This phase 3 trial is testing whether giving radiation only when needed (salvage therapy) works as well as giving it right away after immunotherapy and chemotherapy in people with nasopharyngeal cancer that has spread. The goal is to see if delaying radiation can reduce side effects without hurting survival. About 260 adults with newly diagnosed metastatic disease will take part.
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 (toripalimab, tislelizumab, or camrelizumab) plus chemotherapy (cisplatin) and locoregional radiotherapy
- What this could lead to
- If successful, this could show that delaying radiotherapy until needed is as effective as immediate treatment, potentially reducing side effects for patients with metastatic nasopharyngeal cancer.
- What could go wrong
- This is a non-inferiority trial, so it may only confirm that the delayed approach is not worse, not necessarily better. The study is still recruiting and results are years away.
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 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2035
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 70 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 18-70 years, any gender. 2. Histologically confirmed differentiated non-keratinizing carcinoma or undifferentiated non-keratinizing carcinoma by tissue biopsy, with radiologically detectable metastatic lesions. Pathological confirmation of metastatic lesions is recommended but not mandatory. 3. ECOG performance status 0-1. 4. Stage IV NPC according to the 9th edition of the UICC/AJCC staging system. 5. No prior anti-tumor treatment for NPC (radiotherapy, chemotherapy, surgery, etc.). 6. Expected survival ≥ 3 months. 7. At least one measurable lesion per RECIST v1.1. 8. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy. 9. Adequate organ function within 14 days before first dose, defined as: Hematology:Hemoglobin ≥ 90 g/L,ANC ≥ 1.5 × 10⁹/L,Platelet count ≥ 100 × 10⁹/L Renal Function:Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) / eGFR ≥ 60 mL/min Liver Function:Total bilirubin ≤ 1.5 × ULN,AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases 10. INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range,aPTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range Exclusion Criteria: 1. Prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy. 2. Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors. 3. Presence of uncontrolled or symptomatic central nervous system (CNS) metastases. 4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer. 5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma/atopy. 6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms. 7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL 8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative 9. HIV infection 10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia). 11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis. 12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound. 13. Pregnant or breastfeeding women, or those planning pregnancy during the study period. 14. Known allergy or hypersensitivity to study drugs or their excipients. 15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.
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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
5 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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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, China
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Guangxi Medical University Cancer Hospital
RECRUITINGNanning, China
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Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, China
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