Second radiation may boost survival in returning throat cancer
NCT ID NCT07332247
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people whose nasopharyngeal cancer has come back after initial treatment and cannot be removed by surgery. Participants first receive a combination of chemotherapy and an immunotherapy drug (PD-1 inhibitor). Those whose tumors shrink or disappear are then randomly assigned to receive either immediate re-irradiation or to wait and only get radiation if needed later. The goal is to see if adding radiation right away improves overall survival and delays cancer progression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 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. Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery. 3. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III). 4. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy. 5. ECOG performance status 0-1. 6. Expected survival ≥ 3 months. 7. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma 8. No contraindications to immunotherapy, chemotherapy, or re-irradiation. 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. Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence 2. Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy. 3. Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors. 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
1 site. 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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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New triple therapy aims to control advanced nose cancer
- Can a common antiseptic spray stop radiation burns in cancer patients?
- Immunotherapy cocktail takes on tough throat cancer
- Low-Dose radiation plus immunotherapy shows promise for Tough-to-Treat nasopharyngeal cancer
- New combo therapy targets stubborn nasopharyngeal cancer in phase 3 trial
- Could delaying radiation be just as good for advanced nasopharyngeal cancer?