New combo therapy offers hope for hard-to-treat nose cancer
NCT ID NCT07528183
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests a new treatment for people whose nose and throat cancer has returned and cannot be removed with surgery. The treatment combines an immunotherapy drug (PD-1 antibody) with two chemotherapy drugs, followed by targeted radiation. The goal is to see if this approach can help control the cancer and improve survival. The study will include 86 adults whose cancer shrank after initial chemo-immunotherapy.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- 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 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. primary tumour recurrent T classificationT2-T4, regional lymph nodes recurrent N classificationN0-N2, no distant metastasis (recurrent M0); overall recurrent stage II-III according to the American Joint Committee on Cancer Union for International Cancer Control 9th edition stage-classification system. 3. Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery. 4. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III). 5. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy. 6. ECOG performance status 0-1. 7. Expected survival ≥ 3 months. 8. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma 9. No contraindications to immunotherapy, chemotherapy, or re-irradiation. 10. 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 ≥ 50 mL/min Liver Function:Total bilirubin ≤ 1.5 × ULN,AST and ALT ≤ 2.5 × ULN. 11. 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. known pre-existing radiation-induced complications, including soft tissue necrosis, brain injury, neck fibrosis, or other radiation-induced complications of grade 3 or above 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 more than 1000 copies/mL or 200 IU/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
4 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, Fujian, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill to stop cancer treatment from stealing appetite?
- Can a Platinum-Free regimen beat nasopharyngeal carcinoma?
- Could a baking soda rinse tame radiation mouth sores?
- New drug duo aims to keep advanced nasopharyngeal cancer in check
- New surveillance strategy aims to catch residual cancer early in High-Risk nasopharyngeal carcinoma
- New combo strategy aims to catch and remove leftover cancer after radiation