Could less radiation be enough? new trial for advanced throat cancer
NCT ID NCT07328841
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced nasopharyngeal cancer (a type of throat cancer) whose tumors shrank significantly after initial chemotherapy and immunotherapy. It compares a lower dose of radiation therapy to the standard dose, both given with additional chemo and immunotherapy. The goal is to see if the lower dose is just as effective at preventing cancer from coming back while causing fewer side effects. About 456 participants will be enrolled.
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 456 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2032
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. Histologically and/or cytologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO classification Type II or Type III). 2. Clinical stage: AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III). 3. After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, the efficacy is assessed as PR or CR by nasopharyngoscopy and enhanced MRI of nasopharynx + neck, with EBV DNA reduced to zero or below the lower limit of detection. 4. Age: 18-70 years old. 5. PS/ECOG score (performance status score of 0 or 1). 6. Adequate organ function: 1. Hematology: White blood cell count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100000/μL; 2. Liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 × ULN are eligible), AST and ALT ≤ 1.5 × ULN, and alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g/dL; 3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula. 4. Proteinuria: Urine protein/creatinine ratio (UPC ratio) \< 1.0. For those with UPC ratio ≤ 0.5, no further examination is required; for those with UPC ratio \> 0.5, further testing showing 24-hour urine protein \< 1000 mg is eligible. Note: The UPC ratio of random urine is an estimate of 24-hour urine protein quantification, and the two have a good correlation. The UPC ratio can be calculated using the following formulas: i. Urine protein/urine creatinine (if both protein and creatinine are in mg/dL); ii. (Urine protein) × 0.088/urine creatinine (if urine creatinine is in mmol/L). e) Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. 7. Patients have signed the informed consent form and are willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: 1. Patients whose laboratory test results within 7 days before enrollment do not meet the relevant standards. 2. Patients with efficacy evaluation of stable disease (SD) or progressive disease (PD) after 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment, or whose EBV DNA has not been reduced to zero or below the lower limit of detection. 3. Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment). 4. Patients with tumors accompanied by obvious liquefaction necrosis, which are unsuitable for radiotherapy or may lead to radioresistance. 5. Patients with tumors invading the brain parenchyma. 6. Patients with a history of severe allergic reactions to any components of other monoclonal antibodies or PD-1/PD-L1 monoclonal antibodies. 7. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures. 8. Patients with recurrence, distant metastasis, or concurrent other malignant tumors. 9. Patients with severe heart disease, pulmonary dysfunction, or cardiac/pulmonary function grade 3 or lower (including grade 3). 10. Patients with previous use of anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways. 11. Patients with comorbidities requiring long-term treatment with immunosuppressive drugs or systemic/local use of corticosteroids at immunosuppressive doses before enrollment. 12. Patients with HIV positivity; HBsAg positivity with positive HBV DNA copy number (quantitative detection ≥ 1000 cps/ml); positive screening for chronic hepatitis C (HCV antibody positivity). 13. Patients with a history of allergic reactions to the drugs used in this study (gemcitabine, docetaxel, taxanes, cisplatin). 14. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening. 15. Patients who, within 4 weeks before enrollment: have received systemic or local glucocorticoid treatment, been vaccinated with any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.), or used traditional Chinese herbal medicines with anti-tumor effects. 16. Women of childbearing age with positive pregnancy test results and lactating women. 17. Other patients deemed unsuitable for inclusion by the attending physician.
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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
12 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 Center of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, China
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Cancer Hospital of Shantou University Medical College
RECRUITINGShantou, Guangdong, China
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Central South University Cancer Hospital
RECRUITINGChangsha, Hunan, China
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Sun Yat-sen University cancer center
RECRUITINGGuangzhou, Guangdong, China
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The Fifth Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 516000, China
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The Fifth Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangdong, Zhuhai, 519000, China
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The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITINGNanning, Guangxi, 530021, China
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The Second Affiliated Hospital of Sun Yat-sen University (SYSU)
RECRUITINGGuangzhou, Guangdong, China
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Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
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Wuzhou Red Cross Hospital
RECRUITINGWuzhou, Guangxi, China
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Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, China
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Zhongshan City People's Hospital
RECRUITINGZhongshan, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood test model flag dangerous myelosuppression before it strikes?
- Experimental infusion drug tested against recurrent nasopharyngeal cancer
- DNA blood test may spot nasopharyngeal cancer earlier than current methods
- Million-Person quest to catch a silent cancer early
- Can a new drug combo shrink High-Risk throat tumors?
- Can a lower radiation dose still beat nasopharyngeal cancer?