Could less immunotherapy be just as good for advanced nose cancer?
NCT ID NCT07373990
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial will test whether a shorter course of the immunotherapy drug tislelizumab, combined with chemotherapy and radiation, works as well as a longer course for people with advanced nasopharyngeal cancer. About 418 participants will be randomly assigned to receive either 3 or 5 cycles of tislelizumab after initial treatment. The main goal is to see if the shorter course is non-inferior in preventing cancer from returning or spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab (an immunotherapy drug)
- What this could lead to
- If successful, this could show that a shorter course of immunotherapy is just as effective as a longer one, reducing treatment burden for patients with advanced nasopharyngeal cancer.
- What could go wrong
- This is a non-inferiority trial, so the shorter course might prove slightly less effective. The study is not yet recruiting, and results will take years. Immunotherapy can cause immune-related side effects.
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 418 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
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 and ≤65 years 2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria. 3. Eastern Cooperative Oncology Group performance score of 0-1. 4. Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition). 5. Adequate marrow function: white blood cell count \> 4 × 10⁹/L hemoglobin \>90g/L and platelet count \>100×10⁹/L 6. Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN, Alkaline phosphatase ≤ 2.5 ×ULN, clearance rate ≥ 60 ml/min 7. Other laboratory and clinical criteria Normal: thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG); For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required; For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits. 8\. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements. 9\. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Exclusion Criteria: 1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody 2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS). 3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment. 4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed. 5. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month. 6. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed. 7. Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention 8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life) 9. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma. 10. Known hypersensitivity to macromolecule protein products. 11. Active infections requiring systemic treatment within 1 week prior to enrollment. 12. Administration of live vaccines within 30 days prior to the first dose of tile. 13. History of organ transplantation or hematopoietic stem cell transplantation. 14. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors. 15. Patients who have previously received immune checkpoint (CTLA-4, PD-1, PD-L1, etc.) inhibitor therapy.
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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 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.
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