Can an immunotherapy boost standard treatment for a Head-and-Neck cancer?
NCT ID NCT06712888
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy and radiation can improve outcomes for people with locally advanced nasopharyngeal carcinoma, a type of head-and-neck cancer. Participants will receive either toripalimab or a placebo alongside induction chemotherapy, followed by chemoradiation. The study aims to see if the combination improves progression-free survival and overall survival, and to compare safety between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (an immunotherapy drug) combined with chemotherapy (gemcitabine and cisplatin) and radiation therapy
- What this could lead to
- If it works, this combination could slow or prevent cancer progression and improve survival for people with advanced nasopharyngeal carcinoma.
- What could go wrong
- This is an early-stage test in a specific patient group; results may not apply to all patients, and adding immunotherapy can increase 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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466 people
The number who actually took part.
- Started
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Feb 2025
- Expected to finish
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Nov 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 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. Voluntarily participates and signs an informed consent form. 2. Aged 18-70 years, male or non-pregnant female. 3. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III). 4. Staging of any T, N2-3 or T4N1 (9th AJCC/UICC staging), with no distant metastasis. 5. ECOG performance status score of 0-1. 6. Hemoglobin (HGB) ≥90 g/L, neutrocyte count≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹ /L. 7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. 8. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). 9. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Exclusion Criteria: 1. Age \> 70 years or \< 18 years. 2. Patients with recurrence or distant metastases. 3. Pathologically confirmed nasopharyngeal keratinizing squamous cell carcinoma (WHO Type I). 4. Patients who have previously undergone radiotherapy or systemic chemotherapy. 5. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1000 copies/ml or 200IU/ml. 6. Hepatitis C virus (HCV) antibody positive. 7. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 8. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients who received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroids will be allowed. 9. Has a known history of active bacillus tuberculosis within 1 year; patients with adequately treated active bacillus tuberculosis over 1 year ago will be allowed. 10. Has a known history of interstitial lung disease. 11. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. 12. Is pregnant or breastfeeding. 13. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer and papillary thyroid carcinoma. 14. Has known allergy to large molecule protein products or any compound of toripalimab. 15. Has a known history of human immunodeficiency virus infection. 16. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness, or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study or interferes with the interpretation of the results.
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Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
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Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
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Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
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First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
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Fujian Cancer Hospital
Fuzhou, Fujian, China
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Guangxi Medical University Cancer Center
Nanning, Guangxi, China
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Hunan Cancer Hospital
Changsha, Hunan, China
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Sichuan Cancer Hospital
Chengdu, Sichuan, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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The Affiliated Cancer Hosipital of Guizhou Meidical University
Guiyang, Guizhou, China
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The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?