New combo therapy aims to improve survival in advanced nose cancer
NCT ID NCT07459296
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether a new drug (Becotatug vedotin) plus immunotherapy (sintilimab) and standard chemoradiation works better than current standard treatment for high-risk nasopharyngeal cancer. About 266 adults with advanced but non-spread cancer will be randomly assigned to one of two treatment groups. The main goal is to see if the new combination improves 3-year survival without cancer returning.
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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 266 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 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. Voluntarily participate in the study and sign the informed consent form in writing. 2. Aged 18-70 years, male or non-pregnant female. 3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III). 4. Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis. 5. ECOG performance status score of 0-1. 6. Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L. 7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN. 8. Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula). 9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Exclusion Criteria: 1. Aged \> 70 years or \< 18 years. 2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma. 3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I). 4. Patients who have previously received radiotherapy or systemic chemotherapy. 5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \> 1000 copies/mL or 200 IU/mL. 6. Positive for hepatitis C virus antibody (anti-HCV). 7. Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). 8. Patients who received systemic glucocorticoids (equivalent to prednisone \> 10 mg/day) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg/day, inhaled or topical glucocorticoids are eligible for enrollment. 9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix). 10. Patients with a history of interstitial lung disease. 11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future. 12. Pregnant or lactating females. 13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer. 14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab. 15. Patients with known history of HIV infection. 16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family/social factors.
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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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The First Affiliated Hospital of Guangxi Medical University
RECRUITINGNanning, Guangxi, 530021, 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?