Immunotherapy cocktail shows promise against tough throat cancer
NCT ID NCT05211232
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether adding the immunotherapy drug tislelizumab to standard chemotherapy can improve outcomes for people with locoregionally advanced nasopharyngeal carcinoma. About 450 participants will receive either tislelizumab plus chemo or a placebo plus chemo before and after standard radiation. The study measures how many tumors completely disappear and how long people live without the cancer progressing.
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) combined with chemotherapy (gemcitabine and cisplatin)
- What this could lead to
- If successful, this could offer a more effective treatment option for people with advanced nasopharyngeal cancer, potentially shrinking tumors more and delaying cancer return.
- What could go wrong
- This is still a clinical trial, so results are not guaranteed. The treatment may cause side effects like immune-related reactions, and it may not work better than standard therapy.
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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450 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Jun 2028
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must be informed of the investigational nature of this study and give written informed consent. 2. Age ≥ 18 years and ≤70 years,men or non-pregnant women. 3. Patients with histologically confirmed Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III). 4. Tumor staged as III-IVA (AJCC 8th, except T3N0,T3N1(Only retropharyngeal lymph nodes metastasized). 5. No previous anti-tumor treatment. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 7. Adequate marrow function:White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L. 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value. Exclusion Criteria: 1. Patients with recurrent or metastatic nasopharyngeal carcinoma. 2. Histologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx. 3. Prior therapy with radiation or systemic chemotherapy. 4. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 5. Seropositivity for human immunodeficiency virus (HIV). 6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies. 8. Patients with immunodeficiency disease or a history of organ transplantation. 9. Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks. 10. Patients with severe dysfunction of heart, liver, lung, kidney or marrow. 11. Patients with severe, uncontrolled disease or infections. 12. Received other research drugs or in other clinical trials at the same time. 13. Refuse or fail to sign the informed consent . 14. Patients with other treatment contraindications. 15. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct. 16. Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml. 17. Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative. 18. Patients who were known to be intolerable or allergic to treatment drug.
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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.
Contacts and locations
Locations
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Guizhou Cancer Hospital
Guiyang, Guizhou, China
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Hunan Cancer Hospital
Changsha, Hunan, China
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The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
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Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test