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Immunotherapy cocktail shows promise against tough throat cancer

NCT ID NCT05211232

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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

  • Guizhou Cancer Hospital

    Guiyang, Guizhou, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • The Affiliated Hospital of Guangdong Medical College

    Zhanjiang, Guangdong, China

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.