Immunotherapy plus chemo shows promise against tough throat cancer
NCT ID NCT05340270
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether adding a PD-1 inhibitor (a type of immunotherapy) to standard chemotherapy before radiation can improve outcomes for people with advanced nasopharyngeal carcinoma. About 150 participants will receive either the combination or chemotherapy alone, followed by standard chemoradiation. The main goal is to see if the combination delays cancer progression or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 inhibitor (a type of immunotherapy) plus gemcitabine and cisplatin chemotherapy
- What this could lead to
- If successful, this combination could become a new standard approach to shrink advanced nasopharyngeal tumors before radiation, potentially improving long-term survival.
- What could go wrong
- This is a mid-stage trial with only 150 participants, so results may not apply to all patients. Adding immunotherapy also raises the risk of 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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150 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Mar 2029
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. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III). 2. Original clinical staged as T4NanyM0 or TanyN2-3M0 (according to AJCC 8th edition), with no evidence of distant metastasis. 3. Eastern Cooperative Oncology Group performance status ≤1. 4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L, and platelet count ≥100×10e9/L. 5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤1.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. 6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. 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 \> 65 or \< 18. 2. Receiving radiotherapy or chemotherapy or targeted therapy or immunotherapy previously. 3. Severe cerebrovascular disease/canker/psychosis. 4. 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). 5. 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 corticosteroid will be allowed. 6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed. 7. Suffering from active infection diseases and in need of treatment. 8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. 9. Pregnant or breastfeeding. 10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer and papillary thyroid carcinoma. 11. Has known allergy to large molecule protein products or any compound of PD-1 antibody. 12. Has a known history of the human immunodeficiency virus (HIV) infection. 13. 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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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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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
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