New drug combo aims to boost radiation success in EBV-related throat cancer
NCT ID NCT06592599
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving three drugs (gemcitabine, docetaxel, and toripalimab) before standard radiation can safely improve outcomes for people with a specific throat cancer caused by the Epstein-Barr virus. About 24 adults with advanced but not spread cancer will receive the drug combination, then radiation. The goal is to see if this approach helps more people complete treatment and achieve a complete response.
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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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jan 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 years and older
- 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. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8 2. Prior therapy: None for NPC permitted 3. Life expectancy: 3 months at least 4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose. 5. ECOG Performance Status of 0,1, or 2 6. Age: At least 18 years old. CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows: 7. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 8. Platelets ≥ 100,000 cells/mm3; 9. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows: 10. Total bilirubin ≤ 1.5 x institutional ULN; 11. AST and ALT ≤ 1.5 x institutional ULN; Adequate renal function within 21 days prior to day 1 of treatment, defined as follows: 12. Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min 13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential 14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: 1. Prior systemic anticancer treatment for NPC 2. Prior radiation to head and neck region or regions necessitating overlapping fields 3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational. 4. History of allergic reactions to any agents in this study 5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition. 6. Pregnant or breastfeeding 7. Severe, active co-morbidity, defined as follows: * Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy; * Unstable angina and/or uncontrolled congestive heart failure within past 6 months; * Myocardial infarction within the last 6 months; * Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment; 8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive 9. Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed 10. ≥ grade 2 peripheral sensory neuropathy
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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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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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Other studies related to the condition(s) this trial covers.
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- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
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