Immunotherapy-Chemo cocktail aims to shrink head and neck tumors before treatment
NCT ID NCT05758389
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether combining the immunotherapy drug tislelizumab with chemotherapy (paclitaxel, cisplatin, 5-FU) can shrink advanced head and neck tumors before surgery or chemoradiation. About 29 adults with stage III-IVb cancer will receive the combo for three cycles. Researchers will check tumor size and look for complete remission, while monitoring side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab (PD-1 inhibitor) combined with paclitaxel, cisplatin, and 5-FU chemotherapy
- What this could lead to
- If successful, this could offer a new treatment option for locally advanced head and neck cancer, potentially improving tumor shrinkage before surgery or chemoradiation.
- What could go wrong
- This is a small, early-phase trial with only 29 participants and no comparison group, so results may not apply broadly. Side effects from immunotherapy and chemotherapy can be serious.
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 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2025
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 75 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. Age 18-75 years old; 2. Histological or cytology-confirmed head and neck tumors (including oral, oropharynx, hypopharynx, larynx) squamous cell carcinoma, etc.; 3. Have at least one radiographically measurable lesion (RECIST 1.1 criteria); 4. The clinical stage is III-IVb (P16-) or II-III (P16+); 5. There are tumor samples that can detect gene expression; 6. ECOG score 0-1 points; 7. Have not received radiotherapy and chemotherapy or other anti-tumor drugs before; 8. The following hematological indicators need to be met: (1) Neutrophil count≥ 1.5×109/L; (2) Hemoglobin≥ 10g/dL; (3) Platelet count ≥ 100×109/L 9. The following biochemical indicators need to be met: (1) Total bilirubin ≤1.5× upper limit of normal value (ULN); (2) AST and ALT \< 1.5 ×ULN; (3) Creatinine clearance ≥ 60ml/min; (4) Alkaline phosphatase ≤ 5 times ULN; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5xULN (for anticoagulation at a stable dose such as low molecular weight heparin or warfar.) LIN and INR can be screened within the expected therapeutic range of anticoagulants) 10. Subjects of childbearing age need to take appropriate protective measures (contraceptive measures) before enrollment and in trials administration or other methods of birth control); 11. Have signed informed consent; 12. Ability to follow study protocols and follow-up procedures. Exclusion Criteria: 1. Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait; 2. Previously or concurrently suffering from other malignant tumors (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as skin basal cell carcinoma, cervical carcinoma in situ, superficial bladder cancer, and thyroid papillary carcinoma, etc.); 3. There is distant metastasis; 4. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but excludes autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone; type 1 diabetes on stable doses of insulin; vitiligo or resolved childhood asthma/allergies, Patients who do not require any intervention after adulthood; 5. Known history of primary immunodeficiency (including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation); 6. Severe infection (CTC AE\>2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; baseline chest imaging examination showed active lung Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 7. The subject has severe liver and kidney dysfunction, HIV infection, HCV infection, uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) \< 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms); uncontrolled diabetes, uncontrolled Patients with high blood pressure, hypertensive crisis or hypertensive encephalopathy or other diseases considered by the researchers to be ineligible; 8. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ml, or patients with active hepatitis C virus (HCV) should be excluded; inactive hepatitis B surface Antigen carriers, treated and stable hepatitis B patients (HBV DNA\<500IU/ml), and cured hepatitis C patients can be enrolled; 9. Have a history of interstitial lung disease (excluding radiation pneumonitis that has not been treated with hormones) and non-infectious pneumonia; 10. Active tuberculosis infection was found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment; 11. Patients who have received any of the following treatments (1) Subjects who need to be given corticosteroids (\> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies and nausea, Cases of use of corticosteroids for vomiting. In the absence of active autoimmune disease, corticosteroid replacement with inhaled or topical steroids and curative doses of prednisone \>10 mg/day is permitted; (2) Have been vaccinated against tumors; those who have been vaccinated or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (3) Received major surgery or severe trauma within 4 weeks before the first use of the study drug; (4) Enrolled in another clinical study at the same time; 12. Pregnant and lactating women. Women of childbearing age must take a pregnancy test within 7 days before enrollment Negative; 13. Substance abuse, clinical or psychological or social factors that hinder informed consent or research conduct influences; 14. Those who may be allergic to the study drug; 15. Those who cannot perform radiotherapy and chemotherapy due to social or geographical factors; 16. Significant weight loss within 6 weeks before enrollment (weight loss ≥ 10%); 17. Any uncertain factors affecting the safety or compliance of the subjects; 18. Contraindications to hormone use.
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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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Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine
RECRUITINGNanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an immunotherapy plus radiation outsmart head and neck cancer?
- Cutting radiation after surgery: a new hope for head and neck cancer patients?
- Can a new drug boost radiation's power against head and neck cancer in older patients?
- Can a Dual-Pronged antibody outsmart advanced solid tumors?