Can fewer Pre-Surgery doses of immunotherapy beat more in head and neck cancer?
NCT ID NCT07147426
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial is investigating whether giving tislelizumab (an immunotherapy drug) combined with chemotherapy for 2 cycles before surgery works as well as 4 cycles in people with locally advanced head and neck squamous cell carcinoma. The study aims to find the best balance between effectiveness and side effects. About 100 participants will be randomly assigned to receive either 2 or 4 cycles of the combination treatment before their planned surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab combined with cisplatin and nab-paclitaxel chemotherapy
- What this could lead to
- If successful, this could identify the optimal number of pre-surgery treatment cycles to maximize tumor shrinkage and organ preservation in head and neck cancer.
- What could go wrong
- This is a phase 2 trial with a relatively small sample size, so results may not be definitive. Combining immunotherapy with chemotherapy also carries risks of immune-related side effects and toxicity.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 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: * Histological or pathological diagnosis of head and neck squamous cell carcinoma; * Initially resectable stage III-IVB oral cancer/laryngeal cancer/hypopharyngeal cancer/P16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection; * Plan to perform neoadjuvant therapy; * No previous anti-tumor treatment for HNSCC; * There is at least one measurable lesion; * Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2; * The expected survival period is ≥3 months * The functions of vital organs meet the following requirements (excluding any blood components and cell growth factors used within 7 days) : i. Normal bone marrow reserve function, white blood cell (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥ 1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90 g/L; ii. Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥50 ml/min (Cockcroft-Gault formula); iii. Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≤ 2.5 times the upper limit of the normal value (ULN). * Be able to and willing to abide by the research and follow-up procedures; * Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment. * The patient voluntarily joined this clinical study, signed the informed consent form, had good compliance and was able to cooperate with the follow-up. Exclusion Criteria: * Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulation or checkpoint pathways); * There is a clear history of allergies, and there may be potential allergies or intolerances to the research drug and its similar biological agents; * Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; Or within 4 weeks before the first administration or planning to receive a live attenuated vaccine during the study period; * Other malignant tumors have occurred within the past five years (except for well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin); * Immunosuppressive drugs have been used within 14 days prior to the first use of tislelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/ day of prednisolone or equivalent physiological doses of other corticosteroids). * Advanced patients with symptoms, who have spread to internal organs and are at risk of life-threatening complications in the short term (including those with uncontrollable large amounts of exudate \[thoracic, pericardial, abdominal\], pulmonary lymphangitis and more than 30% liver involvement) * Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma has completely relieved in childhood and do not require any intervention in adulthood can be included; Asthma subjects who require bronchodilators for medical intervention cannot be included. * Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; Myocardial infarction occurred within 6 months before enrollment, New York Heart Association Class II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal active conduction system * Concurrent severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \>38.5°C during the screening period/before the first administration; * Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders; * Major surgical operations have been performed within 4 weeks prior to the first administration. Or have an open wound or fracture; * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; * There is central nervous system metastasis; * Those with a history of hereditary or acquired bleeding or coagulation disorders (the specific inclusion is determined by the researcher); * Other circumstances where the researcher determines that one is not suitable to participate in this study.
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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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Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
RECRUITINGTianjin, Tianjin Municipality, China
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