Tislelizumab with chemotherapy given before surgery in 2 or 4 cycles for locally advanced, resectable head and neck squamous cell cancer
Official title: A Prospective, Randomized Controlled, Phase II Clinical Study on the Neoadjuvant Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma With Tislelizumab Combined With Chemotherapy for Different Cycles (NeoTempo)
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07147426 · Data updated 2026-11-12
This trial tests whether 2 or 4 cycles of neoadjuvant tislelizumab plus chemotherapy can be given safely and more effectively before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | October 20, 2027 |
| Study ends | October 20, 2029 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07147426 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with initially resectable stage III–IVB oral, laryngeal, hypopharyngeal cancers or stage III/p16+ oropharyngeal cancer, good performance status, and no prior anti-tumor therapy for HNSCC.
✕Probably not a fit
Patients who do not respond to neoadjuvant therapy or who experience significant safety issues may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 trial compares two neoadjuvant regimens of tislelizumab combined with chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma. Participants are randomized to receive either 2 cycles or 4 cycles before planned surgical resection, with safety and pathological response as key outcomes. Eligible patients have untreated, biopsy-confirmed disease and are suitable for R0 resection, with adequate organ function and performance status. The study takes place at Tianjin Medical University Cancer Institute and Hospital. The lead sponsor is Tianjin Medical University Cancer Institute and Hospital, with no listed collaborators.
Why it matters
Potential benefit: If successful, patients may achieve higher rates of tumor shrinkage and better chances for complete surgical removal with tolerable safety.
How similar studies have gone: Prior studies in neoadjuvant immunotherapy for head and neck cancer have shown potential benefits, but the optimal cycle number with tislelizumab is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Tianjin Medical University Cancer Institute and Hospital
- Email: wxd.1133@163.com
- Phone: +862223340123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.