Tislelizumab Combined With Chemotherapy for Different Cycles of Neoadjuvant Therapy for Locally A… (NCT07147426) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tislelizumab Combined With Chemotherapy for Different Cycles of Neoadjuvant Therapy for Locally Advanced Resectable Squamous Cell Carcinoma of the Head and Neck (NeoTempo)
100 participantsStarted 2025-09-20
Plain-language summary
This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological Complete Response (pCR)
Timeframe: 6 months
Trial details
NCT IDNCT07147426
SponsorTianjin Medical University Cancer Institute and Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-10-20
Contact for this trial
Tianjin Medical University Cancer Institute and Hospital