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 range18 Years
SexALL
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…
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