OncoMatch/Clinical Trials/NCT05941338
Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC
Is NCT05941338 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tirelizumab ,+Carboplatin+albumin-bound paclitaxel for head and neck squamous cell carcinoma.
Treatment: Tirelizumab ,+Carboplatin+albumin-bound paclitaxel — In this study, 100 patients with resectable head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma) were enrolled, who were combined with tirelizumab, carboplatin and albumin-binding paclitaxel before and after surgery. Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment. At the same time, clinical information of patients, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc. were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study. Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response (MPR) rates in the experimental group. The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during the course of this study and during follow-up, the incidence of adverse events in the experimental and control groups will be compared, and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated. Secondary Purpose 1. One-year event survival rate and event-free survival (EFS) of enrolled patients were evaluated (five years); 2. Pathological complete response rate (pCR) of enrolled patients was evaluated (5 years); 3. pTR of enrolled patients was evaluated; 4. Overall survival (OS) of enrolled patients was evaluated (5 years); 5. Radiological response of enrolled patients was assessed; 6. The rate of operation delay of enrolled patients was evaluated;
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137)
Cannot have received: systemic antitumor therapy
Exception: adjuvant/neoadjuvant platinum-containing chemotherapy or radical chemoradiotherapy allowed if interval since last chemotherapy ≥ 6 months
First-line patients: have not previously received any systemic antitumor therapy for advanced/metastatic disease. Patients who had previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or had received radical chemoradiotherapy for advanced disease, if the interval between disease progression or recurrence and the end of the last chemotherapy drug treatment was at least 6 months, were allowed to be enrolled in this study.
Cannot have received: systemic Chinese patent drugs or immunomodulatory drugs (including thymosin, interferon and interleukin)
Exception: local use to control pleural effusion allowed
Systemic treatment with Chinese patent drugs or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with indications of anti-head and neck squamous cell carcinoma within 2 weeks before the first administration
Lab requirements
Blood counts
ANC ≥1.5x10^9/L (no G-CSF in last 14 days); Platelets ≥100×10^9/L (no transfusion in past 14 days); Hemoglobin ≥9g/dL (no transfusion or erythropoietin in last 14 days)
Kidney function
Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 ml/min
Liver function
Total bilirubin ≤1.5× ULN; AST and ALT ≤2.5× ULN (≤5× ULN with liver metastasis)
Cardiac function
Myocardial enzyme profile within normal range (unless not clinically significant); ECG: no significant and severely uncontrollable abnormalities in rhythm, conduction or morphology
Adequate organ function, subject shall meet the following laboratory indicators: ... see full criteria above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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