Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC
Trial Parameters
Brief Summary
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;
Eligibility Criteria
Inclusion Criteria: * 18 years of age ≤65 years of age; * Cytological or histological diagnosis of surgically resectable squamous cell carcinoma of the head and neck with the following stages: T3-4a, N0-2, M0; * According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there was at least one radiologically measurable lesion; 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. * ECOG score 0-1; * Expected survival time \> 3 months; * Adequate organ function, subject shall meet the following laboratory indicators: 1. The absolute value of neutrophil granulocyte (ANC) ≥1.5x109/