Comparing Four vs Two Courses of Pembrolizumab with Carboplatin and Albumin-binding Paclitaxel Before Surgery in Resectable Head and Neck Squamous Cell Carcinoma T3 or T4, N0

What this Trial Is About

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma stages T3 or T4, N0. This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab 200 mg IV, carboplatin 300 mgm2 IV, and albumin-bound paclitaxel 260 mgm2 IV every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.

4 Courses vs 2 Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel of Neoadjuvant Therapy in HNSCC