Neoadjuvant Therapy With Toripalimab Combined With Cetuximab and Platinum for Resectable Locally Advanced Hypopharyngeal Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer. Participants will receive three cycles of TPC neoadjuvant therapy (toripalimab+ cetuximab + platinum), radical surgery (laryngeal preservation surgery if possible), and sequential (chemo)radiotherapy treatment after surgery. This trial aims to answer the following questions: 1. pCR rate 2. MPR rate, ORR, LPR/DFS/OS rare at 1 and 2 years 3. Safety and quality of life
• Pathologically confirmed as hypopharyngeal squamous cell carcinoma;
• Age between 18-75 years;
• Patients with resectable locally advanced hypopharyngeal cancer with T3-4aN0-3bM0 (AJCC 8th) require total laryngectomy;
• Have at least one evaluable target lesion according to RECIST 1.1 criteria.
• No previous treatment for hypopharyngeal carcinoma;
• Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
• Estimated survival ≥ 6 months;
• Normal organ function;
• HBV DNA \< 500 IU/mL (or 2500 copies/mL) and HCV RNA negative;
• Signed informed consent;
• Patients who are compliant, willing, and able to follow visiting schedules, treatment plans, laboratory tests, and other research procedures.
• Male and no pregnant female; able to use the contraceptive method during treatment.