A Randomized, Phase II Study of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma. This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection ± Cisplatin in HNSCC who are eligible for resection.
Sign the informed consent voluntarily and follow the requirements of the program;
Age ≥18 years old, ≤70 years old, gender is not limited;
Physical condition score ECOG 0 or 1;
Histopathology confirmed the diagnosis of head and neck squamous cell carcinoma, and immunohistochemistry confirmed that EGFR expression was positive (defined as weak staining of > 10% of tumor cells);
Tumors originating from nasopharyngeal, paranasal, nasal or salivary glands, thyroid or parathyroid lesions, skin, unknown primary squamous cell carcinoma or non-squamous histology (e.g., mucosal melanoma);
Peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0);
Received intravenous antibiotic therapy within 7 days prior to initial dosing;
Investigational drugs that have received other clinical trials within 4 weeks prior to initial dosing;
Lei Liu
Lead sponsor
West China Hospital
Sponsor institution