Phase 2 Study of Surufatinib and Envolizumab as Second-Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Surufatinib and Envolizumab as a second-line treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma. This phase II clinical trial aims to assess the effectiveness and safety of this drug combination in patients whose disease has progressed after first-line systemic therapy. The study is sponsored by Shanghai Ninth Peoples Hospital affiliated with Shanghai Jiao Tong University. The treatment involves receiving Envolizumab 300 mg via subcutaneous injection every three weeks and taking Surufatinib orally at 200 mg once daily within one hour after breakfast on a continuous 3-week cycle. If treatment-related side effects reach grade 2 or higher, Surufatinibs dose may be reduced to 100 mg based on clinical judgment. The study includes three periods screening, treatment, and follow-up. Tumor assessments through imaging occur every six weeks during treatment until disease progression, intolerable toxicity, or death. Participants will undergo evaluations including adverse event monitoring, laboratory tests, vital signs, electrocardiograms, and cardiac ultrasounds. Tumor response is assessed using RECIST 1.1 criteria. Researchers will record treatment effects and survival status after disease progression. The primary outcome is the objective response rate at one year, with secondary outcomes including disease control rate, duration of response, progression-free survival, and overall survival. The total participation duration depends on treatment tolerance and disease status.

Surufatinib Combined with Envolizumab As Second-line Treatment for Recurrent/Metastatic HNSCC