This study is a prospective,open-label,single-arm clinical trial to evaluate the efficacy and safety of s Surufatinib combined with envolizumab as second-line treatment of recurrent/metastatic head and neck squamous cell carcinoma .
envolizumab: 300 mg subcutaneously every 3 weeks (Q3W); Surufatinib : 200 mg orally within 1 hour after breakfast, once daily continuously every 3 weeks as a treatment cycle until intolerable toxicity or disease progression. If any ≥ Grade 2 treatment-related adverse event occurs during treatment, the dose may be adjusted to 100 mg according to the investigator 's clinical assessment.
The study is divided into 3 period: Screening, Treatment, and Follow-up. The treatment period is a 3-week treatment cycle. During the treatment period, tumor assessment will be performed by imaging method every 6 weeks (± 7 days) until disease progression (RECIST 1.1) or death (during treatment) or intolerable toxicity. The tumor treatment and survival status after disease progression should be recorded.
Safety measures included: adverse events, laboratory tests, vital signs, and changes in electrocardiogram and cardiac ultrasound.
Have fully understood the study and voluntarily signed the informed consent form;
Age: 18-75 years (calculated from the day of informed consent, including the boundary value), both male and female;
Pathologically or histologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
Progressive or recurrent/metastatic disease following first-line systemic therapy within 6 months of completion of concurrent chemoradiation; (first-line systemic therapy includes platinum-based chemotherapy, cetuximab plus chemotherapy, immune checkpoint inhibitors alone or in combination.)
Received previous treatment with Surufatinib and envolizumab, and 6 months with other anti-angiogenic agents;
Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy;
Participated in other domestic clinical trials of drugs not approved or marketed within 4 weeks before enrollment and received the corresponding investigational drug;
Any major surgery or invasive treatment or operation (except venous catheterization, puncture drainage, etc.) within 4 weeks before enrollment;