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;
Single group
combination of Surufatinib and Envolizumab
Drugenvolizumab: 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.
ORR
objective response rate (ORR) (according to RECIST 1.1)
DCR
disease control rate
DOR
duration of response
PFS
progression-free survival
OS
overall survival
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