Phase II Clinical Study on the Combination of Surufatinib and Envolizumab As Second-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
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.
• Subjects must meet all of the following criteria for enrollment:
‣ 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.)
⁃ Inability to perform salvage surgery as assessed by oral and maxillofacial surgeons or patient refusal of surgical treatment;
⁃ Patients must have at least one measurable lesion (RECIST 1.1);
⁃ ECOG performance status 0-2 score;
⁃ Expected survival ≥ 6 months;
⁃ Vital organs functioning as defined below (no blood components or cell growth factors allowed within 14 days prior to enrollment):
• Absolute neutrophil count ≥ 1.5 x 10 9/L;
• Platelets ≥ 90 × 10 9/L ;
• Hemoglobin ≥ 9 g/dL ;
• Serum albumin ≥ 3 g/dL ;
• Bilirubin ≤ 1.5 times ULN ;
• ALT and AST ≤ 2.5 times ULN ; ( ALT and AST ≤ 5 times ULN if liver metastases );
• Serum creatinine ≤ 1.5 times ULN ; 10. Female patients of childbearing potential voluntarily used highly effective contraception from screening through the designated time after the last dose of study drug (within 1 month after the last dose of Surufatinib or within 2 months after the last dose of envolizumab, whichever came later) and agreed not to donate ovum (oocytes) for reproductive purposes during this period.
∙ All female patients will be considered to be of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation). Male patients with sexual partners of childbearing potential who are willing to use condoms during sex from screening through 3 months after the last dose of study drug and should refrain from donating or freezing sperm during this period.