Condition: Head and Neck Cancer · Head and Neck Cancer Squamous Cell Carcinoma · Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
This description comes directly from the study's public registry record.
guopei zhu, MD · 021-23271699-5576 · antica@gmail.com
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| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06876844