A Phase II Study of the Efficacy and Safety of PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in the Second-line Treatment of Recurrent or Metastatic Anaplastic Thyroid Cancer
The purpose of this study is to evaluate the efficacy and safety of PD-1 inhibitor and anlotinib combined with multimodal radiotherapy for the second-line treatment of recurrent or metastatic anaplastic thyroid cancer.
• Age 18 years or above.
• Patients with pathologically confirmed Undifferentiated thyroid carcinoma and meet the following conditions:
‣ Were diagnosed with distant metastasis;
⁃ Were intolerant to or failed first-line treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Expected life is greater than or equal to 12 weeks.
• There is at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Adequate organ and bone marrow function:
‣ Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;
⁃ ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL；
⁃ Creatinine clearance ≥ 60 ml/min;
⁃ INR≤ 1.5, APTT≤ 1.5×ULN.
• Written informed consent.