进行中(不再招募) NCT03690388

Cabozantinib对比安慰剂用于曾接受血管内皮生长因子受体(VEGFR)靶向治疗后恶化的放射性碘难治性分化型甲状腺癌受试者的研究

甲状腺癌肉瘤Phase IIIBRAF

本研究旨在评估cabozantinib对比安慰剂对曾接受血管内皮生长因子受体(VEGFR)靶向治疗后恶化的放射性碘难治性分化型甲状腺癌(DTC)受试者的无进展生存期(PFS)及客观缓解率(ORR)的影响。

适应症:Differentiated Thyroid Cancer

入组条件

纳入标准

  • Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
  • Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

排除标准

  • Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization
  • Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
  • Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。