進行中(不再收案) NCT03690388

Cabozantinib對比安慰劑用於曾接受血管內皮生長因子受體(VEGFR)標靶治療後惡化的放射性碘難治性分化型甲狀腺癌受試者的研究

甲狀腺癌肉瘤Phase IIIBRAF

本研究旨在評估cabozantinib對比安慰劑對曾接受血管內皮生長因子受體(VEGFR)標靶治療後惡化的放射性碘難治性分化型甲狀腺癌(DTC)受試者的無惡化存活期(PFS)及客觀緩解率(ORR)的影響。

適應症:Differentiated Thyroid Cancer

收案條件

納入條件

  • 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

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。