招募中 NCT06252649

在KRAS p.G12C突变的转移性大肠癌初治参与者中, Sotorasib、Panitumumab和FOLFIRI与FOLFIRI ± Bevacizumab-awwb的研究

结直肠癌Phase IIIIII 期IV 期KRAS

本研究的目的是比较接受sotorasib、帕尼单抗和FOLFIRI的KRAS p.G12C突变转移性结直肠癌(mCRC)初治参与者与接受或不接受贝伐珠单抗-awwb治疗的FOLFIRI患者的无进展生存期(PFS)。

适应症:Metastatic Colorectal Cancer

入组条件

纳入标准

  • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  • Central laboratory detection of KRAS p.G12C mutation.
  • Measurable metastatic disease per RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • Adequate organ function.

排除标准

  • Active, untreated brain metastases.
  • Leptomeningeal disease
  • Previous treatment with a KRAS p.G12C inhibitor
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

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。