招募中 NCT07549412

Precemtabart Tocentecan ± Bevacizumab与Trifluridine/Tipiracil Plus Bevacizumab在既往治疗转移性结直肠癌受试者中的比较研究( PROCEADE-CRC-03 )

结直肠癌Phase IIIIII 期IV 期

本研究旨在解决先前曾接受伊立替康、奥沙利铂、氟嘧啶和贝伐珠单抗治疗的转移性大肠癌(mCRC)参与者的未满足医疗需求,与三氟化物/替匹拉西尔(FTD-TPI)加贝伐珠单抗相比,使用precemtabart tocentecan (Precem-TcT)作为单一药物或Precem-TcT与贝伐珠单抗联合治疗可延长整体生存期。

适应症:Metastatic Colorectal Cancer

入组条件

纳入标准

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations

排除标准

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
  • Participant has a history of additional malignancy within 3 years before randomization
  • Participants with known brain metastases
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
  • Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments

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。