招募中 NCT07549412

Precemtabart Tocentecan ± Bevacizumab與Trifluridine/Tipiracil Plus Bevacizumab在既往治療轉移性大腸直腸癌受試者中的比較研究( PROCEADE-CRC-03 )

大腸直腸癌Phase IIIIII 期IV 期

本研究旨在解決先前曾接受伊立替康、奧沙利鉑、氟嘧啶和貝伐珠單抗治療的轉移性大腸癌(mCRC)參與者的未滿足醫療需求,與三氟化物/替匹拉西爾(FTD-TPI)加貝伐珠單抗相比,使用precemtabart tocentecan (Precem-TcT)作為單一藥物或Precem-TcT與貝伐珠單抗聯合治療可延長整體生存期。

適應症:Metastatic Colorectal Cancer

收案條件

納入條件

  • 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

排除條件

  • 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

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。