癌研連線CancerLink
招募中 NCT06750094

先前接受化療的KRAS/NRAS和BRAF野生型大腸癌參與者中的Amivantamab和FOLFIRI與Cetuximab/Bevacizumab和FOLFIRI的研究

大腸直腸癌肉瘤Phase IIIIII 期IV 期EGFRKRASHER2BRAFMETMSI

本研究的目的是比較參與者無病生存期（無惡化生存期）和參與者死亡的時間長度（整體生存期） ，當使用氨萬他單抗並使用5-氟尿嘧啶、亞葉酸鈣（亞葉酸）或左旋尤科沃林和鹽酸伊立替康（ FOLFIRI ）進行化療時，與給予Kirsten大鼠肉瘤病毒性癌基因/neu參與者的西妥昔單抗或貝伐珠單抗和FOLFIRI

適應症：Colorectal Neoplasms

收案條件

納入條件

  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  • Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
  • Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
  • Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
  • Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy

排除條件

  • Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  • Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
  • Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
  • Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
  • Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

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。