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这是一项关于结直肠癌的I 期 / II 期研究，登记的药物或干预包括Amivantamab IV；Fluorouracil；Leucovorin；Oxaliplatin；Irinotecan；Amivantamab，当前状态为招募中。登记地点显示中国大连、广州、杭州、武汉有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Amivantamab IV；Fluorouracil；Leucovorin；Oxaliplatin；Irinotecan；Amivantamab · I 期 / II 期
登记条件中文摘要
登记的基本范围为不限性别，年龄18 岁；另列出8项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出4项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- The Second Hospital To Dalian Medical University · 大连
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital · 广州
- The Second Affiliated Hospital of Zhejiang University College of Medicine · 杭州
- Hubei province tumor hospital · 武汉
公开的入选条件
- * Participant must have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum
- * Participant must have tumor previously characterized as having wild-type Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B (BRAF), and without evidence of Erb-b2 receptor
- Phase (Ph) 2 (Cohorts A, B, and C) Amivantamab monotherapy: Participant must have received at least 2 but not more than 3 prior lines of systemic therapy in the metastatic setting. Participant must have been diagnosed with left-sided colorectal cancer (CRC) (C
- Ph 1b Dose Confirmation Cohorts (Ph1b-D and Ph1b-E), Ph2 (Cohorts D and E) Amivantamab+mFOLFOX6/FOLFIRI: Participant must been diagnosed with CRC and have received no more than 1 prior line of systemic therapy in the metastatic setting. Cohort Ph1b-D/Cohort D:
- Ph2 Cohorts F Amivantamab subcutaneous (SC) + mFOLFOX6: Participants must be treatment-naive for right-sided unresectable or metastatic CRC and be eligible for treatment with mFOLFOX6 according to local regulatory approvals and SoC guidelines
- * For Phase 1 dose confirmation cohorts (Cohorts Ph1b-D and Ph1b-E): Participant must have evaluable disease. For Phase 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) Version 1.1. If only one measurable lesi
- * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- * Participant must have a tumor lesion amenable for biopsy and agree to mandatory protocol-defined screening biopsy. Biopsies are required if clinically feasible for participants in Ph1b-D, Ph1b-E, and Cohort F. For Cohort F, archival tissue is required if a f
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请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
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登记号：NCT05379595；登记信息更新于 2026-09-25。