JPRN-jRCT2031220580招募中3 期
An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+Metastatic Colorectal Cancer - MOUNTAINEER-03
Fushimi Chihiro0 个研究点目标入组 40 人开始时间: 2023年1月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
- •-Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- •- If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
- •-HER2+ disease as determined by a tissue based assay performed at a central laboratory.
- •-Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing
- •-Radiographically measurable disease per RECIST v1.1 with:
- •- At least one site of disease that iss measureable and that has not been previously irradiated, or
- •- If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •-CNS Inclusion - based on contrast brain magnetic imaging, participants may have any of the following:
- •- No evidence of brain metastases
- •- Previouslly treated brain metastates which are asymptomatic
排除标准
- •-Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting
- •- May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
- •-Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- •-Previous treatment with anti-HER2 therapy
- •-Ongoing Grade 3 or higher neuropathy
- •GI perforation within 12 months of enrollment
研究者
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