NL-OMON54759招募中不适用
Organoids to Predict Treatment response In mCRC (OPTIC) - OPTIC
MC Utrecht0 个研究点目标入组 193 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 193
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1- Patients with histologically proven metastatic colorectal cancer who will
- •receive palliative standard of care systemic treatment, including, but not
- •limited to:
- •1.1. Capecitabine +/- Bevacizumab (CAP(-B))
- •1.2. Capecitabine + oxaliplatin +/- Bevacizumab (CAPOX(-B))
- •1.3. 5FU/LV + oxaliplatin + Bevacizumab (FOLFOX-B)
- •1.4. 5FU/LV + irinotecan + Bevacizumab (FOLFIRI-B)
- •1.5. 5FU/LV + oxaliplatin + irinotecan + bevacizumab (FOLFOXIRI-B)
- •1.6. FOLFIRI + panitumumab (FOLFIRI-P)
- •1.7. FOLFOX + panitumumab (FOLFOX-P)
- •1.8. Anti-EGFR monotherapy (cetuximab or panitumumab),
- •1.9. Irinotecan (IRI)
- •1.10. Trifluridine + tipiracil hydrochloride (TAS-102)
- •1.11. Encorafenib + cetuximab
- •1.12. Treatments outside the above mentioned standard of care regimens
- •(including immune checkpoint inhibitors for dMMR mCRC patients) can be
- •considered, but must be approved by the OPTIC P.I. prior to including patients.
- •2- Patient is included in PLCRC and has signed informed consent to be asked for
- •future studies and blood withdrawal within PLCRC. , 3- Patients need to have
- •measurable RECIST CT imaging (according to RECIST 1.1) or evaluable disease.,
- •4- Metastatic lesion(s), localized outside the bone, of which a biopsy can
- •safely be obtained as per local guidelines and which is RECIST measurable on CT
- •imaging., 5- Patients not known with contraindications for lidocaine (or its
- •derivatives)., 6- Patients age > 18 years, willing and able to comply with the
- •protocol as judged by the investigator with a signed informed consent.
排除标准
- •- Patients with additional unrelated tumors influencing treatment decision
- •making, potentially affecting size changes of metastases or competing risk for
研究者
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