NCT05189171已完成不适用
MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xilis, Inc.
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- MOS generation
研究概览
简要总结
The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and completing a drug screen against patient-derived MOS using standard of care drugs used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab) in ≤ 14 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
- •Male or female age 18 or older when written informed consent is obtained.
- •Study candidate is willing and able to comply with all protocol-required procedures and assessments.
- •Study candidate either
- •is scheduled for or plans to be scheduled for a biopsy of the liver OR
- •has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver.
排除标准
- •If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.).
- •Study candidate is participating (or intends to participate) in another clinical study AND either:
- •is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR
- •that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm).
- •Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.
结局指标
主要结局
MOS generation
时间窗: <14 Days from start of MOS generation
Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
终止
不适用
A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast CancerAdvanced Breast CancerNCT04655573Duke University7
招募中
不适用
The Culture of Advanced/Recurrent/Metastatic Colorectal Cancer Organoids and Drug ScreeningColorectal CancerNCT05304741Chongqing University Cancer Hospital30
已完成
不适用
Patient-Derived Organoids for Rectal CancerRectum CancerNCT04371198Duke University20
招募中
不适用
Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology PatientsDrug MonitoringNCT06545292Leiden University Medical Center360
招募中
不适用
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma Non-resectableNCT05911633Terumo Europe N.V.50