JPRN-jRCTs011210055进行中（未招募）2 期
A multicenter study to explore the benefit of patient-reported outcome (PRO:ePRO/paper-PRO) monitoring in the treatment of patients with advanced renal cell carcinoma with cabozantinib.
Osawa Takahiro0 个研究点目标入组 105 人开始时间: 2021年12月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- •1.Patients aged 18 years or older at the time of informed consent (regardless of gender)
- •2.Patients with clinically or histologically confirmed renal cell carcinoma who are deemed eligible for cabozantinib according to the package insert.
- •3.Patients who are receiving treatment including immune checkpoint inhibitors (Pembrolizumab,
- •ipilimumab, nivolumab, avelumab, etc.) for renal cell carcinoma.
- •4.Patients who are scheduled to start treatment with cabozantinib monotherapy for unresectable or metastatic renal cell carcinoma (treatment start dose:60mg/day)
- •5.Karnofsky Performance Status (KPS) score >= 60%
- •6.Patients capable of handling electronic devices (may require some assistance)
- •7.CT or MRI including the chest and abdomen has been assessed or is expected to be assessed within 28 days prior to initiation of cabozantinib treatment (Imaging is recommended as much as possible for both CT and MRI.)
- •8.Patients expected to survive for at least 6 months at the time of informed consent
- •9.In the opinion of the investigator or sub-investigator, the subject is capable of understanding and complying with protocol requirements.
- •10.Patients who can sign and date a written informed consent form prior to enrollment in the study
排除标准
- •1.Patients with treatment-emergent adverse events that have not resolved to baseline or Grade <= 1 according to CTCAE version 5.0. unless clinically insignificant or stable on supportive care.
- •2.Pregnant or breastfeeding women, or women who are unable to prevent pregnancy during the study and for 4 months after the last dose.
- •3.Patients unable to swallow tablets
- •4.Patients previously treated with cabozantinib
- •5.History of allergy or hypersensitivity to any of the ingredients of cabozantinib.
- •6.Current or planned participation in another clinical study or a clinical study involving an intervention.
- •7.Other patients considered ineligible for the study by the investigator or sub-investigator
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