Randomized Controlled Phase II Study of the Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 871
- 试验地点
- 11
- 主要终点
- The incidence of all-grade HFSR
研究概览
简要总结
Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which may have a negative impact on patient quality of life (QoL). Urea-based creams may have a prophylactic effect on sorafenib-induced HFSR in HCC patients.
详细描述
Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no randomized, controlled trials to date have evaluated treatments to prevent/palliate sorafenib-associated HFSR. We therefore tested the prophylactic effects of a urea-based cream on the incidence of HFSR associated with sorafenib treatment of patients with advanced HCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert
- •The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
- •The patients must be willing and able to complete the biweekly visits for the first 3 months;
- •The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
- •The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
- •The patient's life expectancy is ≥3 months
- •The patients must provide written informed consents
排除标准
- •The patients participated in other clinical trials
- •The patients received sorafenib therapy prior to enrollment
- •The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
- •The patient's sorafenib dosage exceeds 400mg, twice daily
研究组 & 干预措施
urea-based cream
Advanced HCC throughout China were treated with 10% urea-based cream 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for up to 12 weeks
干预措施: urea-based cream (Drug)
结局指标
主要结局
The incidence of all-grade HFSR
时间窗: Starting sorafenib treatment within 12 weeks
Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib
时间窗: Starting sorafenib treatment within 12 weeks
次要结局
- The percentage of patients requiring sorafenib dose-reduction(Starting sorafenib treatment within 12 weeks)
- The percentage of patients requiring discontinuation of sorafenib therapy(starting sorafenib treatment within 12 weeks)
- The percentage of patients discontinuing treatment(starting sorafenib treatment within 12 weeks)