Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Response rate of VEGFR inhibitor-associated hand-foot skin reaction
研究概览
简要总结
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
- •HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
- •Age from 18 to 75 years.
- •Life expectancy of at least 3 months at Day 1
排除标准
- •History of allergy to B vitamins
- •Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- •Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
- •History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
- •Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception
研究组 & 干预措施
Nicotinic acid + Routine care
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
干预措施: Nicotinic acid +Routine care (Drug)
Routine care
Routinely apply urea ointment and provide best supportive care.
干预措施: Routine care (Drug)
结局指标
主要结局
Response rate of VEGFR inhibitor-associated hand-foot skin reaction
时间窗: 2 year
Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).
Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction
时间窗: 2 year
Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.
次要结局
- Dose adjustment/withdrawal ratio(2 year)
- Hand-Foot Reaction Quality of Life (HF-QoL)(2 year)