ITMCTR2000003455尚未招募1 期
Efficacy and Safety of Shou-Zu-Ning Decoction in the Treatment of MKIs-induced grade III Hand-Foot Syndrome: a Prospective, Open, One-arm, Multi-Center Trial
The First Affiliated Hospital of Zhejiang Chinese Medical University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Male or female patients aged > 18 years;
- •2. Patients receiving MKIs for any malignancy;
- •3. Grade III hand-foot syndrome according to NCI-CTC 5.0 standard;
- •4. KPS > 60, life expectancy >=3 months; 5. The functional level of major organs met the following criteria:
- •1) ANC (> 1.5 *10^9/L), PLT (> 80 *10^9/L), Hb (> 90 g/L);
- •2) TBIL < 1.5 ULN, ALT, AST < 2.5 ULN, with liver metastasis < 5 ULN, BUN and Cr < 1 ULN or endogenous creatinine clearance (>50 ml/min) (Cockcroft-Gault formula);
- •6. Signed informed consent.
排除标准
- •1. Pre-existing dermopathy or drug allergy;
- •2. Concomitant administration of drugs that can cause HFS eg capecitabine, docetaxel, liposomal doxorubicin, etc. in four weeks; 3. Uncontrolled infections and metabolic diseases;
- •4. Coagulation disorders, known bleeding tendency or thrombophilia;
- •5. The investigators consider the patients are not suitable for this trial.
研究者
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