A Multi-Center, Randomized, Open-label, Parallel, Positive Controlled Trial for the Efficacy and Safety of Shouzu Ning Decoction in the Treatment of MKIs-induced grade II Hand-Foot Syndrome

The First Affiliated Hospital of Zhejiang Chinese Medical University0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1. Male or female patients, age > 18 years;
•2. Patients receiving MKIs for any malignancy;
•3. Grade II 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.

•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. Administration of drugs eg non-steroidal anti-inflammatory drugs and opioid analgesics, etc. confounding assessment of HFS;
•4. Uncontrolled infections and metabolic diseases;
•5. Coagulation disorders, known bleeding tendency or thrombophilia;
•6. The investigators consider the patients are not suitable for this trial.

发起方

The First Affiliated Hospital of Zhejiang Chinese Medical University