A Prospective, Open, Single-Arm, Multi-Center Clinical Study on the Efficacy and Safety of Pi-Yan-Ning Decoction in the Treatment of Grade III Skin Rash Induced by Anti-Tumor Targeted Drugs

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 aged >18 years;
•2. Patients receiving anti-tumor targeted drugs;
•3. Grade III rash 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 (>= 75 *10^9/L), Hb (>= 80 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. Skin lesions or skin diseases considered to affect the study, or history of allergic contact with other drugs;
•2. Received hormones or antibiotics or any other drugs that may affect the skin rash within 1 week before the start of our research, including Chinese patent medicine and herbal medicine;
•3. Serious or uncontrollable systemic diseases (such as unstable respiration, circulation, digestion, urinary and blood system diseases, ect.);
•4. Previous history of neurological or mental disorders, including epilepsy and dementia;
•5. Pregnancy or lactation;
•6. The subject was considered not be able to complete the study or comply with the requirements of this study (due to management or other reasons).

发起方

The First Affiliated Hospital of Zhejiang Chinese Medical University