drugset / Trial / NCT03843229

Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer

NCT03843229

RandomizedParallel-groupOpen-labelTreatment

Summary

The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.

Timeline

Start
2019-01-27
Primary completion
2020-09-01
Completion
2020-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cinobufacini Traditional medicine (herbal / TCM) 3 unknown Other
Subject Cinobufacini Traditional medicine (herbal / TCM) 20 ml Other

Indications