drugset / Trial / NCT01715532

Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

NCT01715532 ↗

Phase 2 Unknown 120 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Outcome Measures: \- To compare the progression free survival(PFS) in patients with unresectable hepatocellular carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3 family. Secondary Outcome Measures: \- To compare the overall survival(OS), objective response rate(ORR), and side effects of treating HCC with TACE plus Huachansu or TACE alone. Exploratory Outcome Measures: \- To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3 family.

Timeline

Start
2012-07
Primary completion
2016-06
Completion
2016-06

Outcome

Met primary endpoint

paper PFS and OS were significantly better in the Huachansu-TACE group than in the TACE group (p=0.029 and p=0.025, respectively), PMID 37400162 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Huachansu Traditional medicine (herbal / TCM) — Oral