NCT04523467

Anti-angiogenic Targeted Drugs Plus Rg3 to Improve the Efficacy of TACE for Unresectable Hepatocellular Carcinoma

A Multicentre Randomized Controlled Study of Anti-angiogenic Targeted Drugs Combined With Ginsenoside Rg3 to Improve the Efficacy of Transcatheter Arterial Chemoembolization (TACE) in the Treatment of Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with the anti-angiogenic targeted drugs and ginsenoside Rg3 versus TACE alone in patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage B/C hepatocellular carcinoma (HCC), who has normal liver function and no extrahepatic metastasis.

Detailed description

TACE is widely used in patients with unresectable HCC, which has been proved to significantly improve the survival time by the results from some randomized controlled studies and meta-analyses. However, due to the different blood supply characteristics and biological heterogeneity in HCC nodules, the therapeutic effect of TACE is limited, and which is still considered as a non-radical treatment. Furthermore, vascular embolization by TACE may result in hypoxia in tumor tissue, which will induce increased secretion of angiogenic factors such as vascular endothelial growth factor (VEGF) and tumor angiogenesis, promote proliferation of residual tumor cells, and enhance tumor invasive and metastasis. Accordingly, the effectiveness of TACE is still unsatisfying as a single treatment for HCC. Both anti-angiogenic targeted drugs and ginsenoside Rg3 have showed synergistic effect with TACE in patients with unresectable HCC. The purpose of this trial is to evaluate the efficacy and safety of the combination of anti-angiogenic targeted drugs and ginsenoside Rg3 plus TACE comparing to TACE alone in patients with unresectable HCC.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Anti-angiogenic Targeted Drugs	A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma
DRUG	Ginsenoside Rg3	An active ingredient extracted from ginseng leachate, which can restrain angiogenesis and reduce the expression of programmed cell death ligand 1 (PD-L1) on the tumor cell surface and block the binding of programmed cell death 1 (PD-1) and PD-L1
PROCEDURE	TACE	A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-08-21
• Last updated: 2020-08-21

Locations

1 site across 1 country: China