NCT07180459

The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study

The Treatment of Unresectable Liver Cancer With Graded Embolization of Uniform-sized Drug-loaded Microspheres Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Xuhua Duan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.

Conditions

• Carcinoma
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	E-TACE	The 70/100μm drug-loaded microspheres were loaded with anthracyclines (30mg-50mg Idarubicin) at 2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded anthracyclines (30mg-50mg Idarubicin) with 2mL/3mLto embolize the tumor supplying arteries at different grades and diameters.
DRUG	Donafenib	400mg QD

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-10-10
• Completion: 2027-10-10
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

10 sites across 1 country: China