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RECRUITING
NCT05435014
PHASE1/PHASE2

T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma

Sponsor: T-ACE Medical Co., Ltd

View on ClinicalTrials.gov

Summary

The phase I/II, double-blind, randomized study will investigate the efficacy and safety of TACE/TAE treatment with T-ACE Oil in patients with unresectable hepatocellular carcinoma.

Official title: Phase I/II Randomized, Double-Blind, First-in-Human Study of T-ACE Oil by Trans-Catheter Arterial Embolization or ChemoEmbolization (TAE/TACE) in Patients With Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-09-13

Completion Date

2026-06-30

Last Updated

2024-12-20

Healthy Volunteers

No

Interventions

DRUG

T-ACE Oil

TAE/TACE treatment was performed with T-ACE Oil. The volume of T-ACE Oil injected would be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor. The maximum dose is 0.25 mL/kg/day but not over 15 mL for each treatment.

DRUG

Lipiodol

TAE/TACE treatment was performed with Lipiodol. The volume of Lipiodol injected would be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor. The maximum dose is 0.25 mL/kg/day but not over 15 mL for each treatment.

Locations (4)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Tungs' Taichung Metroharbor Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan