RecruitingPhase 1Phase 2NCT05435014

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

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


Sponsor

T-ACE Medical Co., Ltd

Enrollment

90 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new chemotherapy oil preparation (T-ACE Oil) delivered directly to a liver tumor through its blood supply (a procedure called TAE or TACE — trans-arterial embolization/chemoembolization). The goal is to see if this new formulation improves outcomes in people with liver cancer. **You may be eligible if:** - You are 20 or older - You have been diagnosed with hepatocellular carcinoma (HCC, a type of liver cancer), confirmed by biopsy or imaging - Your cancer is at an early to intermediate stage (BCLC staging), with no more than 10 tumors and no tumor larger than 15 cm - Your liver function is still reasonably preserved - Your cancer is suitable for treatment through the blood vessels (TAE/TACE) **You may NOT be eligible if:** - Your liver function is too poor for the procedure - Your cancer is too advanced for TAE/TACE - You need more than one treatment session during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT-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.

DRUGLipiodol

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

View Full Details on ClinicalTrials.gov

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NCT05435014


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