SuspendedPhase 1/2

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

Stopped: The study was suspended in Taiwan following regulatory authority decision. The overall study under U.S. IND remains active.

Taiwan82 participantsStarted 2022-09-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age of over 18 years (or according to local legal definition of majority).
. Patients diagnosed of HCC (Meet at least ONE of the following criteria):
. In very early stage to intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦ 10, largest HCC tumor size \< 7 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score\[1\] ≦ 8.
. Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
. Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
. Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound). Subjects who have experienced on Lipiodol®-based TAE or TACE treatments are fine to recruit.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I part: Adverse Events as Assessed by CTCAE v5.0

Timeframe: Up to 12 weeks

Phase I part: Adverse Events of Special Interest (AESIs)

Timeframe: Up to 12 weeks after treatment

Phase I part: Incidence of all serious adverse events (SAEs) after TAE/TACE treatment with T-ACE Oil

Timeframe: 7 weeks after treatment

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: Pre-intervention (V1)(-28 to -1 days)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: immediately after the intervention (V2)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: 2 weeks after treatment (V3)

Trial details

NCT IDNCT05435014

SponsorT-ACE Medical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age of over 18 years (or according to local legal definition of majority).
. Patients diagnosed of HCC (Meet at least ONE of the following criteria):
. In very early stage to intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦ 10, largest HCC tumor size \< 7 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score\[1\] ≦ 8.
. Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
. Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
. Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound). Subjects who have experienced on Lipiodol®-based TAE or TACE treatments are fine to recruit.

What they're measuring

Phase I part: Adverse Events as Assessed by CTCAE v5.0

Timeframe: Up to 12 weeks

Phase I part: Adverse Events of Special Interest (AESIs)

Timeframe: Up to 12 weeks after treatment

Phase I part: Incidence of all serious adverse events (SAEs) after TAE/TACE treatment with T-ACE Oil

Timeframe: 7 weeks after treatment

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: Pre-intervention (V1)(-28 to -1 days)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: immediately after the intervention (V2)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

Phase I part: Safety variables evaluation - Blood pressures

Timeframe: 2 weeks after treatment (V3)

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria