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 range18 Years

SexALL

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.
✓. May have received local therapy such as TAE, TACE, radiofrequency ablation (RFA) or surgery and remain eligible for study provided the prior therapy was within the following timeframes and the subject has fully recovered from prior therapy: A. TAE/TACE: more than 8 weeks since completion of prior therapy B. RFA: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results. C. Surgery: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results.
✓. Patients able to understand, willing to accept and cooperate with all clinical trial practices.

Exclusion criteria

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)

Phase I part: Safety variables evaluation - Blood pressures

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 range18 Years

SexALL

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.
✓. May have received local therapy such as TAE, TACE, radiofrequency ablation (RFA) or surgery and remain eligible for study provided the prior therapy was within the following timeframes and the subject has fully recovered from prior therapy: A. TAE/TACE: more than 8 weeks since completion of prior therapy B. RFA: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results. C. Surgery: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results.
✓. Patients able to understand, willing to accept and cooperate with all clinical trial practices.

Exclusion criteria

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)

Phase I part: Safety variables evaluation - Blood pressures