AzTrials
AzTrials

Hepatocellular CarcinomaPhase 1/2NCT05435014

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

A Phase 1/2 study testing T-ACE Oil and Lipiodol in people with Hepatocellular Carcinoma, run by T-ACE Medical Co., Ltd at 4 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
T-ACE Oil and Lipiodol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesTaiwan
Study dates
13 Sep 2022to 15 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Diagnosed via tumor biopsy by pathologists and confirmed by on-service physician. B. High risk patients (viral hepatitis B or C or cirrhotic) with typical liver cancer image appeared on MRI or CT scan.
  • 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.
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  • 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.
  • Willing to sign a written informed consent form.

Who cannot join

  • Major branch of portal vein has been invaded by HCC, or the patient has extrahepatic metastasis or other current malignant tumors.
  • Eligible for curative surgery or transplant as judged by PI.
  • Evidences of decompensation (Meet at least ONE of the following criteria):
  • Total Bilirubin > 2 mg/dL
  • INR > 1.7
  • Child-Pugh score >8
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  • refractory ascites
  • active bleeding
  • hepatic encephalopathy
  • severe infection
  • Any of the following findings (but not limit to):
  • Heart failure (NYHA Class III or IV), COPD (Stage III or IV)
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >500 milliseconds (ms) (CTCAE grade 3) using Fridericia's QT correction formula.
  • A history of risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval (e.g., class Ia, Ic or III antiarrhythmic drugs, tricyclic antidepressants or phenothiazines)
  • Bronchial asthma that may increase the risk associated with study participation, or may interfere with compliance of the protocol as judged by the PI.
  • Renal dysfunction (eGFR < 30 ml/min/1.73m2 and/or creatinine > 2.0x ULN), or patients who do not accept suitable hemodialysis therapy or who are planned to accept any renal replacement therapy during treatment visits. (Note: Patients receiving appropriate hemodialysis therapy may be considered for recruitment at the discretion of PI.)
  • Diagnosed with hyperthyroidism or receiving treatment for hyperthyroidism. Has unstable thyroid function as judged by the PI (e.g. TSH > 5.0 mIU/L).
  • Traumatic injuries, clinically significant hemorrhage/bleeding, or clinically significant gastrointestinal bleeding within 8 weeks.
  • Major cardiovascular disease, including stroke and transient ischemic attack (TIA).
  • Known homocystinuria.
  • Any of the following laboratory findings:
  • Absolute Neutrophil Count < 1000/μL
  • Platelets < 50,000/μL
  • Hgb < 8.5 g/dL
  • AST > 5x ULN
  • ALT > 5x ULN
  • Performance status Eastern Cooperative Oncology Group (ECOG) of 2 or more.
  • Patients whose blood vessel are too difficult to perform TACE procedure as judged by PI.
  • TACE procedure would be performed in areas of the liver where bile ducts are dilated as judged by PI.
  • Prominent Hepatic arteriovenous (AV) shunt, as judged by PI.
  • Non-targeted area may be endangered during TACE procedure, as judged by PI.
  • Patients, who have ever accepted TACE therapy, and cannot gain extra benefits from further embolization treatment.
  • Allergy or contraindication to iodine, Lipiodol®, allowed contrast agents, allowed Gelfoam suppositories or allowed artery hemostats.
  • Pregnant females or lactating females.
  • Male or female subjects with fertility who are unwilling to perform highly effective contraception method.
  • Subjects who, in the opinion of the investigator, are not suitable to participate in the trial for whatever reason.

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Tungs' Taichung Metroharbor Hospital

    Taichung, 435

  • National Cheng Kung University Hospital

    Tainan, 701

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

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

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.

Read the detailed description

Subjects with HCC that meet all eligibility criteria will be admitted to hospital, and TAE or TACE treatment are performed during the hospitalization period; after embolization, subjects are observed in the ward for 1 to 7 days, and evaluated by physician before being discharged. Subjects will be followed up for 7 weeks after treatment for safety and efficacy evaluation.

Phase I part:

12 evaluable subjects will be enrolled sequentially in Phase I part. The first 3 subjects will receive TAE treatment (whether or not they are contraindicated to Doxorubicin) and the following 3 subjects (4th to 6th subjects) will receive TACE treatment. The remaining subjects may receive TAE or TACE treatment. Subjects will be enrolled sequentially in Phase I. For the first six subjects in Phase I, after the subject completes TAE or TACE treatment and is followed for 2 weeks, safety and tolerability data during this period will be reviewed by the safety review committee (SRC); only approved by the SRC, the next subject may start the TAE or TACE treatment. For the 7th to 12th subjects in Phase I, after the subject completes TAE or TACE treatment and is followed until discharge from hospitalization, safety and tolerability data during this period will be reviewed by the safety review committee (SRC); only approved by the SRC, the next subject may start the TAE or TACE treatment. After data for all 12 evaluable subjects are reviewed by SRC and approval is given by the SRC, the study may proceed to Phase II part.

Phase II part:

70 evaluable subjects will be randomized in a 1:1 ratio to receive TAE/TACE treatment by T-ACE Oil or Lipiodol for safety and efficacy evaluation.

Being tested
T-ACE Oil, Lipiodol
Keywords
TAE, TACE, Hepatocellular Carcinoma, T-ACE Oil, TACE-OHEP-001
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-ACE OilDrug

    TAE/TACE treatment was performed with T-ACE Oil. The volume of T-ACE Oil injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with T-ACE Oil, the remaining volume administered will be study product only.

  • LipiodolDrug

    Also called Lipiodol®, Lipiodol Ultra Fluide®

    TAE/TACE treatment was performed with Lipiodol®. The volume of Lipiodol® injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with Lipiodol®, the remaining volume administered will be study product only.

Study groups in NCT05435014
Study groupRoleWhat they receive
T-ACE OilExperimentalTAE/TACE treatment was performed with T-ACE Oil.
Receives: Drug: T-ACE Oil
LipiodolActive comparatorTAE/TACE treatment was performed with Lipiodol.
Receives: Drug: Lipiodol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    All Adverse Events (AEs) occurring while on study must be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. Pre-existing conditions will be recorded as baseline on the "Medical History" of CRF. If the pre-existing condition does not change, it does not have to be reported as an AE on subsequent cycles. However, if it deteriorates at any time during the study, it will be recorded as an AE.

    Measured: Up to 12 weeks

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

    Pulmonary embolism and cerebral embolism will be considered adverse events of special interest (AESIs). AESIs will be analyzed as a safety endpoint.

    Measured: Up to 12 weeks after treatment

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

    Measured: 7 weeks after treatment

  4. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

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

  5. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

    Measured: immediately after the intervention (V2)

  6. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

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

  7. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  8. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  9. Phase I part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  10. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

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

  11. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  12. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

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

  13. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  14. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  15. Phase I part: Safety variables evaluation - pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  16. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

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

  17. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  18. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

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

  19. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  20. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  21. Phase I part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  22. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

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

  23. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  24. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

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

  25. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  26. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  27. Phase I part: Safety variables evaluation - Respiratory rate

    Respiratory rate (times/min) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  28. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

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

  29. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  30. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

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

  31. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  32. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  33. Phase I part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  34. Phase I part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

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

  35. Phase I part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  36. Phase I part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

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

  37. Phase I part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  38. Phase I part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  39. Phase I part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

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

  40. Phase I part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  41. Phase I part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

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

  42. Phase I part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  43. Phase I part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  44. Phase I part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

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

  45. Phase I part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  46. Phase I part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

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

  47. Phase I part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  48. Phase I part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  49. Phase I part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

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

  50. Phase I part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  51. Phase I part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

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

  52. Phase I part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  53. Phase I part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  54. Phase I part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

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

  55. Phase I part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  56. Phase I part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

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

  57. Phase I part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  58. Phase I part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  59. Phase I part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

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

  60. Phase I part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  61. Phase I part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

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

  62. Phase I part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  63. Phase I part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  64. Phase I part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

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

  65. Phase I part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  66. Phase I part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

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

  67. Phase I part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  68. Phase I part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  69. Phase I part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

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

  70. Phase I part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  71. Phase I part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

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

  72. Phase I part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  73. Phase I part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  74. Phase I part: Safety variables evaluation - Thyroid function (T3)

    T3 (ng/dL) of subjects will be measured.

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

  75. Phase I part: Safety variables evaluation - Thyroid function (T3)

    T3 (ng/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4).

  76. Phase I part: Safety variables evaluation - Thyroid function (Free T4)

    T4 (ng/dL) of subjects will be measured.

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

  77. Phase I part: Safety variables evaluation - Thyroid function (Free T4)

    T4 (ng/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4).

  78. Phase I part: Safety variables evaluation - Thyroid function (TSH)

    TSH (uIU/ml) of subjects will be measured.

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

  79. Phase I part: Safety variables evaluation - Thyroid function (TSH)

    TSH (uIU/ml) of subjects will be measured.

    Measured: 6 weeks after treatment (V4).

  80. Phase I part: Safety variables evaluation - ECG test

    Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

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

  81. Phase I part: Safety variables evaluation - ECG test

    Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

    Measured: immediately after the intervention (V2)

  82. Phase I part: Safety variables evaluation - ECG test

    Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

    Measured: 6 weeks after treatment (V4)

  83. Phase II part: T-ACE Oil or Lipiodol deposition type on CT scan after TAE/TACE treatment.

    CT or MRI image should be taken at the screening visit, after the TAE or TACE procedure and visit 4 (6 weeks after TAE or TACE procedure). No additional contrast will be administered for the CT after TAE or TACE procedure. V1 and V4 image evaluation will be performed by MRI. V2 image evaluation method will be performed by CT scan. If the subject has had an MRI examination within 28 days before TAE/TACE treatment, the V1 MRI can be skipped.

    Measured: 72 hours after treatment

  84. Phase II part: mRECIST overall response at 6 weeks after TAE/TACE treatment.

    mRECIST (modified Response Evaluation Criteria in Solid Tumors) overall response and mRECIST target lesion response will be evaluated based on the image taken at the screening visit and at visit 4 (6 weeks after TAE or TACE procedure). mRECIST overall response for each patient will be categorized: Complete response (CR), Partial response (PR), Stable disease (SD), and Progressive disease (PD). mRECIST overall response is based on target lesions and non-target lesions responses and appearance of new lesions and/or extra-hepatic disease.

    Measured: 6 weeks after treatment.

  85. Phase II part: target lesion response at 6 weeks after TAE/TACE treatment.

    target lesion response will be evaluated based on the image

    Measured: 6 weeks after treatment.

Secondary outcomes (76)

  1. Phase I part: T-ACE Oil deposition type on CT scan after TAE/TACE treatment with T-ACE Oil.

    CT or MRI image should be taken at the screening visit, after the TAE or TACE procedure and visit 4 (6 weeks after TAE or TACE procedure). No additional contrast will be administered for the CT after TAE or TACE procedure. V1 and V4 image evaluation will be performed by MRI. V2 image evaluation method will be performed by CT scan. If the subject has had an MRI examination within 28 days before TAE/TACE treatment, the V1 MRI can be skipped.

    Measured: 72 hours after treatment

  2. Phase I part: mRECIST overall response at 6 weeks after TAE/TACE treatment with T-ACE Oil.

    mRECIST (modified Response Evaluation Criteria in Solid Tumors) overall response and mRECIST target lesion response will be evaluated based on the image taken at the screening visit and at visit 4 (6 weeks after TAE or TACE procedure). mRECIST overall response for each patient will be categorized: Complete response (CR), Partial response (PR), Stable disease (SD), and Progressive disease (PD). mRECIST overall response is based on target lesions and non-target lesions responses and appearance of new lesions and/or extra-hepatic disease.

    Measured: 6 weeks after treatment.

  3. Phase I part: target lesion response at 6 weeks after TAE/TACE treatment with T-ACE Oil.

    target lesion response will be evaluated based on the image

    Measured: 6 weeks after treatment.

  4. Phase II part: Incidence of all adverse events (AEs) after TAE/TACE treatment with T-ACE Oil or Lipiodol.

    Measured: 7 weeks after treatment

  5. Phase II part: Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oil or Lipiodol.

    Measured: 7 weeks after treatment

  6. Phase II part: Incidence of all serious adverse events (SAEs) after TAE/TACE treatment with T-ACE Oil or Lipiodol.

    Measured: 7 weeks after treatment

  7. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

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

  8. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  9. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

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

  10. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  11. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  12. Phase II part: Safety variables evaluation - Blood pressures

    Blood pressures (including SBP and DBP, unit: mmHg) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  13. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

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

  14. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  15. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

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

  16. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  17. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  18. Phase II part: Safety variables evaluation - Pulse rate

    Pulse rate (beats/min) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  19. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

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

  20. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  21. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

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

  22. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  23. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  24. Phase II part: Safety variables evaluation - Body weight.

    Body weight (kilograms) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  25. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

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

  26. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  27. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

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

  28. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  29. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  30. Phase II part: Safety variables evaluation - Body temperature.

    Body temperature (oC) of subjects will be measured.

    Measured: 7 weeks after treatment (V5)

  31. Phase II part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

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

  32. Phase II part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  33. Phase II part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

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

  34. Phase II part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  35. Phase II part: Safety variables evaluation - WBC

    WBC (1000/uL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  36. Phase II part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

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

  37. Phase II part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  38. Phase II part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

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

  39. Phase II part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  40. Phase II part: Safety variables evaluation - Platelet count

    Platelet count (1000/uL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  41. Phase II part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

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

  42. Phase II part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  43. Phase II part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

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

  44. Phase II part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  45. Phase II part: Safety variables evaluation - Hb

    Hb (g/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  46. Phase II part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

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

  47. Phase II part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  48. Phase II part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

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

  49. Phase II part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  50. Phase II part: Safety variables evaluation - blood urea nitrogen test

    BUN (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  51. Phase II part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

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

  52. Phase II part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  53. Phase II part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

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

  54. Phase II part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  55. Phase II part: Safety variables evaluation - Bilirubin

    Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  56. Phase II part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

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

  57. Phase II part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  58. Phase II part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

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

  59. Phase II part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  60. Phase II part: Safety variables evaluation - Renal function

    Creatinine (mg/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  61. Phase II part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

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

  62. Phase II part: Safety variables evaluation - Liver function

    AST and ALT (U/L) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  63. Phase II part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

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

  64. Phase II part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: immediately after the intervention (V2)

  65. Phase II part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

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

  66. Phase II part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: 2 weeks after treatment (V3)

  67. Phase II part: Safety variables evaluation - Coagulation function

    Prothrombin time and APTT (seconds) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  68. Phase II part: Safety variables evaluation - Thyroid function (T3)

    T3 (ng/dL) of subjects will be measured.

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

  69. Phase II part: Safety variables evaluation - Thyroid function (T3)

    T3 (ng/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  70. Phase II part: Safety variables evaluation - Thyroid function (Free T4)

    T4 (ng/dL) of subjects will be measured.

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

  71. Phase II part: Safety variables evaluation - Thyroid function (Free T4)

    T4 (ng/dL) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  72. Phase II part: Safety variables evaluation - Thyroid function (TSH)

    TSH (uIU/ml) of subjects will be measured.

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

  73. Phase II part: Safety variables evaluation - Thyroid function (TSH)

    TSH (uIU/ml) of subjects will be measured.

    Measured: 6 weeks after treatment (V4)

  74. Phase II part: Safety variables evaluation - ECG test

    each component of Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

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

  75. Phase II part: Safety variables evaluation - ECG test

    each component of Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

    Measured: immediately after the intervention (V2)

  76. Phase II part: Safety variables evaluation - ECG test

    each component of Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

    Measured: 6 weeks after treatment (V4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start13 Sep 2022
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Why it stopped: T-ACE Medical Co., Ltd. hereby submits this formal notification to the U.S. Food and Drug Administration (FDA) to request the permanent discontinuation and withdrawal of Investigational New Drug application IND 152626.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I/II, interventional study; competitive enrollment, multi study center * Phase I part: Open label, single arm, sequential enrollment * Phase II part: Randomized, double-blind, active controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435014
Sponsor's protocol ID
TACE-OHEP-001
Status last verified
Apr 2026
First submitted
16 Nov 2021
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Miyayama S, Yamashiro M, Okuda M, Yoshie Y, Sugimori N, Igarashi S, Nakashima Y, Notsumata K, Toya D, Tanaka N, Mitsui T, Matsui O. Chemoembolization for the treatment of large hepatocellular carcinoma. J Vasc Interv Radiol. 2010 Aug;21(8):1226-34. doi: 10.1016/j.jvir.2010.04.015. Epub 2010 Jul 3.

    PubMed 20598571

  • Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.

    PubMed 20175033

  • Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.

    PubMed 26765068

  • Wang Z, Lin M, Lesage D, Chen R, Chapiro J, Gu T, Tacher V, Duran R, Geschwind JF. Three-dimensional evaluation of lipiodol retention in HCC after chemoembolization: a quantitative comparison between CBCT and MDCT. Acad Radiol. 2014 Mar;21(3):393-9. doi: 10.1016/j.acra.2013.11.006.

    PubMed 24507426

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing T-ACE Oil and Lipiodol in people with Hepatocellular Carcinoma, run by T-ACE Medical Co., Ltd at 4 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: T-ACE Medical Co., Ltd. hereby submits this formal notification to the U.S. Food and Drug Administration (FDA) to request the permanent discontinuation and withdrawal of Investigational New Drug application IND 152626.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I part: Adverse Events as Assessed by CTCAE v5.0 (time frame: Up to 12 weeks). The study lists 85 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435014, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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