Clinical Trials List
Protocol NumberTACE-OHEP-001
NCT Number(ClinicalTrials.gov Identfier)NCT
Active
2021-01-31 - 2026-06-30
Phase I/II
Not yet recruiting1
Recruiting3
ICD-10C22.9
Malignant neoplasm of liver, not specified as primary or secondary
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
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Trial Applicant
T-TOP Clinical Research Co., Ltd.
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Sponsor
T-ACE MEDICAL Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ming-Chih Ho Division of General Surgery
- REY-HENG HU Division of General Surgery
- 蘇東弘 Digestive System Department
- 何承懋 Division of General Surgery
- 楊宏志 Division of General Internal Medicine
- JA-DER LIANG Digestive System Department
- Shih-Jer Hsu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Liu Yi-Sheng Division of Radiology
- 簡世杰 Digestive System Department
- 呂佳興 Digestive System Department
- 邱彥程 Digestive System Department
- 歐明靜 Division of Radiology
- 陳炯瑜 Digestive System Department
- 康瑞文 Digestive System Department
- 陳柏潤 Digestive System Department
- Pin-Nan Cheng Digestive System Department
- Chien-Jui Huang Digestive System Department
- Yih-Jyh Lin Division of Others -
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 孫煒智 Digestive System Department
- 王國強 Division of General Surgery
- 蔡峯偉 Digestive System Department
- 梁慧隆 Division of Radiology
- 蔡偉 Digestive System Department
- 顏家聖 Division of General Surgery
- 呂家名 Digestive System Department
- 陳文誌 Digestive System Department
- 王惠民 Digestive System Department
- 江佳陵 Division of Radiology
- 蔡騌圳 Digestive System Department
- 林恭弘 Digestive System Department
- 陳玉佳 Division of General Surgery
- 李明峰 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hepatocellular Carcinoma(HCC)
Objectives
Primary Objectives
Phase I part:
1.Evaluate the safety and tolerability of T-ACE Oil as a radiocontrast, including the side effects of the embolization, treatment-related complications and other adverse events.
Phase II part:
1.Evaluate the efficacy of the T-ACE Oil and Lipiodol as a radiocontrast, indicatingthe site of embolization.
2.Evaluate the efficacyof the T-ACE Oil and Lipiodol as an embolizer, treatingthe hepatocellular carcinoma.
Secondary Objectives
Phase I part:
1.Evaluate the potential efficacy of the T-ACE Oil as a radiocontrast, indicatingthe site of embolization.
2.Evaluate the potential efficacyof the T-ACE Oil as an embolizer, treatingthe hepatocellular carcinoma.
Phase II part:
1.Evaluate the safety and tolerability of T-ACE Oil and Lipiodolas a radiocontrast, including the side effects of the embolization, treatment-related complications and other adverse events.
Test Drug
T-ACE Oil
Active Ingredient
ethyl esters of iodized fatty acids of sunflower oil
Dosage Form
Injection
Dosage
480
Endpoints
Primary Endpoints
Phase I part:
Safety evaluations:
1.Incidence of all adverse events (AEs)after TAE/TACE treatment with T-ACE Oil
2.Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oil
3.Incidence of all serious adverse events (SAEs)after TAE/TACE treatment with T-ACE Oil
4.Safety variables evaluation: Vital signs, body weight, physical examination, clinical laboratory tests, ECG results.
Phase II part:
Efficacy evaluations:
1.Radiologicefficacy:T-ACE Oil or Lipiodol deposition type on CT scan/MRI after TAE/TACE treatment.
2.Embolization efficacy:mRECIST overall response at 6 weeks after TAE/TACE treatment.
Secondary Endpoints
Phase I part:
Potential efficacy evaluations:
1.Radiologicefficacy:T-ACE Oil deposition typeon CT scan/MRI after TAE/TACEtreatment.
2.Embolization efficacy:mRECIST overall responseat 6weeks after TAE/TACE treatment.
Phase II part:
Safety evaluations
1.Incidence of all adverse events (AEs)after TAE/TACE treatment with T-ACE Oilor Lipiodol
2.Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oilor Lipiodol
3.Incidence of all serious adverse events (SAEs)after TAE/TACE treatment with T-ACE Oilor Lipiodol
4.Safety variables evaluation: Vital signs, body weight, physical examination, clinical laboratory tests, ECG results.
Phase I part:
Safety evaluations:
1.Incidence of all adverse events (AEs)after TAE/TACE treatment with T-ACE Oil
2.Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oil
3.Incidence of all serious adverse events (SAEs)after TAE/TACE treatment with T-ACE Oil
4.Safety variables evaluation: Vital signs, body weight, physical examination, clinical laboratory tests, ECG results.
Phase II part:
Efficacy evaluations:
1.Radiologicefficacy:T-ACE Oil or Lipiodol deposition type on CT scan/MRI after TAE/TACE treatment.
2.Embolization efficacy:mRECIST overall response at 6 weeks after TAE/TACE treatment.
Secondary Endpoints
Phase I part:
Potential efficacy evaluations:
1.Radiologicefficacy:T-ACE Oil deposition typeon CT scan/MRI after TAE/TACEtreatment.
2.Embolization efficacy:mRECIST overall responseat 6weeks after TAE/TACE treatment.
Phase II part:
Safety evaluations
1.Incidence of all adverse events (AEs)after TAE/TACE treatment with T-ACE Oilor Lipiodol
2.Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oilor Lipiodol
3.Incidence of all serious adverse events (SAEs)after TAE/TACE treatment with T-ACE Oilor Lipiodol
4.Safety variables evaluation: Vital signs, body weight, physical examination, clinical laboratory tests, ECG results.
Inclution Criteria
Inclusion Criteria
1.Age of over 20 years(or according to local legal definition of majority).
2.Patients diagnosed of HCC (Meet at least ONE of the following criteria):A.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 MRIorCT scan.
3.In very early stageto intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦10, HCC tumor size ≦15 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score[1]≦8.
4.Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
5.Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
6.Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound) and non-treated before.
7.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 subject fully recovered from prior therapyas judged by PI
C.Surgery: After subject fully recovered from prior therapyas judged by PI
8.Patients able to understand, willing to acceptand cooperate with all clinical trial practices.
9.Willing to sign a written informed consent form
1.Age of over 20 years(or according to local legal definition of majority).
2.Patients diagnosed of HCC (Meet at least ONE of the following criteria):A.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 MRIorCT scan.
3.In very early stageto intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦10, HCC tumor size ≦15 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score[1]≦8.
4.Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
5.Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
6.Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound) and non-treated before.
7.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 subject fully recovered from prior therapyas judged by PI
C.Surgery: After subject fully recovered from prior therapyas judged by PI
8.Patients able to understand, willing to acceptand cooperate with all clinical trial practices.
9.Willing to sign a written informed consent form
Exclusion Criteria
Exclusion Criteria
1.Major branch of portal vein has been invaded by HCC,extrahepatic metastasis or other malignant tumors.
2.Eligible for curative surgery or transplant asjudged by PI.
3.Evidences of decompensation (Meet at least ONE of the following criteria):-Total Bilirubin > 2mg/dL-INR > 1.7-Child-Pugh score > 9 -refractory ascites -active bleeding -hepatic encephalopathy -severe infection
4.Any of the followingfindings (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 >480 milliseconds (ms) (CTCAEgrade 1) 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< 60 ml/min/1.73m2and/orcreatinine > 1.5x ULN),or patients is plannedto accept any renal replacement therapy during treatment visits.
-Diagnosed with hyperthyroidism or receiving treatment for hyperthyroidism.Has unstable thyroid function as judged by thePI(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.
5.Any of the following laboratoryfindings:
WBC < 3000 /μL
Platelets < 50,000/μL
Hgb <8.5 g/dL
AST >5x ULN
ALT >5x ULN
6.Performance status Eastern Cooperative Oncology Group (ECOG)of 2or more.
7.Patients whose blood vessel are too difficult to perform TACE procedureas judged by PI.
8.TACE procedure would be performed in areas of the liver where bile ducts are dilatedas judged by PI.
9.Prominent Hepatic arteriovenous (AV)shunt, as judged by PI.
10.Non-targeted area may be endangered during TACEprocedure, as judged by PI.
11.Patients, who have ever accepted TACE therapy, and cannot gain extra benefits from furtherembolization treatment.
12.Number of HCC tumors more than 10.
13.Allergyor contraindicationto iodine, Lipiodol, doxorubicin, allowed contrast agents, allowed Gelfoam suppositoriesor allowed artery hemostats.
14.Pregnant females or lactating females.
15.Male or female subjects with fertility who are unwilling to perform highly effective contraception method.
16.Subjects who, in the opinion of the investigator, are not suitable to participate inthe trial for whatever reason.
1.Major branch of portal vein has been invaded by HCC,extrahepatic metastasis or other malignant tumors.
2.Eligible for curative surgery or transplant asjudged by PI.
3.Evidences of decompensation (Meet at least ONE of the following criteria):-Total Bilirubin > 2mg/dL-INR > 1.7-Child-Pugh score > 9 -refractory ascites -active bleeding -hepatic encephalopathy -severe infection
4.Any of the followingfindings (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 >480 milliseconds (ms) (CTCAEgrade 1) 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< 60 ml/min/1.73m2and/orcreatinine > 1.5x ULN),or patients is plannedto accept any renal replacement therapy during treatment visits.
-Diagnosed with hyperthyroidism or receiving treatment for hyperthyroidism.Has unstable thyroid function as judged by thePI(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.
5.Any of the following laboratoryfindings:
WBC < 3000 /μL
Platelets < 50,000/μL
Hgb <8.5 g/dL
AST >5x ULN
ALT >5x ULN
6.Performance status Eastern Cooperative Oncology Group (ECOG)of 2or more.
7.Patients whose blood vessel are too difficult to perform TACE procedureas judged by PI.
8.TACE procedure would be performed in areas of the liver where bile ducts are dilatedas judged by PI.
9.Prominent Hepatic arteriovenous (AV)shunt, as judged by PI.
10.Non-targeted area may be endangered during TACEprocedure, as judged by PI.
11.Patients, who have ever accepted TACE therapy, and cannot gain extra benefits from furtherembolization treatment.
12.Number of HCC tumors more than 10.
13.Allergyor contraindicationto iodine, Lipiodol, doxorubicin, allowed contrast agents, allowed Gelfoam suppositoriesor allowed artery hemostats.
14.Pregnant females or lactating females.
15.Male or female subjects with fertility who are unwilling to perform highly effective contraception method.
16.Subjects who, in the opinion of the investigator, are not suitable to participate inthe trial for whatever reason.
The Estimated Number of Participants
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Taiwan
90 participants
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Global
0 participants
