Clinical Trials List
Protocol NumberLT002
NCT Number(ClinicalTrials.gov Identfier)N/A
Completed
2016-01-01 - 2023-08-01
Phase I
Not yet recruiting4
ICD-10C22.0
Liver cell carcinoma
PHASE I DOSE-ESCALATING STUDY OF INTRAARTERIAL ADMINISTRATION OF TIRAPAZAMINE FOLLOWED BY TRANSARTERIAL EMBOLIZATION (TAE) FOR TREATMENT OF HEPATOCELLULAR CARCINOMA
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Trial Applicant
CHEERY PHARMA CO., LTD.
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Sponsor
Cheery Pharma Co., Ltd.
-
Trial scale
Taiwan Multiple Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 李祥麟 Digestive System Department
- 彭正明 Division of General Surgery
- 汪奇志 Digestive System Department
- 蔡明璋 Digestive System Department
- 楊耀坤 Division of General Surgery
- 彭正明醫師 Division of General Surgery
- 林俊哲 Digestive System Department
- 黃馨慧 Digestive System Department
- 陳宣怡 Division of Family Medicine
- 楊耀坤醫師 Division of General Surgery
- 張明輝 Digestive System Department
- 陳智維 Digestive System Department
- 林敬斌 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Sheng-Shun Yang Digestive System Department
- 張碧倚 Division of Radiology
- 葉宏仁 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- JA-DER LIANG 内科
- 蘇東弘 内科
- Ming-Chih Ho Division of General Surgery
- PEI-JER CHEN 内科
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Hepatocellular Carcinoma (HCC)
Objectives
Determine the recommended phase 2 dose of intraarterial tirapazamine combined
with trans-arterial embolization (TAE) in hepatocellular carcinoma (HCC)
Determine the pharmacokinetics of tirapazamine when combined with TAE
Determine the toxicity of tirapazamine when combined with TAE
Evaluate the preliminary efficacy of the combination of tirapazamine and TAE by
the rate of CR and ORR of the target lesion in the embolization territory, duration
of response
Test Drug
Tirapazamine
Active Ingredient
Tirapazamine
Dosage Form
IVT
Dosage
0.7 mg/mL
Endpoints
1. Primary endpoint(s):
The primary objective of this trial is to determine the recommended phase 2 dose of
intraarterial tirapazamine combined with transarterial embolization (TAE) in hepatocellular
carcinoma
2. Secondary endpoints:
Determine the pharmacokinetics of tirapazamine when combined with TAE
Determine the toxicity of tirapazamine when combined with TAE
Determine the preliminary efficacy of intravenous tirapazamine when combined with
TAE by the rate of complete response (CR) and overall response rate (ORR) in the
target lesions in the embolization territory, and duration of response
The primary objective of this trial is to determine the recommended phase 2 dose of
intraarterial tirapazamine combined with transarterial embolization (TAE) in hepatocellular
carcinoma
2. Secondary endpoints:
Determine the pharmacokinetics of tirapazamine when combined with TAE
Determine the toxicity of tirapazamine when combined with TAE
Determine the preliminary efficacy of intravenous tirapazamine when combined with
TAE by the rate of complete response (CR) and overall response rate (ORR) in the
target lesions in the embolization territory, and duration of response
Inclution Criteria
Inclusion Criteria
1. Confirmed hepatocellular carcinoma > 10 mm with a characteristic 3 or 4-phase CT or
dynamic contrast enhanced MRI showing intense arterial uptake followed by “washout” of
contrast in the venous-delayed phases per American Association for the Study of Liver
Disease (AASLD) criteria.
2. Age 20-80, ECOG 0-1 with no known major cardiac, pulmonary or renal dysfunction.
3. Patients with HCC who are candidates for TAE or TACE. The largest tumor nodule should
be less than 10 cm in the largest diameter. The total volume of tumor cannot exceed 50% of
liver. If the number of tumor lesions is 5 or higher, all lesions needs to be within the same
lobe.
4. Patients have no tumor invasion to the main portal vein branch or thrombosis in portal vein.
No lymph node involvement or distant metastasis for HCC.
5. For patients with HCC at caudate lobe, the tumor supplying vessel(s) needs to be identified
and accessed for embolization. If during the pre-TAE arteriogram, tumor lesions cannot be
identified by tumor stain upon injection of contrast, patients should be excluded during the
procedure.
6. ANC no less than 1500 /µL. Hemoglobin ≥ 8.5 gm/dL. Platelets no less than 60,000 /µL.
Creatinine no more than 2.0 mg/dL. AST, ALT no more than 5 X upper limit of normal.
Bilirubin no more than 2.0 mg/dl. Liver function in Child-Pugh score 5-7. PT prolongation ≤
4 sec above upper limit of normal.
7. Pregnant and lactating woman are excluded.
8. Prior local therapies such as surgical resection, radiofrequency ablation, TAE/TACE or
alcohol injection are allowed as long as residual lesions present and the patients are still
candidates for TAE. All prior therapy must be at least 4 weeks prior to enrollment and free
from treatment-related toxicity.
9. Patients who are able and willing to understand and sign the inform consent form.
10. Men and women of child-bearing age need to commit to using two methods of contraception
simultaneously to avoid pregnancy.
1. Confirmed hepatocellular carcinoma > 10 mm with a characteristic 3 or 4-phase CT or
dynamic contrast enhanced MRI showing intense arterial uptake followed by “washout” of
contrast in the venous-delayed phases per American Association for the Study of Liver
Disease (AASLD) criteria.
2. Age 20-80, ECOG 0-1 with no known major cardiac, pulmonary or renal dysfunction.
3. Patients with HCC who are candidates for TAE or TACE. The largest tumor nodule should
be less than 10 cm in the largest diameter. The total volume of tumor cannot exceed 50% of
liver. If the number of tumor lesions is 5 or higher, all lesions needs to be within the same
lobe.
4. Patients have no tumor invasion to the main portal vein branch or thrombosis in portal vein.
No lymph node involvement or distant metastasis for HCC.
5. For patients with HCC at caudate lobe, the tumor supplying vessel(s) needs to be identified
and accessed for embolization. If during the pre-TAE arteriogram, tumor lesions cannot be
identified by tumor stain upon injection of contrast, patients should be excluded during the
procedure.
6. ANC no less than 1500 /µL. Hemoglobin ≥ 8.5 gm/dL. Platelets no less than 60,000 /µL.
Creatinine no more than 2.0 mg/dL. AST, ALT no more than 5 X upper limit of normal.
Bilirubin no more than 2.0 mg/dl. Liver function in Child-Pugh score 5-7. PT prolongation ≤
4 sec above upper limit of normal.
7. Pregnant and lactating woman are excluded.
8. Prior local therapies such as surgical resection, radiofrequency ablation, TAE/TACE or
alcohol injection are allowed as long as residual lesions present and the patients are still
candidates for TAE. All prior therapy must be at least 4 weeks prior to enrollment and free
from treatment-related toxicity.
9. Patients who are able and willing to understand and sign the inform consent form.
10. Men and women of child-bearing age need to commit to using two methods of contraception
simultaneously to avoid pregnancy.
Exclusion Criteria
Exclusion Criteria
1. Patients who have had a liver transplantation
2. Patients who have major medical problems such as cardiac, pulmonary (COPD requiring
constant oxygen), renal (creatinine over 2.0) diseases, active infectious diseases (except
chronic Hepatitis B or C), non-healing ulceration or a history of encephalopathy or large
amount of ascites.
3. Patients who are known to have uncontrolled hepatitis B or C with a high viral DAN or RNA
titer over 3 X ULN should be treated before enrolled into the study.
4. Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room
air.
5. Patients with evidence of arterial insufficiency or microangiopathy in any organ due to any
reason, such as diabetes, which could lead to distal extremity hypoxia, as evidenced by any
gangrenous change in distal limbs or requiring resection for this reason.
6. Patients on interferon treatment need to have a 2-week washout period from Day 1.
7. Patients with known HIV infection
8. Patients with major gastrointestinal bleeding in the prior 2 months of enrollment.
9. Patient on chronic anti-coagulation therapy that is considered a risk for any invasive
procedure such as TAE.
10. Patients with known diagnosis of cancer other than HCC, unless the cancer is considered
cured by the treating physician due to no evidence of recurrence for more than 5 years, or
localized and resected early-stage cancer such as basal cell carcinoma, resected early stage
prostate cancer, superficial melanoma, breast ductal carcinoma in situ, without evidence for
recurrence for more than a year.
11. Patients who are pregnant or lactating are not allowed in this study
12. Patients with QTc interval > 470 msec or those known to have congenital long QTc
syndrome.
13. Patients who take any medication that is known to prolong the QT interval and/or are
associated with a risk of Torsades de Pointes will need to have a washout period of 7 days
prior to the first dose.
14. Patients on anti-platelet agents such as aspirin, non-steroidal anti-inflammatory drugs
(NSAIDs) or other platelet inhibitors such as clopidogrel, vorapaxar, and dipyridamole will
need to have a washout period of 7 days before embolization.
1. Patients who have had a liver transplantation
2. Patients who have major medical problems such as cardiac, pulmonary (COPD requiring
constant oxygen), renal (creatinine over 2.0) diseases, active infectious diseases (except
chronic Hepatitis B or C), non-healing ulceration or a history of encephalopathy or large
amount of ascites.
3. Patients who are known to have uncontrolled hepatitis B or C with a high viral DAN or RNA
titer over 3 X ULN should be treated before enrolled into the study.
4. Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room
air.
5. Patients with evidence of arterial insufficiency or microangiopathy in any organ due to any
reason, such as diabetes, which could lead to distal extremity hypoxia, as evidenced by any
gangrenous change in distal limbs or requiring resection for this reason.
6. Patients on interferon treatment need to have a 2-week washout period from Day 1.
7. Patients with known HIV infection
8. Patients with major gastrointestinal bleeding in the prior 2 months of enrollment.
9. Patient on chronic anti-coagulation therapy that is considered a risk for any invasive
procedure such as TAE.
10. Patients with known diagnosis of cancer other than HCC, unless the cancer is considered
cured by the treating physician due to no evidence of recurrence for more than 5 years, or
localized and resected early-stage cancer such as basal cell carcinoma, resected early stage
prostate cancer, superficial melanoma, breast ductal carcinoma in situ, without evidence for
recurrence for more than a year.
11. Patients who are pregnant or lactating are not allowed in this study
12. Patients with QTc interval > 470 msec or those known to have congenital long QTc
syndrome.
13. Patients who take any medication that is known to prolong the QT interval and/or are
associated with a risk of Torsades de Pointes will need to have a washout period of 7 days
prior to the first dose.
14. Patients on anti-platelet agents such as aspirin, non-steroidal anti-inflammatory drugs
(NSAIDs) or other platelet inhibitors such as clopidogrel, vorapaxar, and dipyridamole will
need to have a washout period of 7 days before embolization.
The Estimated Number of Participants
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Taiwan
48 participants
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Global
0 participants
