Trial Title:
TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX)
NCT ID:
NCT06114082
Condition:
Hepatocellular Carcinoma
Liver Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Doxorubicin
Idarubicin
Chlorotrianisene
Conditions: Keywords:
Hepatocellular carcinoma
Transarterial chemoembolization
Doxorubicin
Idarubicin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
IDA-TACE
Description:
Stable chemoemulsion will be produced by dissolving 10 mg of idarubicin powder (Zavedos;
Pfizer, New York, NY, USA) in 2.5 mL of an iodinated contrast agent. This solution will
then be mixed with 10 mL of iodized oil (Lipiodol Ultrafluid; Guerbet, Villepinte,
France) using a three-way stopcock. This chemoemulsion will be prepared in aliquots (0.8
mL of chemoemulsion in each 1 mL syringe) and injected until the embolization endpoint is
achieved.
Arm group label:
IDA-TACE
Other name:
Conventional TACE using idarubicin chemoemulsion
Intervention type:
Procedure
Intervention name:
DOX-TACE
Description:
Stable chemoemulsion will be produced by dissolving 50 mg of doxorubicin powder
(Adriamycin RDF; Ildong Pharmaceutical, Seoul, Republic of Korea) in 2.5 mL of an
iodinated contrast agent. This solution will then be mixed with 10 mL of iodized oil
(Lipiodol Ultrafluid; Guerbet, Villepinte, France) using a three-way stopcock. This
chemoemulsion will be prepared in aliquots (0.8 mL of chemoemulsion in each 1 mL syringe)
and injected until the embolization endpoint is achieved.
Arm group label:
DOX-TACE
Other name:
Conventional TACE using doxorubicin chemoemulsion
Summary:
Little is known about whether the types of chemotherapeutic agents affect the efficacy of
transarterial chemoembolization in patients with hepatocellular carcinoma. Although
doxorubicin is the most commonly-used chemotherapeutic agent in the world, idarubicin is
recently in the spotlight after promising results of the in vitro and prospective
single-arm studies. On the other hand, there are many reports showing that the type of
chemotherapeutic agents does not significantly alter the efficacy of transarterial
chemoembolization. This is a randomized-controlled trial to show the non-inferiority of
idarubicin compared to doxorubicin in patients with hepatocellular carcinoma who receive
transarterial chemoembolization as the first-line treatment.
Detailed description:
Eligible patients will be randomly allocated either in the IDA-cTACE or DOX-cTACE group,
and the randomization can be stratified by Child-Pugh class. Each patient will be treated
by conventional chemoembolization using a microcatheter and chemoemulsion. For the
chemoemulsion preparation method, 10 mg of idarubicin powder (IDA-cTACE) or 50 mg of
doxorubicin powder (DOX-cTACE) will be dissolved by 2.5 mL of iodinated contrast media,
and then mixed with 10 mL of iodized poppy seed oil (Lipiodol; Lipiodol Ultrafluid,
Guerbet, France). The amount of chemoemulsion administered to each patient will be
determined by an operator regarding tumor size, vascularity, etc. Additional embolization
will be performed using calibrated gelatin sponge particles usually 100-350 µm until the
arterial flow is almost stopped. Afterwards, Patients will be evaluated at 1, 3, and 6
months after the initial treatment, but the follow-up can be individualized at the
discretion of hepatologists or hepatic surgeons blinded to the treatment allocation. In
cases of residual or recurred tumor, additional treatments will be determined by the
blinded hepatologists or hepatic surgeons. Once a patient with residual or recurred tumor
receives repetitive TACE, the same drug (idarubicin or doxorubicin) used at the initial
TACE will be used for re-treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adults aged 19 or above.
2. Patients diagnosed with HCC either histologically and/or radiologically (LI-RADS 4
or 5).
3. Patients with five or fewer tumors.
4. Patients in which the largest tumor is 5 cm or less in diameter.
5. Patients with no prior treatment experience for HCC.
6. Patients categorized as Child-Pugh class A or B.
7. Patients with an Eastern Cooperative Oncology Group performance status of 2 or
below.
8. Patients without severe functional abnormalities of major organs: the following
results from a blood test conducted within a month prior to the procedure must be
satisfied:
- WBC count ≤ 12,000 / mm3
- Absolute neutrophil count ≥ 1,500 /mm3
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 3.0 mg/dL
- eGFR ≥ 30 mL/min/1.73 m2
- Patients deemed clinically most suitable to receive TACE through hepatologist,
hepatic surgeon, or multidisciplinary consultation: patients for whom other
treatments such as liver transplantation/surgery/ablation are realistically
impossible or, even if technically possible, do not have significant clinical
benefits compared to TACE.
- Patients who have understood sufficiently about this clinical trial and have
given written consent to participate.
- Fertile women capable of effective contraception for at least 6.5 months after
TACE, and men with fertile female partners capable of effective contraception
for at least 3.5 months after TACE.
Exclusion Criteria:
1. Patients with HCC involving the portal vein or hepatic vein.
2. Patients with extrahepatic spread of HCC
3. Patients diagnosed with a cancer other than HCC within 2 years of enrollment.
4. Patients who have undergone a biliary-intestinal anastomosis.
5. Patients for whom the use of idarubicin or doxorubicin is contraindicated (including
severe heart failure, arrhythmia, hypersensitivity to anthracycline chemotherapy,
pregnant or nursing women, etc.).
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jin Woo Choi, MD, PhD
Investigator:
Last name:
Jin Woo Choi, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Hyo-Cheol Kim, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jin Wook Chung, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Do Hoon Kim, MD
Email:
Sub-Investigator
Start date:
April 28, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Guerbet
Agency class:
Industry
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06114082
