DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC
NCT ID: NCT04967482
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2021-07-09
2024-07-08
Brief Summary
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Detailed Description
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At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DEB-TACE
DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment.
Drug-eluting bead transarterial chemoembolization (DEB-TACE)
The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.
cTACE
cTACE will be performed for the patients who choose cTACE as the primary treatment.
Conventional transarterial chemoembolization (cTACE)
The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.
Interventions
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Drug-eluting bead transarterial chemoembolization (DEB-TACE)
The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.
Conventional transarterial chemoembolization (cTACE)
The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.
Eligibility Criteria
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Inclusion Criteria
2. The tumor lesion was only localized in one liver lobe.
3. Large HCC with single lesion \> 7 cm, or multiple lesions.
4. unresectable HCC evaluated by the surgeon team.
5. The patient is suitable for TACE treatment, which is evaluated by MDT.
6. At least one measurable intrahepatic target lesion.
7. Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
8. ECOG score of performance status ≤ 1 point.
9. Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils \>1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
10. Patients have the willingness to receive TACE as the conversion therapy for surgical resection.
Exclusion Criteria
2. Accompanied with hepatic vein and vena cava tumor thrombus.
3. The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
4. Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
5. Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
6. History of other malignancies.
7. Uncontrollable infection.
8. Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA \<10\^3 IU/mL.
9. HCV patients need to complete the anti-HCV therapy before they are enrolled.
10. History of HIV.
11. Allergic to the drugs involved in the research.
12. Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
13. History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
14. Those with bleeding tendency.
18 Years
70 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Locations
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the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MIIR-06
Identifier Type: -
Identifier Source: org_study_id
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