Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
NCT ID: NCT06492395
Last Updated: 2025-01-29
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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RECRUITING
PHASE3
178 participants
INTERVENTIONAL
2024-08-01
2027-07-31
Brief Summary
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Detailed Description
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178 patients with large HCC (\> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the Len+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the Len+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.
The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Len+DEB-TACE+HAIC
Patients will receive the combination treatment of Len+DEB-TACE+HAIC.
Len+DEB-TACE+HAIC
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.
During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Len+DEB-TACE
Patients will receive the combination treatment of Len+DEB-TACE.
Len+DEB-TACE
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Interventions
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Len+DEB-TACE+HAIC
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.
After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.
During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Len+DEB-TACE
For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.
Eligibility Criteria
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Inclusion Criteria
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
* life expectancy of at least 3 months
Exclusion Criteria
* accompanied with vena cava tumor thrombus
* central nervous system involvement
* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
* history of other malignancies
* uncontrollable infection
* history of HIV
* history of organ or cells transplantation
* prothrombin time prolongation \>4 s
18 Years
75 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-18
Identifier Type: -
Identifier Source: org_study_id
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