Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
NCT ID: NCT06904196
Last Updated: 2025-04-29
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
PHASE2
78 participants
INTERVENTIONAL
2025-04-01
2029-03-31
Brief Summary
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Detailed Description
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78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN.
Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT.
The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Len+SIRT
Lenvatinib plus SIRT
Lenvatinib plus SIRT
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
LEN
Lenvatinib alone
Lenvatinib
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.
Interventions
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Lenvatinib plus SIRT
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
Lenvatinib
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
* At least one measurable intrahepatic target lesion
* Child-Pugh class A/B
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Tumor extent \<70% liver occupation
* Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
* Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
* Life expectancy of at least 3 months
Exclusion Criteria
* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
* Vena cava invasion
* Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
* History of organ and cell transplantation
* History of esophageal or gastric variceal bleeding
* History of hepatic encephalopathy
* History of other malignancies
* Human immunodeficiency virus infection
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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Principal Investigators
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Mingyue Cai, Dr.
Role: STUDY_CHAIR
Second Affiliated Hospital of Guangzhou Medical University
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-21
Identifier Type: -
Identifier Source: org_study_id
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