TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT
NCT ID: NCT04967495
Last Updated: 2023-05-18
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
171 participants
INTERVENTIONAL
2021-07-09
2025-01-08
Brief Summary
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Detailed Description
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171 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-Len-I or TACE-Len using an 2:1 randomization scheme.
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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 TACE-Len-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TACE-Len-I
TACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
TACE-Len
TACE combined with lenvatinib
TACE combined with lenvatinib
TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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.
Interventions
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TACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE will be performed for the patients after randomization. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
TACE combined with lenvatinib
TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE 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.
Eligibility Criteria
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Inclusion Criteria
2. HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
3. Accompanied with tumor thrombus involving unilateral portal vein branch.
4. Child-Pugh class A or B.
5. Eastern Cooperative Group performance status (ECOG) score of 0-2.
6. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
7. Prothrombin time prolonged for less than 4s or international normalized ratio \< 1.7.
8. Neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L, and hemoglobin level ≥ 85g/L;
9. At least one measurable intrahepatic target lesion.
10. Life expectancy of at least 3 months.
Exclusion Criteria
2. Extrahepatic metastasis.
3. Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
4. Hepatic vein and/or vena cava invasion.
5. History of organ or cells transplantation.
6. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
7. History of other malignancies.
8. Serious medical comorbidities.
9. Female patients who are pregnancy or breastfeeding.
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-07
Identifier Type: -
Identifier Source: org_study_id
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