TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail
1 other identifier
interventional
171
1 country
1
Brief Summary
This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2021
CompletedStudy Start
First participant enrolled
July 9, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2025
CompletedMay 18, 2023
May 1, 2023
3.5 years
July 8, 2021
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
The time from date of randomization to death due to any cause.
2 years.
Secondary Outcomes (5)
Adverse events (AEs)
2 years.
Progression free survival (PFS) assessed by investigators according to Modified Response Evalutaion Criteria in Solid Tumors (mRECIST)
2 years.
Objective response rate (ORR) assessed by investigators according to mRECIST
2 years.
Disease control rate (DCR) assessed by investigators according to mRECIST
2 years.
Duration of portal patency
2 years.
Study Arms (2)
TACE-Len-I
EXPERIMENTALTACE combined with lenvatinib and iodion-125 seeds brachytherapy
TACE-Len
ACTIVE COMPARATORTACE combined with lenvatinib
Interventions
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 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
You may qualify if:
- Age between18 and 75 years.
- HCC confirmed by histopathology and/or cytology, or diagnosed clinically.
- Accompanied with tumor thrombus involving unilateral portal vein branch.
- Child-Pugh class A or B.
- Eastern Cooperative Group performance status (ECOG) score of 0-2.
- Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L.
- Prothrombin time prolonged for less than 4s or international normalized ratio \< 1.7.
- Neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L, and hemoglobin level ≥ 85g/L;
- At least one measurable intrahepatic target lesion.
- Life expectancy of at least 3 months.
You may not qualify if:
- Diffuse HCC.
- Extrahepatic metastasis.
- Tumor thrombus involving both the left and right branch of portal vein or main portal vein.
- Hepatic vein and/or vena cava invasion.
- History of organ or cells transplantation.
- Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy.
- History of other malignancies.
- Serious medical comorbidities.
- Female patients who are pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 19, 2021
Study Start
July 9, 2021
Primary Completion
January 8, 2025
Study Completion
January 8, 2025
Last Updated
May 18, 2023
Record last verified: 2023-05