UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063008 |
|---|---|
| Receipt number | R000072134 |
| Scientific Title | A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Pretreated Transarterial Chemoembolization (LEN-TACE): An Analysis of Efficacy and Prognostic Factors Based on Real-World Data |
| Date of disclosure of the study information | 2026/09/21 |
| Last modified on | 2026/09/21 12:51:33 |
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Basic information
Public title
A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Pretreated Transarterial Chemoembolization (LEN-TACE)
Acronym
A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Preceded Hepatic Artery Chemotherapy Embolization
Scientific Title
A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Pretreated Transarterial Chemoembolization (LEN-TACE): An Analysis of Efficacy and Prognostic Factors Based on Real-World Data
Scientific Title:Acronym
A Multicenter Retrospective Observational Study of Unresectable Hepatocellular Carcinoma Treated with Lenvatinib-Pretreated Transarterial Chemoembolization (LEN-TACE): An Analysis of Efficacy and Prognostic Factors Based on Real-World Data
Region
| Japan |
Condition
Condition
Unresectable Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct a multicenter, retrospective observational study of patients with unresectable HCC who underwent LEN-TACE therapy, with the aim of elucidating its efficacy, safety, and prognostic factors in real-world clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR, objective response rate
DCR, disease control rate
OS, overall survival
TTUP, time to untreatable progression
Safety
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with histologically or clinically unresectable hepatocellular carcinoma
(2) Patients who began prior LEN administration between January 1, 2019, and December 31, 2025
(3) Patients who underwent TACE within 4 weeks of starting LEN administration
(4) Patients whose hepatocellular carcinoma meets the criteria of tumor diameter of 10 cm or less and no more than 10 tumors
(5) Patients who have not received systemic therapy (including combination immunotherapy) or transarterial chemoembolization (TACE) prior to LEN-TACE
(6) Patients who have undergone TACE no more than twice prior to LEN-TACE
(7) Patients who have provided written informed consent via the informed consent form, or who have not expressed a desire to opt out of the study via the disclosure document
Key exclusion criteria
(1) Patients who have undergone systemic drug therapy for other malignant tumors within the past 5 years
(2) Patients participating in a clinical trial involving an intervention at the time of case registration (this does not apply to observational studies without an intervention)
(3) Patients deemed ineligible for participation in this study by the principal investigator or the attending physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Koga |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7561
hirokoga@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Koga |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7561
Homepage URL
hirokoga@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Clinical Research Center
Address
67 Asahi-machi, Kurume 830-0011, Japan
Tel
0942-35-3311
i_rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学医学部 消化器内科（福岡県）
産業医科大学 第三内科（福岡県）
九州医療センター 消化器内科（福岡県）
九州がんセンター 消化器・肝胆膵内科（福岡県）
九州大学大学院 消化器・総合外科（福岡県）
福岡大学医学部 消化器内科（福岡県）
大分大学医学部 消化器内科（大分県）
長崎大学大学院 消化器内科（長崎県）
長崎医療センター 臨床研究センター（長崎県）
熊本大学大学院 消化器内科（熊本県）
宮崎大学医学部 消化器内科（宮崎県）
佐賀大学医学部 肝臓・糖尿病・内分泌内科（佐賀県）
鹿児島大学大学院 消化器内科（鹿児島県）
琉球大学医学部 第一内科（消化器内科）（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PFS, OS, TTUP, Estimated using the Kaplan-Meier method to calculate the median survival time and 95% confidence interval.
ORR, DCR, Calculated based on RECIST or mRECIST criteria; rates are presented along with 95% confidence intervals.
Between-group comparisons (baseline and stratified analyses): The Mann-Whitney U test is used for between-group comparisons of continuous variables.
For comparisons of categorical variables, the X^2 test or Fisher's exact test will be used.
To identify factors influencing PFS, OS, and TTUP, univariate and multivariate analyses using the Cox proportional hazards model will be performed.
Multivariate analyses will include factors considered clinically important, as well as those showing statistical significance or a trend (e.g., P<0.1) in the univariate analysis.
Management information
Registered date
| 2026 | Year | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072134
