UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021457 |
|---|---|
| Receipt number | R000024743 |
| Scientific Title | Hepatic Artery Embolization with Microsphere for Large Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2016/03/12 |
| Last modified on | 2024/03/18 11:56:15 |
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Basic information
Public title
Hepatic Artery Embolization with Microsphere for Large Hepatocellular Carcinoma
Acronym
HAMLET study
Scientific Title
Hepatic Artery Embolization with Microsphere for Large Hepatocellular Carcinoma
Scientific Title:Acronym
HAMLET study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of the transarterial embolization using microsphere for the treatment of large hepatocellular carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate of large hepatocellular carcinoma (3 months)
Key secondary outcomes
Safety, Response rate of all hepatocellular carcinomas, Progression free survival, Survival rate (1-year), Overall survival rate, Hospital stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transarterial embolization using microsphere
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) Treatment-naive hepatocellular carcionma
2) Five or fewer tumors, At least one tumor has 5 cm or lager to 10 cm or less in maximum diameter
3) No invasion to veins and biliary duct
4) Child-Pugh score <= 8
5) Liver tumor seems to be the most important factor of prognosis
6) No candidate for surgery or ablation therapy
7) Function of liver, kidney, and bone marrow are normal
8) Over 20 years old
9) ECOG performance status: 0 or 1
10) Expected survival time over 12 weeks
11) Written informed consent
Key exclusion criteria
1) History of the surgery or endoscopic treatment of the biliary duct
2) Sever arterioportal shunt or arteriovenous shunt
3) Sever stenosis or occlusion of the hepatic artery
4) History of rupture of hepatocellular carcionma
5) Treatment refractory pleural effusion or ascites
6) Sever complication:
heart failure, angina pectoris, arrhythmia
myocardial infarction
duplicate active cancer
active infection
active gastrointestinal hemorrhage
hepatic encephalopathy, mental disorder
iodine allergy, sever drug allergy
7) Pregnant woman or woman who want to be pregnant
8) Qualified ineligible patients being this clinical trial by responsible doctor
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Yamakado |
Organization
Hyogo college of medicine
Division name
Radiology
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6362
Ko-yamakado@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujimori |
Organization
Mie University School of Medicine
Division name
Radiology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
fujimorim@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
Mie University
Address
Edobashi 2-174
Tel
059-232-1111
s-kenkyu@mo.medic.mie-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
三重大学（中塚豊真）、兵庫医科大学（高木治行）、奈良県立医科大学（佐藤健司）、手稲渓仁会病院（児玉芳尚）、名古屋市立大学（下平政史）、愛知県がんセンター中央病院（稲葉吉隆）、近畿大学（鶴崎正勝）、大阪市立大学（山本晃）、大阪大学（大須賀慶吾）（2019年3月25日現在）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 12 | 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
25
Results
Response rates of large HCC at 3 months of treatment were 39% (95% CI: 22-59%, PR: 39%) and 83% (95% CI: 63-93%, CR: 17%, PR: 65%) for RECIST and mRECIST evaluation, respectively, and best overall large tumor response rate was 39% (95 CI: 22-59%, PR: 39%) and 83% (95% CI: 63-93%, CR: 26%, PR: 57%), respectively.
No local recurrence was observed during follow-up (median 2.5 years) for lesions that were CR in mRECIST.
The 1-, 3-, and 5-year overall survival rates were 96%, 38%, and 38%, respectively.
Results date posted
| 2024 | Year | 03 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to analytical and statistical processing in progress.
Date of the first journal publication of results
Baseline Characteristics
There were 2 dropouts, and 23 patients with mean age of 81 years completed the protocol. Each patient had one large HCC (mean 6.8 cm diameter, 5.1 cm to 9.7 cm), 91% Child-Pugh A and 43% BCLC stage A.
Participant flow
There were 2 dropouts, and 23 patients with mean age of 81 years completed the protocol. Each patient had one large HCC (mean 6.8 cm diameter, 5.1 cm to 9.7 cm), 91% Child-Pugh A and 43% BCLC stage A.
Adverse events
No treatment-related deaths were observed.
Accordin to CTCAEv4.0, adverse events of Grade 3 or higher occurred in 48% of patients with AST elevation, 26% with ALT elevation, 26% with ALP elevation, and 4% each with low platelet count and hyponaemia and hyperglycemia, but no post embolic syndrome of Grade 3 or higher occurred.
Outcome measures
Response rates of large HCC at 3 months of treatment were 39% (95% CI: 22-59%, PR: 39%) and 83% (95% CI: 63-93%, CR: 17%, PR: 65%) for RECIST and mRECIST evaluation, respectively, and best overall large tumor response rate was 39% (95 CI: 22-59%, PR: 39%) and 83% (95% CI: 63-93%, CR: 26%, PR: 57%), respectively.
No local recurrence was observed during follow-up (median 2.5 years) for lesions that were CR in mRECIST.
Plan to share IPD
No.
IPD sharing Plan description
No.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 12 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 12 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 12 | Day |
Other
Other related information
On September 28, 2020, the target number of enrolled patients was reached with 25 cases. After the 1-year follow-up period, the final data collection was conducted.
Preliminary results were reported at the 71st Chubu and the 72nd Kansai IVR Study Meetings.
Management information
Registered date
| 2016 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024743
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