UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050223 |
|---|---|
| Receipt number | R000057193 |
| Scientific Title | Survey on the use of molecular targeted drugs for unresectable hepatocellular carcinoma. |
| Date of disclosure of the study information | 2023/02/02 |
| Last modified on | 2024/02/03 14:32:54 |
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Basic information
Public title
Survey on the use of molecular targeted drugs for advanced hepatocellular carcinoma.
Acronym
Investigation of molecular targeted drugs for liver cancer.
Scientific Title
Survey on the use of molecular targeted drugs for unresectable hepatocellular carcinoma.
Scientific Title:Acronym
Molecularly targeted drugs investigation for unresectable hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A multicentre, prospective, observational study to investigate the actual use and assess the efficacy and safety of molecularly targeted drugs in patients with unresectable hepatocellular carcinoma who are considered eligible for systemic anti-cancer treatment and for whom molecularly targeted drug therapy is selected under routine practice, with the primary objective of assessing safety in the overall population and in each of various populations based on patient background factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
After identifying patient selection and exclusion criteria, patients will be enrolled and observed until withdrawal of consent, patient death, last hospital visit (loss to follow-up) or end of study period (one year after last enrolled case). Safety will be investigated during this observation period.
Key secondary outcomes
Investigate patient background, treatment, efficacy and patient 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
All patients with a histological or clinical (imaging and tumour markers) diagnosis of hepatocellular carcinoma whose attending physician determines that the use of molecularly targeted drugs is appropriate in routine practice are eligible for the study.
Key exclusion criteria
Patients who indicated their intention not to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Sugimoto |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
0925413231
sugirie5@rr.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Sugimoto |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
0925413231
Homepage URL
sugirie5@rr.iij4u.or.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Rie Sugimoto
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center Ethics Committee
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
Tel
0925413231
sugimoto.rie.jw@mail.hosp.go.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
国立病院機構九州がんセンター(福岡県）、九州大学病院 肝臓・膵臓・胆道内科(福岡県）、国立病院機構九州医療センター (福岡県）、済生会福岡総合病院 (福岡県）、福岡市立病院機構福岡市民病院 (福岡県）、 飯塚病院 (福岡県）、国立病院機構小倉医療センター(福岡県）、製鉄八幡記念病院 (福岡県）、九州労災病院 消化器内科 (福岡県）、中津市立中津市民病院 (大分県）、原三信病院 (福岡県）、福岡中央病院 (福岡県）、国立病院機構福岡東医療センター (福岡県）、国立病院機構別府医療センター (福岡県）、福岡山王病院 (福岡県）、千早病院(福岡県）、博愛会病院 (福岡県）、 牟田病院(福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
CTCAE v4.0 Grade determination, serious/non-serious, drug-related or not, treatment details, outcome
observational examination criteria
Tumour assessment
Tumour assessment is performed according to RECIST Ver 1.1. Imaging should be performed by the same principal investigator/radiologist during the observation period.
Summary of assessment items
Safety
Efficacy
- Overall Survival (OS)
- Progression Free Survival/PFS
- Time to Progression/TTP
- Response Rate/RR
- Disease Control Rate/DCR
- Tumour marker trends
Details of treatment
- Details of previous treatment
- Duration of molecular-targeted drug treatment
- Dose of molecular-targeted drug
- Reason for discontinuation of molecular-targeted drug treatment
- Description of post-treatment
Management information
Registered date
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057193
