UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of medical treatment for advanced hepatocellular carcinoma
Acronym	Medical treatment for HCC
Scientific Title	Efficacy and safety of medical treatment for advanced hepatocellular carcinoma
Scientific Title:Acronym	Medical treatment for HCC
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of medical treatment for advanced hepatocellular carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Time to progression, Progression-free survival, anti-tumor effect, adverse event, complication, prognostic factor, predictive factor

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	Clinically or pathologically diagnosed hepatocellular carcinoma Twenty or more years old Written informed consent
Key exclusion criteria	Mental disorder Inappropriate for paticipating the clinical study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Yamashita
Organization	Kanazawa University Hospital
Division name	Department of Gastroenterology
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa
TEL	076-265-2235
Email	ytatsuya@m-kanazawa.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Terashima
Organization	Kanazawa University Hospital
Division name	Department of Gastroenterology
Zip code	920-8641
Address	13-1, Takaramachi, Kanazawa
TEL	076-265-2235
Homepage URL
Email	tera@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University Hospital
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	Certified Review Board, Kanazawa University
Address	13-1, Takaramachi, Kanazawa
Tel	076-265-2834
Email	hpsangak@adm.kanazawa-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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 29 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	2017 Year 06 Month 22 Day
Date of IRB	2017 Year 05 Month 24 Day
Anticipated trial start date	2017 Year 06 Month 22 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Collect information about clinical, radiological, pathological, molecularbiological, and immunological findings of the patients, and investigate the impact of these factors on safety and efficacy of medical treatment for hepatocellular carcinoma.

Management information
Registered date	2017 Year 07 Month 29 Day
Last modified on	2019 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032536