UMIN-CTR Clinical Trial

Basic information
Public title	Combination of molecularly-targeted therapy with stereotactic body radiotherapy in hepatocellular carcinoma with major vascular invasion
Acronym	Combination of molecularly-targeted therapy with SBRT in HCC with MVI
Scientific Title	Combination of molecularly-targeted therapy with stereotactic body radiotherapy in hepatocellular carcinoma with major vascular invasion
Scientific Title:Acronym	Combination of molecularly-targeted therapy with SBRT in HCC with MVI
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the safety and efficacy of the novel combination therapy of molecularly-targeted therapy with SBRT in patients having HCC with MVI.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety; occurrence rate of adverse events, occurrence rate of adverse events of grade 3 or more.
Key secondary outcomes	Efficacy; overall survival rate, progression-free survival, response rate, disease control rate

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 Other
Interventions/Control_1	1) Stereotactic body radiotherapy, 48Gy/4Fr toward the portion of vascular invasion of the tumor. 2) Seven to 28 days after radiotherapy, the molecularly-targeted agent is started. The sorts of molecularly-targeted agents, that can be selected for this study, are sorafenib (at a dose of 800 mg daily), regorafenib (at a dose of 160 mg daily for the first 3 weeks of each 4-week cycle) or lenvatinib (at a dose of 120 mg daily in patients of body weight of 60 kg or more, or 80 mg daily in patients of body weight of less than 60 kg). The treatment interruption and dose reduction are allowed to manage drug toxicity.
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	The eligible subject must; 1) Be able to provide written informed consent from the subject person. 2) Have no previous molecularly-targeted therapies or systemic chemotherapies. 3) Have an ECOG-PS 0 or 1. 4) Have the liver function of a Child-Pugh class A (5-6 points), or Child-Pugh score 7 points with serum albumin of 3.0-3.5 g/dl and prothrombin time of 60-70%. 5) Fulfill the following the values of laboratory testings within 14 days prior to the trial registration. Neutrophils > 1500/mm^3, Hemoglobin > 8.5 g/dl, Platelets > 60000/mm^3, AST < x5 ULN, ALT < x5 ULN, Serum creatinine < 1.3 mg/dl, Creatinine clearance < 60 ml/min. 6) Received no treatments for HCC within 28 days prior to the trial registration. 7) Have a predicted life expentancy of 8 weeks or more.
Key exclusion criteria	The subject must be excluded if the subject; 1) Has the hepatic encephalopathy 2) Has the uncontrollable hypertension, heart failure, ischemic heart disease or arrhythmia. 3) Has had the acute myocardial infarction in the last 6 months. 4) Has the synchronous malignancies of other organs, or has had the metachronous ones in the last 2 years. 5) Has the serious psychiatric disorder or a serious decline in cognitive function. 6) Is pregnant or breastfeeding, or a female expecting to conceive a child. 7) Is judged to be inappropriate for the entry of this trial in the opinion of the treating investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Ohkawa
Organization	Osaka International Cancer Institute
Division name	Department of Hepatobiliary and Pancreatic Oncology
Zip code	5418567
Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL	81-6-6945-1181
Email	kazuyoshi.ohkawa@oici.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Ohkawa
Organization	Osaka International Cancer Institute
Division name	Department of Hepatobiliary and Pancreatic Oncology
Zip code	5418567
Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL	81-6-6945-1181
Homepage URL
Email	kazuyoshi.ohkawa@oici.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel	0669451181
Email	kazuyoshi.ohkawa@oici.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	2018 Year 01 Month 09 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 11 Month 01 Day
Date of IRB	2017 Year 09 Month 07 Day
Anticipated trial start date	2018 Year 01 Month 09 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 07 Day
Last modified on	2021 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035059