UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039887
Receipt number R000045485
Scientific Title Evaluation of the efficacy of molecular targeted drugs using biopsy samples in patients with advanced hepatocellular carcinoma
Date of disclosure of the study information 2020/03/20
Last modified on 2024/02/16 12:33:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of the efficacy of molecular targeted drugs using biopsy samples in patients with advanced hepatocellular carcinoma

Acronym

Evaluation of the efficacy of targeted drugs using biopsy samples from HCC

Scientific Title

Evaluation of the efficacy of molecular targeted drugs using biopsy samples in patients with advanced hepatocellular carcinoma

Scientific Title:Acronym

Evaluation of the efficacy of molecular targeted drugs using biopsy samples in patients with advanced 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

To assess the relationship between the histological change in HCC obtained at Week 4 and the subsequent survival outcomes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Histological treatment effects obtained four weeks after the start of molecular targeted drugs

Key secondary outcomes



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

Maneuver

Interventions/Control_1

liver tumor biopsy

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

Patients with advanced HCC in whom the first-line molecular targeted therapy or combined molecular targeted plus immune checkpoint inhibitor therapy begins within four weeks

Key exclusion criteria

Patients with allergy to lenvatinib, sorafenib, bevacizumab, atezolizumab, local anesthetics, or analgesics
Patients with severe ascites, severe renal failure, severe anemia, severe thrombocytopenia, jaundice, or coagulation disorder
Patients who need to take anticoagulants or anti-platelet drugs continuously
Patients with severe cognitive dysfunction or psychiatric disorders
Patients with severe heart failure
Pregnant or nursing mothers, woman who desire to bear children

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shiro
Middle name
Last name Oka

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology

Zip code

734-8551

Address

Kasumi 1-2-3, Minami-ku, Hiroshima, Japan

TEL

082-257-5190

Email

oka4683@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Tomokazu
Middle name
Last name Kawaoka

Organization

Hiroshima University Hospital

Division name

Department of Gastroenterology

Zip code

734-8551

Address

Kasumi 1-2-3, Minami-ku, Hiroshima, Japan

TEL

082-257-5193

Homepage URL


Email

kawaokatomo@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Metabolism, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology, Hiroshima 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

Independent Ethics Committee, Hiroshima University Hospital

Address

Kasumi 1-2-3, Minami-ku, Hiroshima, Japan

Tel

082-257-1576

Email

iryo-seisaku@office.hiroshima-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

2020 Year 03 Month 20 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

2020 Year 03 Month 19 Day

Date of IRB

2020 Year 03 Month 19 Day

Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2027 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

2020 Year 03 Month 20 Day

Last modified on

2024 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name