UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034611
Receipt number R000038483
Scientific Title A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma
Date of disclosure of the study information 2018/10/23
Last modified on 2019/04/24 14:53:05

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Basic information

Public title

A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma

Acronym

Systemic chemotherapy for hepatocellular carcinoma: a prospective multicenter observational study

Scientific Title

A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma

Scientific Title:Acronym

Systemic chemotherapy for hepatocellular carcinoma: a prospective multicenter observational study

Region

Japan


Condition

Condition

hepatocellular carcinoma

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 effective biomarkers for predictive factors of therapeutic effect by evaluating patient backgrounds, anti-tumor effects, and long-term prognosis in patients treated with systemic chemotherapy for hepatocellular carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Anti-tumor effects and long-term prognosis in patients treated with systemic chemotherapy for hepatocellular carcinoma

Key secondary 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

(1) Patients with 20 years of age and older
(2) Patients expected to survive for more than 12 weeks
(3) Patients diagnosed as typical hepatocellular carcinoma by histological/cytological diagnosis or imaging diagnosis by dynamic CT (or MRI)
(4) Patients who are difficult for surgical resection or locoregional therapies and are indicated for systemic chemotherapy
(5) Patients with Eastern Cooperative Oncology Group performance status score of 0 or 1
(6) No contraindication to systemic chemotherapy, per the approved package insert of each medication

Key exclusion criteria

(1) Patients who do not give informed consent
(2) Patients who are not judged to be eligible for participation in this study by researchers

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

Yamadaoka 2-2, Suita city, Osaka

TEL

06-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Ryotaro
Middle name
Last name Sakamori

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

Yamadaoka 2-2, Suita city, Osaka

TEL

06-6879-3621

Homepage URL


Email

sakamori@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology

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 University Clinical Research Review Committee

Address

Yamadaoka 2-2, Suita city, Osaka

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-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

2018 Year 10 Month 23 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

2018 Year 10 Month 23 Day

Date of IRB

2018 Year 10 Month 23 Day

Anticipated trial start date

2018 Year 10 Month 23 Day

Last follow-up date

2023 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 10 Month 23 Day

Last modified on

2019 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name