UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043219
Receipt number R000049324
Scientific Title Systemic therapy against unresectable hepatocellular carcinoma
Date of disclosure of the study information 2021/02/01
Last modified on 2024/02/04 09:22:03

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Basic information

Public title

Systemic therapy against unresectable hepatocellular carcinoma

Acronym

Systemic therapy against unresectable hepatocellular carcinoma

Scientific Title

Systemic therapy against unresectable hepatocellular carcinoma

Scientific Title:Acronym

Systemic therapy against u-HCC

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation for improving overall survival by systemic therapy in patients with unresectable HCC

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Overall survival after introducing initial systemic treatment

Key secondary outcomes

Anti-tumor responses of systemic treatments (RECIT/ mRECIST), Progression free survival and time to progression of each systemic treatment, adverse events of each systemic treatment, relative changes of hepatic reserve function, nutritional status, tumor markers, physical conditions (muscle volume, muscle strength, body weight), adverse event


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with unresectable liver cancer who received systemic drug treatment

Key exclusion criteria

Patients who disagree with data use

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Hiraoka

Organization

Ehime Prefectural Central Hospital

Division name

Gastroenterology Center

Zip code

7900011

Address

83 Kasuga-cho, Matsuyama, Ehime, Japan

TEL

81899471111

Email

hirage@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Hiraoka

Organization

Ehime Prefectural Central Hospital

Division name

Gastroenterology Center

Zip code

7900011

Address

83 Kasuga-cho, Matsuyama, Ehime, Japan

TEL

81899471111

Homepage URL


Email

hirage@m.ehime-u.ac.jp


Sponsor or person

Institute

RELPEC and HCC48

Institute

Department

Personal name



Funding Source

Organization

none

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

Ehime Prefectural Central Hospital

Address

83 Kasuga-cho, Matsuyama, Ehime, Japan

Tel

81899471111

Email

hirage@m.ehime-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

2021 Year 02 Month 01 Day


Related information

URL releasing protocol

https://www.eph.pref.ehime.jp/epch/patient/asset/30-66.pdf

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35666040/

Number of participants that the trial has enrolled

251

Results

Following adjustment with inverse probability weighting (IPW), Atez/Bev-group showed better PFS (0.5-/1-/1.5-years: 56.6%/31.6%/non-estimable vs. 48.6%/20.4%/11.2%, p < 0.0001) and OS rates (0.5-/1-/1.5-years: 89.6%/67.2%/58.1% vs. 77.8%/66.2%/52.7%, p = 0.002).

Results date posted

2024 Year 02 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

unresectable hepatocellular carcinoma patients treated with systemic chemotherapy

Participant flow

Enrollment of patients excluding those who did not consent to prospective backward-looking studies

Adverse events

none

Outcome measures

PFS, OS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 01 Month 19 Day

Date of IRB

2021 Year 01 Month 22 Day

Anticipated trial start date

2022 Year 02 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation study


Management information

Registered date

2021 Year 02 Month 01 Day

Last modified on

2024 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049324


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name