UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029991
Receipt number R000034249
Scientific Title A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma
Date of disclosure of the study information 2017/11/20
Last modified on 2023/11/20 17:26:48

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Basic information

Public title

A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma

Acronym

A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma

Scientific Title

A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma

Scientific Title:Acronym

A phase I study of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma

Region

Japan


Condition

Condition

hepatocellular carcinoma

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Surgery in general
Hepato-biliary-pancreatic surgery Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this study is to evaluate the clinical efficacy and safety of combination adjuvant immunotherapy for patients with resectable hepatocellular carcinoma

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

safety

Key secondary outcomes

1)specific CTL response in PBMC
2)specific CTL response in the tumor
3)relapse-free survival
4)overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Vaccine

Interventions/Control_1

combination immunotherapy

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

resectable HCC

Key exclusion criteria

Uncontroled general complication.
etc

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Nagano

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Gastroenterological, Breast and Endocrine Surgery

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Email

geka2dm@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Shoichi
Middle name
Last name Hazama

Organization

Yamaguchi University School of Medicine

Division name

Department of Translational Research and Developmental Therapeutics against Cancer

Zip code

755-8505

Address

1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-3186

Homepage URL

http://www.yamadai-gesurgery.jp/

Email

hazama@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

CYTLIMIC Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yamaguchi University Hospital, Clinical Research Center

Address

1-1-1 Minamikogushi

Tel

81836222428

Email

me223@yamaguchi-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 11 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/hepr.13900

Number of participants that the trial has enrolled

20

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

No longer recruiting

Date of protocol fixation

2017 Year 11 Month 15 Day

Date of IRB

2017 Year 12 Month 20 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 15 Day

Last modified on

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name