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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002863
Receipt No. R000003485
Official scientific title of the study A clinical trial of proton radiotherapy with local immunotherapy for recurrent cases with hepatocellular carcinoma
Date of disclosure of the study information 2016/12/31
Last modified on 2011/07/21

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Basic information
Official scientific title of the study A clinical trial of proton radiotherapy with local immunotherapy for recurrent cases with hepatocellular carcinoma
Title of the study (Brief title) Proton radiotherapy and immunotherapy for hepatic cancer
Region
Japan

Condition
Condition Hepatocellular Carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety of a treatment consisting of proton radiotherapy and local immunotherapy for recurrent cases with hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Prevention of recurrence
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine Device,equipment
Interventions/Control_1 Proton radiotherapy
Tumor immunotherapy by a novel adjuvant
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
80 years-old >
Gender Male and Female
Key inclusion criteria Recurrent cases with locally advanced hepatocellular carcinoma
Life expectency is 6 months or more.
Proton radiotherapy is indicated.
KPS is 60% or more.
Hepatic function is preserved.
Key exclusion criteria Initially diagnosed case
History of having other malignancies
Having autoimmune disorders
HIV positive
Uncontrollable complications such as infections, heart disorders or psychiatric disorders
Administration of anticancer drugs or corticosteroids within 4 months
Pregnant
Tuberculosis, or hyperreaction in DTH test with the advant
Target sample size 10

Research contact person
Name of lead principal investigator Koji Tsuboi
Organization University of Tsukuba
Division name Proton medical research center, Graduate School of Comprehensive Human Sciences
Address 1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL 029-853-7100
Email

Public contact
Name of contact person
Organization University of Tsukuba
Division name Proton Medical Research Center
Address
TEL
Homepage URL
Email

Sponsor
Institute Proton Medical Research Center, University of Tsukuba
Institute
Department

Funding Source
Organization Ibaraki Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

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
2016 Year 12 Month 31 Day

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 12 Month 20 Day
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2009 Year 12 Month 09 Day
Last modified on
2011 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003485

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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