UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000451
Receipt No. R000000548
Scientific Title Clinical study of intratumoral dendritic cell injection after radiofrequency ablation therapy in hepatitis C virus-related hepatocellular carcinoma patients
Date of disclosure of the study information 2006/07/24
Last modified on 2011/02/08

* 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 Clinical study of intratumoral dendritic cell injection after radiofrequency ablation therapy in hepatitis C virus-related hepatocellular carcinoma patients
Acronym Combination of RFA and intratumoral DC injection for the treatment of HCC
Scientific Title Clinical study of intratumoral dendritic cell injection after radiofrequency ablation therapy in hepatitis C virus-related hepatocellular carcinoma patients
Scientific Title:Acronym Combination of RFA and intratumoral DC injection for the treatment of HCC
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of intratumoral DC injection after radiofrequency ablation therapy for the treatment of hepatitis C virus (HCV)-related hepatocellular carcinoma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Key secondary outcomes Rate of relapse, relapse-free survival, tumor markers, immunological parameters

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
Vaccine Maneuver
Interventions/Control_1 Intratumoral DC injection (Once a week, 4times)
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 HCV-related hepatocellular carcinoma patients whom principle investigator or co-investigator judged to be completely cured by radiofrequency ablation therapy, and who meet the following conditions:
- 20 years or more
- Performance status 0-1
- No serious abnormality in bone marrow, liver and/or renal functions
Key exclusion criteria Patients who have: uncontrolled infections, active autoimmune diseases, serious cardiac disease and other cancers; who have received continuous systemic steroids; who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminori Moriyasu/Kazuhiro Kakimi
Organization Tokyo Medical University/The University of Tokyo
Division name Department of Gastroenterology and Hepatology/Department of Immunotherapeutics (medinet)
Zip code
Address 6-7-1, Nishi-Shinjyuku, Sinnjyuku-ku, Tokyo, Japan/7-3-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1, Nishi-Shinjyuku, Sinnjyuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Graduate School of Medicine, The University of Tokyo
Seta Clinic Shin-Yokohama
Name of secondary funder(s) Medinet Co.,Ltd

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Two patients with hepatocellular carcinoma (HCC) received intratumoral injection of dendritic cells(DC) after radiofrequency ablation therapy (RFA). One patient developed severe interstitial pneumonitis after DC injection. The patient promptly received steroid pulse therapy and recovered well from this severe adverse event.  Because an association between interstitial pneumonitis and DC injection could not be ruled out, the study was stopped temporarily and new study was conducted (UMIN000000971) to examine the safety of DC injection in advanced HCC rather than primary or early stage HCC patients. DCs were injected into the tumor after RFA in three advanced HCC patients.  The intratumoral DC injections were safe and feasible and no severe adverse event was observed in these three patients.  These results indicated the interstitial pneumonitis was likely due to the patient's specific reaction in that particular patient.
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 Completed
Date of protocol fixation
2006 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 07 Month 24 Day
Last modified on
2011 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.