UMIN-CTR Clinical Trial

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

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Safety

Key secondary outcomes

Rate of relapse, relapse-free survival, tumor markers, immunological parameters

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Graduate School of Medicine, The University of Tokyo
Seta Clinic Shin-Yokohama

Name of secondary funder(s)

Medinet Co.,Ltd

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2006

Year

07

Month

24

Day

Last modified on

2011

Year

02

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000548