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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000767
Receipt No. R000000922
Scientific Title Phase-I/IIa study of radiofrequency ablation combined with in situ application of immunoadjuvant, Cal-TUMP
Date of disclosure of the study information 2010/04/01
Last modified on 2013/04/08

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Basic information
Public title Phase-I/IIa study of radiofrequency ablation combined with in situ application of immunoadjuvant, Cal-TUMP
Acronym R-Cal-TUMP
Scientific Title Phase-I/IIa study of radiofrequency ablation combined with in situ application of immunoadjuvant, Cal-TUMP
Scientific Title:Acronym R-Cal-TUMP
Region
Japan

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

Objectives
Narrative objectives1 Safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patient selection
Hepatocellular carcinoma patients with multiple nodules in liver or with distant metastasis, which are inadequate to curative treatment and refractory for chemotherapy using antitumor drugs (more than 2 cycles).The patients with preserved liver function (liver damage A or B in 4th criteria Liver Cancer Study Group of Japan) and more than 2 months estimated survival period. The patients should be able to performance radiofrequency ablation therapy. (following: the patients called with RFA+ISAIA cases)
Inclusion criteria
1. Histologically- or radiologically- proven hepatocellular carcinoma with multiple intrahepatic nodules or distant metastasis
2. At lease single nodules which measurable by imaging study
3. Not adequate to curative treatment
4. Refractory for chemotherapy using antitumor drugs (more than 2 cycles)(RECIST criteria SD,PD)
5. No vascular invasion (portal vein, bile duct hepatic vein)
6. More than 2 months estimated survival period
7. Possible to radiofrequency ablation therapy
8. Preserved liver function (liver damage A or B in 4th criteria Liver Cancer Study Group of Japan)
9. Preserved bone marrow function after chemotherapy (WBC >3000/uL, Lymphocyte >1000/uL, Hb >8.5g/dL, Platelet>50000/uL at the point of more than 4 weeks after chemotherapy)
10. Normal renal function (serum Cr less than 1.5 mg/dL)
11. Karnofsky Perfomance Scale (KPS) more than 60% or ECOG Performance status 0 or 1
12. More than 18 years old, less than 90 years old
13. Informed about the cancer and the severity, get adequate informed consent
14. Possible to treatment and follow up in our hospital

10. Normal renal function (serum Cr less than 1.5 mg/dL)
11. Karnofsky Perfomance Scale (KPS) more than 60% or ECOG Performance status 0 or 1
12. More than 18 years old, less than 90 years old
13. Informed about the cancer and the severity, get adequate informed consent
14. Possible to treatment and follow up in our hospital
Key exclusion criteria Exclusion criteria
1) Past history of other caner except hepatocellular carcinoma in recent 5 year, or present affecting cancer
2) Past history of autoimmune disease or present affecting autoimmune disease
3) Infected HIV
4) Technically difficult main tumor for radiofrequency ablation
5) Difficult for this treatment because of hematological disease or bleeding tendency
6) Uncontrolled diseases such as sever infectious disease, severe cardiac disease and psychological diseases
7) (1) Systemic administration of anti-cancer drugs or steroid, (2) Radiological or biological treatment which may affect to systemic condition, within 4 weeks before this treatment
8) Pregnant or nursing woman or person who has the possibility of pregnancy and plan to pregnant
9)Affecting tuberculosis, or more than 2 cm in diameter induration reaction positive after skin reaction test using immune adjuvant specially made in our hospital
10) inadequate cases by principle doctor including uncertainty to adherent to treatment protocol
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa university
Division name Graduate school of medicine
Zip code
Address Takara-machi, Kanazawa, Ishikawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa university
Division name University hospital
Zip code
Address
TEL
Homepage URL
Email s-kaneko@umin.ac.jp

Sponsor
Institute Kanazawa university
Institute
Department

Funding Source
Organization Kanazawa university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kasumigaura Hospital Tokyo Medical University
Name of secondary funder(s) Cell Medicine 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
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2007 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2011 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
2007 Year 07 Month 10 Day
Last modified on
2013 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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