UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000767 |
|---|---|
| Receipt number | 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 07:53:28 |
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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
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
s-kaneko@umin.ac.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000922
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