UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059855 |
|---|---|
| Receipt number | R000068406 |
| Scientific Title | Combination with dendritic cell vaccine therapy and cryoablation for lung cancers |
| Date of disclosure of the study information | 2025/11/22 |
| Last modified on | 2025/11/22 13:42:31 |
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Basic information
Public title
Combination with dendritic cell vaccine therapy and cryoablation for lung cancers
Acronym
Combination with dendritic cell vaccine therapy and cryoablation for lung cancers
Scientific Title
Combination with dendritic cell vaccine therapy and cryoablation for lung cancers
Scientific Title:Acronym
Combination with dendritic cell vaccine therapy and cryoablation for lung cancers
Region
| Japan |
Condition
Condition
Malignant pulmonary tumor
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For malignant lung tumors with multiple metastases, combination with cryoablation for the largest lung tumors and dendritic cell vaccine therapy is examined for additive or synergy effect for the metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Shrinking effect of metastases without cryoablation and survival time.
Key secondary outcomes
Complication of the combination therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Treatment period is 3 months. Dendritic cells are extracted from the patient, which are incubated with cancer antigen or cytokine to strengthen the immunity. Every 2-3 weeks, dendritic cells are injected subcutaneously at the Precision Clinic, which is approved from the Ministry of Welfare. The day after the 1st administration of dendritic cells, the cryoablation is conducted for the largest pulmonary tumor. After the cryoablation, the dendritic cells are injected subcutaneously every 2-3 times for 6 times.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient has multiple metastases, of which one exists in lung and its size is over 2 cm. The patient has been already treated by chemotherapy, of which effect is stable or progressive disease. The patient performance status is lower than 2.
Key exclusion criteria
Myelodysplastic syndromes.
Severe clinical symptoms.
Psychiatric disorders.
Immunocompromised disease.
Pregnant or breast-feeding woman.
Unsuitable status judged by doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
Kashiwa Kousei General Hospital
Division name
Thoracic Surgery
Zip code
277-8551
Address
617 Shikoda, Kashiwa-city, Chiba prefecture
TEL
0471451111
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nomori |
Organization
Kashiwa Kousei General Hospital
Division name
Thoracic Surgery
Zip code
277-8551
Address
Shikoda 617, Kashiwa-city, Chiba prefecture
TEL
0471451111
Homepage URL
https://www.kashiwakousei.or.jp/medical/klokyukigeka/
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital
Institute
Department
Personal name
Hiroaki Nomori, MD
Funding Source
Organization
Kashiwa Kousi General Hospital, Precision Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kashiwa Kousei General Hospital, Ethics Committee
Address
Shikoda 617, Kashiwa-city, Chiba prefecture
Tel
0471451111
hnomori@qk9.so-net.ne.jp
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
柏厚生総合病院（千葉県）、プレシジョンクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2035 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068406
