UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038178 |
|---|---|
| Receipt number | R000043522 |
| Scientific Title | Cryoablation followed by immune-checkpoint inhibitor treatment for III/IV lung cancer or metastatic lung cancer where standard treatment is ineffective |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2019/10/02 17:59:49 |
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Basic information
Public title
Cryoablation followed by immune-checkpoint inhibitor treatment for III/IV lung cancer or metastatic lung cancer where standard treatment is ineffective
Acronym
Cryoablation followed by immune-checkpoint inhibitor treatment for lung cancer
Scientific Title
Cryoablation followed by immune-checkpoint inhibitor treatment for III/IV lung cancer or metastatic lung cancer where standard treatment is ineffective
Scientific Title:Acronym
Cryoablation followed by immune-checkpoint inhibitor treatment for lung cancer
Region
| Japan |
Condition
Condition
III or IV stage lung cancer or metastatic cancer where standard therapy is ineffective
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
After cryoablation for lung cancer, vaccine effect is sometimes seen caused by necrotic tumor. Therefore, combination with cryoablation and immune-checkpoint inhibitor is expected to increase its drug efficacy, whichi is the primary purpose of the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
For patients with III/IV stage lung cancer or multiple metastatic lung cancer who are refractory to standard therapy, the main lung tumor is treated by cryoablation followed by starting immune checkpoint inhibitor around 4 weeks later with 4 cycles at minimum. The efficacy of the drug is investigated especially whether it is superior over the effective rate reported so far.
Key secondary outcomes
To investigate whether the cryoablation for lung cancer increase the interstitial pneumonia, which is one of side effects of immune checkpoint inhibitor.
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
| Maneuver |
Interventions/Control_1
For Stage III/IV lung cancer or multiple metastatic lung cancer, the main tumor is treated by cryoablation, followed by statring immune-checkpoint inhibitor around 4 weeks later. After 4 cycles at minimum, the size of tumor which is not treated by cryoablation is examined.
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
| Not applicable |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. III/IV stage lung cancer or multiple emtastatic lung cancer.
2. For metastatic lung cancer other than primary lung cancer, the tumors show microsatelite instability(MSI)-high.
3. Even having another metastatic tumors, the life extension is expected if the main tumor is treated by cryoablation.
4. Informed consent with risk and long-term forecast.
Key exclusion criteria
1. Patients having obvious interstitial pneumia.
2. Tumors located where the cryoprobe insertion is not available.
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
TEL
0471-45-1111
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
617 Shikoda, Kashiwa City, Chiba
TEL
0471-45-1111
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital, Department of Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
Kashiwa Kousei General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kashiwa Kousei General Hospital
Address
617 Shikoda, Kashiwa City, Chiba
Tel
0471-45-1111
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）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 04 | 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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2029 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2029 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2029 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043522
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
