UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039854 |
|---|---|
| Receipt number | R000045450 |
| Scientific Title | Phase 1/2 clinical trial of the intratumoral administration of oncolytic virus for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/01/06 21:23:31 |
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Basic information
Public title
Phase 1/2 clinical trial of the intratumoral administration of oncolytic virus for unresectable pancreatic cancer
Acronym
Intratumoral administration of oncolytic virus for unresectable pancreatic cancer
Scientific Title
Phase 1/2 clinical trial of the intratumoral administration of oncolytic virus for unresectable pancreatic cancer
Scientific Title:Acronym
Intratumoral administration of oncolytic virus for unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The assessment of the safety and efficacy of the intratumoral administration of Surv.m-CRA-1 for patients with unresectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event, response rate
Key secondary outcomes
Serum level of adenovirus, adenovirus excretion, antibody level of adenovirus, cytokine levels, rate of tumor size reduction, histological assessment, progression-free survival, overall survival
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
| Gene |
Interventions/Control_1
Intratumoral administration of Surv.m-CRA-1
Frequency of administration: once a week, three times in total
Dose: 1xE+11 viral particles
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with pancreatic tumors must meet the following eligibility criteria:
1) Diagnosed histologically with pancreatic ductal carcinoma.
2) Diagnosed with unresectable pancreatic cancer because of metastasis and/or vascular invasion.
3) Primary standard treatment for unresectable pancreatic cancer failed.
If a patient who received radiation or chemoradiation therapy for locally advanced pancreatic cancer is judged to have failed the primary treatment due to metastasis without progression of pancreatic cancer or drug-induced adverse events, the period after radiation must be at least one month.
4) The long and short axes and height of the pancreatic lesion can be measured by computed tomography, and the investigational agent can be administered to the lesion.
5) >= 20 years old.
6) ECOG performance status (PS) is 0-2.
7) The overall survival is expected to exceed three months.
8) Main organ functions are maintained (according to the latest blood test performed within two weeks before registration):
Hb >= 7 g/dL
WBC >= 2,000/microL
Plt >= 50,000/microL
AST (GOT) <= 100 IU/L
ALT (GPT) <= 100 IU/L
T-bil <= 3.0 mg/dL
Cr <= 2.0 mg/dL
9) Agrees to not become pregnant.
10) Gives their written consent to participate in the clinical trial.
Key exclusion criteria
1) Patients with the following complications: Severe heart disease, severe respiratory disease, severe digestive disease, severe liver disease, uncontrolled diabetes, and infection requiring continuous treatment
2) Patients with a history of penicillin or allergy to pigs or cattle (including milk).
3) Patients with a disease that requires the administration of systemic immunosuppressants or steroids.
4) For patients judged to have failed the primary therapy of radiation or chemoradiation, the interval after the therapy is <= 1 month (patients are still eligible if the reason for primary therapy failure is progression of pancreatic cancer).
5) Patients with other currently active cancers (patients are still eligible if the other cancers are basal cell carcinoma, carcinoma in situ, superficial bladder cancer, or malignancies without metastasis or recurrence for more than five years and have been treated appropriately)
6) Patients with an uncontrollable fever or pain due to the tumor.
7) Patients with a history of gastroduodenal surgery or gastroduodenal stricture.
8) Patients who are pregnant, breast-feeding, or have a positive pregnancy test within one year after menopause.
9) Patients who received any other unapproved drug within four weeks before giving their consent.
10) Patients deemed inappropriate to include in the trial by the investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Ido |
Organization
Kagoshima University
Division name
Digestive and Lifestyle Diseases
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5326
ido-akio@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Futagawa |
Organization
Kagoshima University hospital
Division name
Division of Clinical Trial, Clinical Research Management Center
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5553
Homepage URL
toshi27@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Trial, Clinical Research Management Center, Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-5553
toshi27@m3.kufm.kagoshima-u.ac.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
鹿児島大学病院(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2020 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045450
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| Registered date | File name |
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| Registered date | File name |
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