UMIN-CTR Clinical Trial

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
Email	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
Email	toshi27@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045450