UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I Study of Intratumoral Administration of HF10, Oncolytic Herpes Simplex Virus Type 1, in Patients with Advanced Unresectable Pancreatic Cancer
Title of the study (Brief title)	Clinical Study using HF10 against Advanced Unresectable Pancreatic Cancer
Region	Japan

Condition
Condition	Advanced Unresectable Pancreatic Cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of HF10 in combination with conventional chemotherapy (Gemcitabine + Erlotinib).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Safety and tolerability
Key secondary outcomes	anti-tumor activity Immune response Viral replication

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Drug : HF10 Dose/cohort : Cohort1 : 1x10(6) pfu/day Cohort2 : 3x10(6) pfu/day Cohort3 : 1x10(7) pfu/day Method : 1 injection/2 weeks. Total 4 injections in combination with Erlotinib and Gemcitabine
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	-Non-resectable locally advanced pancreatic cancer. -Tumor lesion accessible by EUS. -No systemic metastasis. (PL invasion to be included in the locally advanced cancer.)
Key exclusion criteria	Patient with: -Ascites. pleural infusion. -Infectious disease. -Any other cancer. -Brain metastasis. -hypersensitivity to live-virus vaccine. Pregnant or breast feeding patient.
Target sample size	9

Research contact person
Name of lead principal investigator	Hideki Kasuya
Organization	Nagoya University School of Medicine
Division name	Office of International affair
Address	65Tusrumai-cho, Showa-ku Nagoya Japan
TEL	81-52-744-2507
Email

Public contact
Name of contact person
Organization	Nagoya University School of Medicine
Division name	Office of International Affair
Address
TEL
Homepage URL
Email	kasuya@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Takara Bio. Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 03 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 08 Day
Anticipated trial start date	2013 Year 04 Month 30 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 02 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000010559