UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Title of the study (Brief title)	Hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Region	Japan

Condition
Condition	Resectable pancreatic cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In pancreatic cancer, we examine the safety and anti-tumor effect of 3-oxygelmillpropionic acid polymer (a trade name: Seroshion) .
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	efficacy

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	Medicine
Interventions/Control_1	The dose of Seroshion is 1 capsule (10mg) /time after each meal (3 times/day,30mg/day). The administration period is six months.
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	(1) The case who was diagnosed histologically pancreatic cancer (2)The case who underwent R0 resection for pancreatic cancer.(3)The age is over 20 years old.(4)PS (ECOG) is 0 or 1. (5)Within 14 days before,major organ function is held by clinical examination.1)WBC is above 3,000 / mm3 and below 12,000/mm3. 2)Plt is above 100,000/mm3, 3)Hb is above 8.0g / dL, 4)AST (GOT) is below 100IU / L, and ALT (GPT)is below 100IU/L. 5)T-bil is below 2.0mg/dL. 6)Cr is below 1.2mg/dL 7)Ccr is above 50mL/min. (6)The patients can eat orally. (7)The patients who can start treatment within 4 to 12 weeks after surgery. (8)The patients who obtained the written consent before performing the various procedures for the test. Patients who can understand and are willing to sign the contents of the consent document.
Key exclusion criteria	(1)Patients who could not resected curatively.(2)Patients with active double cancer. (3)Patients with serious drug hypersensitivity or with a history of drug allergy.(4)Patients with serious complications.(5)Patients with jaundice,cirrhosis or with suspected cirrhosis of the liver.(6)There is a history of chronic hepatitis B, and in the present study drug has already been ingested.(7)Patients with active infection.(8)Women who have a possibility of or in the pregnancy,who hope to become pregnant,or who are breast-feeding. Men who wish to become pregnant partner.(9)Patients with severe mental disorder.(10)Other patients whom the physician decided to be unsuitable for safely carrying out the present study.
Target sample size	10

Research contact person
Name of lead principal investigator	Hidetoshi Eguchi
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Hidetoshi Eguchi
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Homepage URL
Email	heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	National Institute of Public Health
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 05 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 13 Day
Anticipated trial start date	2015 Year 10 Month 14 Day
Last follow-up date
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	2017 Year 05 Month 22 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031431