臨床研究等提出・公開システム

Date of registration	Nov. 10, 2020
Last modified on	Nov. 10, 2020
Trial ID	jRCT1030200192

Scientific Title	Translational research for a Phase I study of tocilizumab plus gemcitabine/nab-paclitaxel in patient with gemcitabine/nab-paclitaxel-refractory metastatic pancreatic cancer
Public Title	TCZ+GN TR

Contact for Scientific Queries	Name	Mitsunaga Shuichi
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha Kashiwa Chiba
	Telephone	+81-471331111
	E-mail	smitsuna@east.ncc.go.jp
Contact for Public Queries	Name	Mitsunaga Shucihi
	Affiliation	National Cancer Center Hospital East
	Address	6-5-1 Kashiwanoha Kashiwa Chiba
	Telephone	+81-4-7133-1111
	E-mail	smitsuna@east.ncc.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 04, 2019
Actual date of first enrollment		May. 29, 2019
Target sample size		10
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1. Partipants for a Phase I study of tocilizumab plus gemcitabine/nab-paclitaxel in patient with gemcitabine/nab-paclitaxel-refractory metastatic pancreatic cancer 2. Tumor tissue from the patient was available 3. Written informed consent for participation in the study is obtained at the discretion of the patient.
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic cancer
Health Condition(s) Keyword		Pancreatic ductal adenocarcinoma
Health Condition(s) Code		C535836
Primary Outcome(s)		1. Suppresion of IL-6 signaling using a decrease of intratumoral pSTAT3 expression 2. Suppresion of desmoplasia using a decrease of intratumoral alppha-SMA expression 3. Change of tumor-infiltrating lymphocyte

Primary Sponsor	Chugai pharma

Source of Monetary Support / Secondary Sponsor	Chugai pharma
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	6-5-1 Kashiwanoha Kashiwa, Chiba
Telephone	+81-4-7133-1111
E-Mail	ncche-irb@east.ncc.go.jp
Approval Status	Approval
Date of approval	Mar. 22, 2019

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none