UMIN-CTR Clinical Trial

Basic information
Public title	Study on safety and efficacy of mFOLFOX6 after exposure to an immune checkpoint inhibitor in advanced gastric cancer
Acronym	Study on safety and efficacy of mFOLFOX6 after exposure to an immune checkpoint inhibitor in advanced gastric cancer
Scientific Title	A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer
Scientific Title:Acronym	A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Incidence of adverse events Disease control rate 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	Medicine
Interventions/Control_1	The treatment consisted in the administration of 85 mg/m2 oxaliplatin and 200 mg/m2 LV by a 2-h intravenous infusion, followed by the administration of 400 mg/m2 bolus 5-FU and 2400 mg/m2 5-FU by a 46-h continuous infusion. The treatment was repeated every 2 weeks.
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) Histologically proven gastric adenocarcinoma 2) Age above 20 years old 3) ECOG performance status of 0 or 1 4) Adequate organ function 1. WBC:>=3,000/mm3,<12,000/mm3 2. Neutrophil:>=1,500/mm3 3. Platelet:>=100,000/mm3 4. Hemoglobin:>=9.0g/dL 5. AST(GOT)/ALT(GPT):<=100 IU/L 6. Total bilirubin:<=2.0mg/dL 5) Written informed consent from patient 6)Patients undergoing exposure to immune checkpoint inhibitors in advanced gastric cancer
Key exclusion criteria	1) Severe complications 2) With active infection 3) Past history of severe hypersensitivity to drugs 4) Pregnant women, or women with the possibility of the pregnancy, Men who want let to pregnancy 5) Patients judged inappropriate for the study by the physicians
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Dai Middle name Last name Manaka
Organization	Kyoto Katsura Hospital
Division name	Department of Surgery, Gastro-Intestinal Center
Zip code	615-8256
Address	17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL	075-391-5811
Email	d_manaka@katsura.com

Public contact
1st name of contact person	1st name Sayuri Middle name Last name Konishi
Organization	Kyoto Katsura Hospital
Division name	Department of Surgery, Gastro-Intestinal Center
Zip code	615-8256
Address	Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL	075-391-5811
Homepage URL
Email	sayurik0713@gmail.com

Sponsor
Institute	Kyoto Katsura Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto Katsura Hospital
Address	Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
Tel	075-391-5811
Email	chiken@katsura.com

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	2019 Year 03 Month 11 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	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 08 Month 24 Day
Anticipated trial start date	2018 Year 08 Month 24 Day
Last follow-up date	2023 Year 12 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	2019 Year 03 Month 11 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041172