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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034222
Receipt No. R000038966
Scientific Title A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer
Date of disclosure of the study information 2018/09/20
Last modified on 2019/04/01

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Basic information
Public title A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer
Acronym A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer (Ni-HIGH study)
Scientific Title A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer
Scientific Title:Acronym A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer (Ni-HIGH study)
Region
Japan

Condition
Condition HER2 positive advanced or unresectable gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the safety and tolerability of a four-drug combination treatment, i.e. newly combined Nivolumab to Trastuzumab with fluoropyrimidine (S-1 /Capecitabine) plus Oxaliplatin, in Part I of the study. In addition, to exploratory evaluate the efficacy of this combination therapy in Part II.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety (Adverse events, laboratory findings and vital signs)
Key secondary outcomes Tolerability

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 Four-drug combination; Nivolumab, S-1 /Capecitabine, Oxaliplatin and Trastuzumab
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)HER2 positive advanced or unresectable gastric or GEJ cancer that had been confirmed as histological adenocarcinoma.
2)Never been treated by any chemotherapies including for other cancers, chemoradiotherapies, radiation therapies, or hormone therapies.
3)Have at least one evaluable lesion(based on RECIST ver.1.1)
4) Overexpression of HER 2 (IHC 3+, or IHC 2+ and ISH positive [FISH or DISH method]).
5)Age of 20 years and older
6)ECOG Performance Status (PS) is 0 or 1.
7)Functions of main organs (bone marrow, liver, kidney, brain, and blood) are maintained.
8)Have left ventricular ejection rate (LVEF)50% and over measured by echocardiogram or MUGA scan
9)No clinically significant findings in 12-lead electrocardiogram
10)Adequate oral intake.
11)Expected alive more than 3 months.
12)Written informed consent.
Key exclusion criteria Patients who;
1) have complication or history of severe hypersensitive reactions against any antibody products
2)have any active double cancer with less than 5 years of disease-free interval
3)have any active infection diseases
4)have any of heart diseases or conditions within 6 months before registration;
5)are breastfeeding or not ruled out the potency of pregnancy prior to registration
6)not acknowledge for the birth control minimum 5 months for women and 7months for men after the latest last administration
7)have dyspnea at rest due to lung metastasis or cardiovascular diseases
8)have metastatic lesions in brain or meninges
9)have diarrhea
10)have concomitant of autoimmune diseases, or history of chronic or recurrent autoimmune diseases
11)require the administrations of systemic adrenocortical hormone or immunosuppresses, or had treated by them within 28 days before registration.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Kensei
Middle name
Last name Yamaguchi
Organization The Cancer Institute Hospital of JFCR
Division name Department of Gastroenterologyv
Zip code 135-8550
Address 3-8-31 Ariake Koto-ku Tokyo
TEL 03-3520-0111
Email kensei.yamaguchi@jfcr.or.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Takahari
Organization The Cancer Institute Hospital of JFCR
Division name Department of Gastroenterology
Zip code 135-8550
Address 3-8-31 Ariake Koto-ku Tokyo
TEL 03-3520-0111
Homepage URL
Email daisuke.takahari@jfcr.or.jp

Sponsor
Institute The Cancer Institute Hospital of JFCR
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email N/A

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 がん研究会有明病院

国立がん研究センター中央病院

埼玉県立がんセンター

千葉県がんセンター

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 20 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 23 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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