UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034222 |
|---|---|
| Receipt number | 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 | 2024/03/26 11:37:35 |
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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
Gastroenterology Center Gastroenterology medical oncology
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo
TEL
03-3520-0111
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
Gastroenterology Center Gastroenterology medical oncology
Zip code
135-8550
Address
3-8-31 Ariake Koto-ku Tokyo
TEL
03-3520-0111
Homepage URL
daisuke.takahari@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038966
