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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034990
Receipt No. R000039904
Scientific Title The retrospective analysis of hyperprogressive disease during nivolumab chemotherapy in metastatic gastric cancer
Date of disclosure of the study information 2018/11/30
Last modified on 2018/11/25

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Basic information
Public title The retrospective analysis of hyperprogressive disease during nivolumab chemotherapy in metastatic gastric cancer
Acronym Hyperprogression during nivolumab therapy in gastric cancer
Scientific Title The retrospective analysis of hyperprogressive disease during nivolumab chemotherapy in metastatic gastric cancer
Scientific Title:Acronym Hyperprogression during nivolumab therapy in gastric cancer
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the prevalence and background of hyperprogressive disease treated with nivolumab monotherapy in advanced gastric cancer patients with refractotry to, or intolerant of at least two previous chemotherapy regimens
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To explore the prevalence and background of hyperprogressive disease
Key secondary outcomes To explore the efficacy of nivolumab such as response, progression free survival and overall survival

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 confirmed adenocarcinoma of the stomach or esophago-gastric junction
2) Patents treated with at least two or more lines of previous chemotherapy
3) Treatment with nivolumab monotherapy started between September 22, 2017 and October 31, 2018 in advanced gastric cancer patients with refractotry to, or intolerant of at least two previous chemotherapy regimens (previous chemotherapy must be refractory)
4) Having at least one measurable target lesion defined by CT or MRI
5) CT judged to be refractory to previous chemotherapy can be the baseline data of nivolumab therapy
6) No prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
7) No systemic corticosteroids (10 mg/day or more) or immune-suppressants administered concurrently or within 14 days before registration
Key exclusion criteria Synchronous or metachronous malignancies
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narikazu Boku
Organization National Cancer Center Hospital
Division name Gastrointestinal Medical Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email nboku@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Aoki
Organization National Cancer Center Hospital
Division name Gastrointestinal Medical Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email masaoki@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 恵佑会札幌病院、富山大学附属病院、石川県立中央病院、筑波大学附属病院、埼玉県立がんセンター、慶應義塾大学病院、国立がん研究センター中央病院、虎の門病院、千葉県がんセンター、佐久医療センター、静岡県立静岡がんセンター、愛知県がんセンター中央病院、大阪医科大学附属病院、大阪市立総合医療センター、大阪急性期総合医療センター、大阪国際がんセンター、近畿大学医学部奈良病院、姫路赤十字病院、高知医療センター、九州がんセンター、九州大学病院、JCHO九州病院、宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 30 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 11 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 11 Month 25 Day
Last modified on
2018 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039904

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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