UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034990
Receipt number 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 2021/12/01 15:23:04

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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 or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

243

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

2018 Year 11 Month 08 Day

Anticipated trial start date

2018 Year 11 Month 08 Day

Last follow-up date

2020 Year 11 Month 08 Day

Date of closure to data entry

2020 Year 11 Month 08 Day

Date trial data considered complete

2020 Year 11 Month 08 Day

Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 11 Month 25 Day

Last modified on

2021 Year 12 Month 01 Day



Link to view the page

Value
https://center6.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