UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062312 |
|---|---|
| Receipt number | R000071303 |
| Scientific Title | A Multicenter Prospective Observational Study Evaluating Effectiveness and Safety of Trastuzumab Deruxtecan in HER2-Positive Gastric Cancer Patients without HER2 Status Immediately Prior to Second-Line Treatment |
| Date of disclosure of the study information | 2026/09/21 |
| Last modified on | 2026/07/23 11:06:56 |
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Basic information
Public title
A Multicenter Prospective Observational Study Evaluating Effectiveness and Safety of Trastuzumab Deruxtecan in HER2-Positive Gastric Cancer Patients without HER2 Status Immediately Prior to Second-Line Treatment
Acronym
EN-ABLE study
Scientific Title
A Multicenter Prospective Observational Study Evaluating Effectiveness and Safety of Trastuzumab Deruxtecan in HER2-Positive Gastric Cancer Patients without HER2 Status Immediately Prior to Second-Line Treatment
Scientific Title:Acronym
EN-ABLE study
Region
| Japan |
Condition
Condition
HER2-positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of T-DXd as second-line treatment in real-world patients with initially HER2-positive gastric cancer whose HER2 status has not been reassessed immediately prior to second-line treatment initiation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate (ORR)
Key secondary outcomes
･Overall survival (OS)
･Progression-free survival (PFS)
･Time to treatment failure (TTF)
･Disease control rate (DCR)
･Duration of response (DOR)
･Time to response (TTR)
･Early tumor shrinkage (ETS)
･Depth of response (DpR)
･Adverse events
-Adverse events of Grade >= 3
-Interstitial lung disease (ILD) of any grade
-Adverse events resulting in dose reduction and interruption of T-DXd
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with unresectable advanced or recurrent gastric cancer (gastric adenocarcinoma or gastroesophageal junction adenocarcinoma) that
has progressed after prior chemotherapy
2) Patients diagnosed with HER2-positive gastric cancer prior to first-line therapy based on pathological assessment (IHC 3+ or IHC 2+ and ISH-positive)
3) Patients with a history of receiving first-line chemotherapy including trastuzumab
4) Patients planned to receive T-DXd as second-line therapy
5) Patients who have not undergone HER2 IHC testing between the initiation of trastuzumab in first-line therapy and the initiation of T-DXd in second-line therapy, or patients whose IHC test results were uninterpretable
6) Patients with measurable lesions
7) Patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1
8) Patients who have provided written informed consent
Key exclusion criteria
1) Patients with a history of hypersensitivity to T-DXd or its components
2) Patients with prior treatment with T-DXd
3) Patients with active multiple primary cancers that are considered by the investigator to potentially affect the evaluation of T-DXd
4) Patients with a history of perioperative treatment who initiated trastuzumab-containing chemotherapy within 6 months after the completion of the perioperative Treatment
5) Patients deemed ineligible for this study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumaicho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-741-2111
kanda.mitsuro.v5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ota |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5804-5045
Homepage URL
prj-en-able@eps.co.jp
Sponsor or person
Institute
NAGOYA UNIVERSITY HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
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
Nihonbashi Sakura Clinic Research Ethics Committee
Address
c-irb_ug@neues.co.jp
Tel
03-6777-1480
c-irb_ug@neues.co.jp
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
名古屋大学医学部附属病院（愛知県）、愛知県がんセンター（愛知県）、他 58施設
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071303
