NCT06767436

Brief Summary

  • Institutions will be selected
  • This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection
  • Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024
  • For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration)
  • Efficacy evaluation

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 26, 2024

Last Update Submit

January 5, 2025

Conditions

Advanced Gastric Cancer

Keywords

Trastuzumab-deruxtecan

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    To present real-world clinical outcomes of trastuzumab-deruxtecan as third-line or later treatment in HER2-positive gastric cancer.

    1 year

Secondary Outcomes (2)

  • Number of participants with treatment-related adverse events

    1 year

  • analyze the correlation

    1 year

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Institutions will be selected * targeting patients who started treatment with Enhertu from September 2022, for clinical data collection * Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024. * For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration), data will be collected with consent until March 31, 2027. * Efficacy evaluation will include overall survival (OS), progression-free survival (PFS), and tumor response rate (TRR)

You may qualify if:

  • Patients aged 19 years or older.
  • Patients with pathologically confirmed metastatic, recurrent, or unresectable gastric/gastroesophageal adenocarcinoma.
  • Patients whose tumor tissue shows HER2 immunohistochemistry (IHC) results of 3+ or 2+ with in-situ hybridization (ISH) positivity.
  • Patients who received Trastuzumab Deruxtecan as third-line or later treatment.

You may not qualify if:

  • Patients with HER2-negative gastric cancer.
  • Patients who did not provide consent to participate in the study.
  • Patients who received Trastuzumab Deruxtecan as first-line or second-line treatment as part of a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

minkyu Jung

Seoul, Seoul, 03722, South Korea

RECRUITING

Related Publications (2)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND

  • Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.

    PMID: 32469182BACKGROUND

Study Officials

  • minkyu Jung

    Yonsei Cencer center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

minkyu Jung

CONTACT

0222278406minkjung@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 9, 2025

Study Start

November 5, 2024

Primary Completion

November 4, 2025

Study Completion

November 4, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

KR(1)