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Recruiting

NCT Number: NCT06767436

A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer

* 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

Recruiting

Interested in participating?

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • Institutions will be selected through the Gastric Cancer Subcommittee of the Korean Cancer Study Group.
  • This study aims to collect real-world data, targeting patients who started treatment with trastuzumab-deruxtecan from September 2022, for clinical data collection.
  • Among patients treated with trastuzumab-deruxtecan, 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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Progression-free Survival

    Time frame: 1 year

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

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 1 year

    Number of participants with treatment-related adverse events as assessed by CTCAE V5.0

  2. analyze the correlation

    Time frame: 1 year

    To analyze the correlation between HER2 immunohistochemistry (IHC) results and the efficacy of trastuzumab-deruxtecan.

Study contacts

Contact information is provided by the study sponsor or research team.

minkyu Jung

CONTACT

[email protected]

0222278406

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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