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

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

Recruiting
19 years and older
All
Phase N/A

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Overview

  • 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

Description

  • 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)

Eligibility

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.

Study details
    Advanced Gastric Cancer

NCT06767436

Yonsei University

17 January 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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