Clinical trial NCT06767436: A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Official title: A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Gastric Cancer
Keywords: Trastuzumab-deruxtecan
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_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)

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

Detailed 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 criteria: 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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 1 year
measure: analyze the correlation
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: minkyu Jung
state: 서울
Study officials:
affiliation: Yonsei Cencer center
name: minkyu Jung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.