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Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer.

Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer. - HGCSG 2303

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055133
Enrollment
60
Registered
2024-08-02
Start date
2024-06-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable or advanced recurrent HER2-positive gastric cancer or cardioesophageal cancer.

Interventions

None listed

Sponsors

Hokkaido university hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have failed prior trastuzumab-based chemotherapy for unresectable advanced or recurrent gastric cancer. 2. Patients who have undergone (or will undergo) tissue collection (biopsy or surgery) and HER2 testing after completion of trastuzumab-containing chemotherapy. 3. Over 20 years of age. 4. Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) 0-2. 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with active multiple cancers. 2. Those who had drainage for fluid retention (pleural, ascites, pericardial fluid, etc.) within 2 weeks prior to enrollment. 3. Patients with pulmonary fibrosis or interstitial pneumonia. 4. Those with serious complications. 5. Those with active infectious diseases. 6. Those with active viral hepatitis. 7. Poorly controlled diabetes mellitus patients. 8. Those with serious psychiatric or central nervous system disorders. 9. Those with severely abnormal electrocardiogram or with clinically problematic cardiac condition. 10. Other individuals who are judged by the research director or co-researcher to be inappropriate as research subjects.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Progression free survival, Disease control rate, Overall survival, Safety, HER2 Status

Countries

Japan

Contacts

Public ContactKoichi Ishida

Hokkaido University Hospital Department of Gastroenterology and Hepatology

ishida.koichi.e3@elms.hokudai.ac.jp0117161161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026