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This protocol is a screening protocol only. No drug intervention study will be included in this protocol. However, based on the molecular profiling, patients may be eligible for targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1 inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of clinical trials depending on the availability.
To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry. This protocol is a screening protocol and informed consent form will be obtained again according to the biomarker profiled on this protocol if eligible. Informed consent will be obtained from patients with gastric adenocarcinoma and analysis of fresh tissue or archival FFPE at Samsung Medical Center will be performed. Patients who have prior to or completed or during the first-line chemotherapy (fluoropyramidine/platinum-based) will be eligible for screening.
After the analysis, pathologic and molecular biologic verification process about validity of the result will proceed. The biopsies will be performed before or after or during first-line treatment for molecular analysis. The patients who are screened through this protocol will undergo baseline biopsy before or after or during first-line therapy.
Study Objectives
Planned subgroup analyses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | molecular profiling, patient derived cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular profiling | Other | molecular profiling, patient derived cells, fresh or FFPE |
|
| Measure | Description | Time Frame |
|---|---|---|
| molecular screening ( biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry) | To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry. | from data of start of targeted tretment oriented by molecular screening until the date of first progression or date of death form any cause, whichever came first, assessed up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | OS (biomarker negative vs biomarker postivie metastatic GC patients) | 1years |
| PFS | PFS (biomarker negative vs biomarker postivie metastatic GC patients) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeeyun Lee, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical center | Seoul | 135-710 | South Korea | |||
| Samsung Medical Center |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 1years |
| OS/PFS | OS/PFS (EBV negative vs positive metastatic GC patients) | 1years |
| Seoul |
| South Korea |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |