Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.
The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biomarker group | Experimental | 400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets [Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel. |
|
| control group | Active Comparator | Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biomarker screening | Other | immunohistochemistry and in situ hybridization |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | progression free survival | 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
Eastern Cooperative Oncology Group performance status of 0 to 1
Male or female; ≥ 19 years of age
On or progression after 1st line palliative chemotherapy
Subjects with evaluable lesion (using RECIST 1.1 criteria)
Subjects who meet the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sun Young Rha, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System, Yonsei Cancer Center | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37883723 | Derived | Lee CK, Kim HS, Jung M, Kim H, Bae WK, Koo DH, Jeung HC, Park SR, Hwang IG, Zang DY, Lee HW, Park S, Nam CM, Chung HC, Rha SY. Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study. J Clin Oncol. 2024 Jan 20;42(3):348-357. doi: 10.1200/JCO.23.00971. Epub 2023 Oct 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Biomarker-integrated multi-arm with shared standard of care (SOC) control arm
Not provided
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |