Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2016-01-01
2024-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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biomarker group
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.
biomarker screening
immunohistochemistry and in situ hybridization
control group
Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.
biomarker screening
immunohistochemistry and in situ hybridization
Interventions
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biomarker screening
immunohistochemistry and in situ hybridization
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group performance status of 0 to 1
3. Male or female; ≥ 19 years of age
4. On or progression after 1st line palliative chemotherapy
5. Subjects with evaluable lesion (using RECIST 1.1 criteria)
6. Subjects who meet the following criteria:
* Absolute neutrophil count ≥ 1000 /µL
* Platelet count ≥ 75,000/ µL
* Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
* aspartate aminotransferase and alanine transaminase 3 x upper limit of normal
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Sun Young Rha
professor
Principal Investigators
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Sun Young Rha, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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4-2015-0616
Identifier Type: -
Identifier Source: org_study_id