Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
trastuzumab, bevacizumab with paclitaxel (triple combination)
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- HER2-positive advanced gastric cancer
Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratorytests. (SISH positivity is defined as the ratio of the HER2 gene copy number tothe CEP17 signal ≥ 2.0)
or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)
Patients who have progressed in response to one systemic anticancer therapy foradvanced gastric cancer
Patients who are willing and able to write a written consent form for this trial.
Patients aged 19 years or older at the time of signing the subject consent form.
Patients with measurable or evaluable lesions according to RECIST 1.1.
ECOG activity status 0, 1 or 2
as patients with adequate organ function
Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory testswithin 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN
Echocardiogram EF ≥55% or MUGA scan ≥50%
Exclusion
Exclusion Criteria:
Patients who have received chemotherapy, radiation therapy, immunotherapy ortargeted therapy for gastric cancer within the past 2 weeks.
Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months
Patients who have experienced an arteriovascular embolism event, including but notlimited to myocardial infarction, transient ischemic attack, cerebrovasculardisorder, or unstable angina within 6 months
Ongoing or active infection, symptomatic congestive heart failure, unstable angina,symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic orhemorrhagic disorders, or any other serious medical disorder not controlled in theinvestigator's judgment patient with
Patients with a history of gastrointestinal perforation or fistula within 6 months.
Concomitant diagnosis of cancer in another site or history of active malignant tumorwithin the past 3 years
- Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervicalcancer
Study Design
Study Description
Connect with a study center
Kangbuk Samsung Hospital
Seoul, 110-746
Korea, Republic ofActive - Recruiting

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