Actively Recruiting
Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
Led by Kangbuk Samsung Hospital · Updated on 2024-11-26
47
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.
CONDITIONS
Official Title
Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HER2-positive advanced gastric cancer confirmed by laboratory tests
- Disease progression after one systemic anticancer therapy for advanced gastric cancer
- Willingness and ability to provide written informed consent
- Age 19 years or older at the time of consent
- Presence of measurable or evaluable lesions according to RECIST 1.1 criteria
- ECOG performance status of 0, 1, or 2
- Adequate organ function including neutrophil count 1.0 x 10^9/L, platelet count 100 x 10^9/L, hemoglobin 9 g/dL, serum creatinine 1.5 x upper limit of normal, total bilirubin 3.0 mg/dL, AST/ALT 5 x upper limit of normal
- Cardiac function with ejection fraction 5% by echocardiogram or 50% by MUGA scan
You will not qualify if you...
- Receipt of chemotherapy, radiation, immunotherapy, or targeted therapy for gastric cancer within the past 2 weeks
- Grade 3 or 4 gastrointestinal bleeding within the past 3 months
- History of arterial or vascular embolism event including myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months
- Active infection, symptomatic congestive heart failure, unstable angina, symptomatic or uncontrolled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or other serious uncontrolled medical conditions
- History of gastrointestinal perforation or fistula within the past 6 months
- Diagnosis of cancer at another site or history of active malignant tumor within the past 3 years, excluding fully cured basal cell carcinoma, thyroid cancer, and in situ cervical cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kangbuk Samsung Hospital
Seoul, South Korea, 110-746
Actively Recruiting
Research Team
D
Dong-Hoe Koo, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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