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New treatment option for HER2-positive Advanced Gastric Cancer
Official title Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
ClinicalTrials.gov ID: NCT05640830
What this study is testing
What is trastuzumab, bevacizumab with paclitaxel (triple combination)?
trastuzumab, bevacizumab with paclitaxel (triple combination) is an investigational medicine, given as an once-weekly, being studied as a potential treatment for her2-positive advanced gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- HER2-positive advanced gastric cancer
- Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy...
- or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)
- Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer
- Patients who are willing and able to write a written consent form for this trial.
You likely can't join if
- Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted 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 not limited to myocardial infarction, transient ischemic attack...
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias...
- Patients with a history of gastrointestinal perforation or fistula within 6 months.
- Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years
See the full eligibility criteria
- HER2-positive advanced gastric cancer
- Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the 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 for advanced 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 ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN
- Echocardiogram EF ≥55% or MUGA scan ≥50%
- Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted 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 not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical...
- Patients with a history of gastrointestinal perforation or fistula within 6 months.
- Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years
- Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.