Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKangbuk Samsung Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 disorder not controlled in the investigator's judgment patient with
Trial design
Treatments tested in this trial
- trastuzumab, bevacizumab with paclitaxel (triple combination)
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov