NCT05640830RecruitingPhase 1/2
Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 25 Nov 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Kangbuk Samsung Hospital
- NCT number
- NCT05640830
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 47
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks.
- 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
Other illness
- 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
- Patients with a history of gastrointestinal perforation or fistula within 6 months.
Who the study is looking for
- 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%
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.