Combination therapy for advanced HER2-positive gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, phase 2 study evaluates the effectiveness of a combination of trastuzumab, bevacizumab, and paclitaxel as a second-line treatment for patients with HER2-positive advanced gastric cancer who have not responded to first-line chemotherapy. The treatment regimen includes specific dosing schedules for each drug to maintain therapeutic levels while managing side effects. The study aims to assess the safety and efficacy of this triple combination therapy in improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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)
2. Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer
3. Patients who are willing and able to write a written consent form for this trial.
4. Patients aged 19 years or older at the time of signing the subject consent form.
5. Patients with measurable or evaluable lesions according to RECIST 1.1.
6. ECOG activity status 0, 1 or 2
7. 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%

Exclusion Criteria:

1. Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks.
2. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months
3. 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
4. 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
5. Patients with a history of gastrointestinal perforation or fistula within 6 months.
6. 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

Where it's running

• Kangbuk Samsung Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Dong-Hoe Koo, MD,PhD — Kangbuk Samsung Hospital
• Study coordinator: Dong-Hoe Koo, MD,PhD
• Email: dhkoo.smc@gmail.com
• Phone: +82-2-2001-8330

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Bevacizumab added or not to T-DXd for HER2-low breast cancer with brain metastases

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• RC48 with bevacizumab or pyrotinib for HER2-positive metastatic breast cancer after T-Dxd failure

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07065435

• Combination treatment for HER2 positive metastatic colorectal cancer

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• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.