A phase 1B/2 study of trastuzumab, bevacizumab with paclitaxel for HER2-positive gastric cancer in a second-line therapy
- Conditions
- Neoplasms
- Registration Number
- KCT0008209
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 47
1) HER2 positive progressive gastric cancer
- It is defined as IHC 3+ or SISH + (or FISH) IHC 2+ evaluated by laboratory tests (SISH positive is defined as the ratio of HER2 gene copy number to CEP17 signal 2 2.0).
- Alternatively, significant overexpression of HER2 protein on multiple reaction monitoring
2) Patients with advanced disease for one systemic chemotherapy for progressive gastric cancer
3) Patients who are willing and capable of preparing a written test subject consent form for this test subjects
4) Patients who are 19 years of age or older at the time of signing the consent form for the test subjects.
5) Patients with measurable or assessable lesions according to RECIST 1.1.
6) ECOG Activity Chart Status 0, 1 or 2
7) He's a patient with adequate organ function.
- Laboratory examination within 2 weeks prior to start of treatment showed absolute neutrophils (ANC) 11.5 x 109/L, platelets 100100 x 109/L, hemoglobin 99 g/dL, serum creatinine 11.5 x ULN, total bilirubin 33.0 mg/dL, AST/ALT 55 xUL
- Echocardiogram EF 5555% or MUGA scan 5050%
8) Patients with urea protein <2+ in urinary analysis (if 22+ in dipstick or general urea analysis, protein <1000 mg must appear in the 24-hour urea collection for protein testing in order to be allowed to participate in clinical trials).
9) Women with childbearing agree to follow effective contraception for at least 7 months after participation in the test and final administration of the drug, and negative results must be obtained on urine or serum pregnancy tests conducted within 14 days prior to the first administration of the drug.
10) Men who are not infertile should agree to follow effective contraception for at least 7 months after participation in the test and final administration of the test drug.
1) Patients who have received chemotherapy, radiation therapy, immunotherapy, or targeted therapy for gastric cancer treatment within the last two weeks.
2) Patients who experienced gastrointestinal bleeding of Grade 3-4 within 3 months
3) Patients who have experienced arterial vascular embolism events within six months, including, but not limited to, myocardial infarction, transient ischemia, cerebrovascular disorders, or unstable angina.
4) Patients with ongoing or active infections, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorders, or any other significant medical impairment not controlled by the examiner's judgment
5) Patients with ongoing or active mental illness or in social situations that constrain compliance with clinical trial requirements.
6) Patients known to have active central nervous system (CNS) metastasis and/or carcinoma meningitis. Patients previously treated for brain metastasis are clinically stable (no evidence of disease progression on imaging for at least 4 weeks prior to the first dose of the drug and all neurological symptoms recover to baseline levels), and are eligible to participate if steroids have not been used for at least 7 days prior to administration. However, this exception does not apply to carcinomatous meningitis regardless of clinical stability.
7) Patients with a history or evidence of non-infectious epileptic pneumonia.
8) Patients with a known history of HIV (HIV-1/2 antibody).
9) Patients with known active hepatitis B (e.g. positive for HBsAg and with HBV DNA detected) or hepatitis C (anti-HCV positive and with [positive] HCV RNA).
10) Patients with a history of gastrointestinal perforation or fistula within 6 months.
11) Patients with clinically significant ascites due to a history of cirrhosis or hepatic encephalopathy above Child-Pugh B: clinically significant ascites mean ascites of the Common Terminology Criteria for Adverse Events (CTCAE) level >1. Patients who do not need further ascites-related procedures and are well regulated with medication for more than 3 months and have no evidence of ascites are recognized.
12) History of active malignant tumors that have been diagnosed with cancer in other areas at the same time or have occurred within the past three years.
- Except for completely cured skin basal cell carcinoma, thyroid cancer, and in situ cervical cancer.
13) When allergy, hypersensitivity, or prohibition of use is known for trastuzumab, bevacizumab, or Pachlitaxel drug components.
14) Patients who have difficulty breathing or need oxygen supplementation during severe stabilization due to progressive malignant tumors.
15) Women who are breastfeeding or pregnant, and women and men planning to conceive
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method overall survival