A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer
3-weekly/ 1cycle treatment * Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks * Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
* Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks * Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1
Asan Medical Center
Seoul, Seoul, South Korea
Efficacy (Overall tumor response)
Overall tumor response (responder/non-responder) which is a primary efficacy endpoint: is defined as the maximal response among confirmed cases of complete response (CR) or partial response (PR) determined by definite radiological assessment of target and nontarget lesions in accordance with RECIST criteria version 1.1.
Time frame: 2 years
progression free survival
Time from the start date of chemotherapy to the date of disease progression or death of any cause which comes first
Time frame: 2 years
Duration of response
Time from the date of tumor response by RECIST version 1.1 to the date of disease progression
Time frame: 2 years
Overall Survival
Time from the start date of chemotherapy to the date of death of any cause
Time frame: 2 years
Time to disease progression
Time from the start date of chemotherapy to the date of disease progression
Time frame: 2 years
Safety(Toxicity profile)
Assessed by NCI CTCAE version 5.0
Time frame: 2 years
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