In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group. The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks
cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks
S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ;
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: 5 years
Time to progression as measured by RECIST 1.1
Time frame: 5 years
Progression-free survival measured by RECIST 1.1
Time frame: 5 years
Treatment safety and toxicity as measured by Common Toxicity Criteria for Adverse Effects(CTCAE 3.0)
Time frame: 5 years
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