A multicenter, randomized, open label, phase III trial to evaluate the efficacy and safety of the combination of S-1, oxaliplatin and irinotecan in comparison to the combination of S-1 and cisplatin as first-line treatment in patients with metastatic or relapsed gastric cancer

Hallym University Medical Center0 个研究点目标入组 286 人开始时间: 待定最近更新: 2022年11月28日

试验速览

阶段: 未知
状态: 招募中
发起方: Hallym University Medical Center
入组人数: 286

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19(Year) 至 o Limit（—）
性别: All

入选标准

•1)Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.
•2)Measurable or evaluable lesion according to RECIST criteria v1.1
•3)Chemotherapy naïve patients (except for adjuvant or neoadjuvant chemotherapy, which was completed more than 6 months before randomization).
•4)Age 19 or more
•5)Eastern Cooperative Oncology Group performance status 0-1
•6)Adequate organ functions
•–Adequate bone marrow function: absolute neutrophil count >1,500/µL, Hb 9.0 g/dL, and platelets>100,000/µL
•–Adequate renal function: creatinine < 1.5 mg/dL or creatinine clearance > 60 ml/min
•–Adequate hepatic function: serum bilirubin = 2.5 x UNL (upper normal limit), AST and ALT = 2.5 x UNL (= 5 x ULN in the presence of liver metastasis)
•7)Estimated life expectancy of more than 3 months
•8)Given written informed consent prior to study-specific screening procedures

排除标准

•1)Other tumor types than adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma
•2)HER2-positive tumors
•3)Participated in other clinical trial within 4 weeks before randomization
•4)Prior radiotherapy on target lesion within 4 weeks before randomization
•5)Bowel obstruction or gastrointestinal bleeding precluding S-1 PO administration
•6)Surgery within 4 weeks before randomization
•7)Clinically significant cardiac disease (e.g. severe non-compensated hypertension, non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease with ST segment depression in ECG) or myocardial infarction within the last 12 months.
•8)Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
•9)Significant neurologic or psychiatric disorders including CNS metastasis
•10)History of another malignancy within the last two years except cured basal cell carcinoma f skin and cured carcinoma in–situ of uterine cervix.
•11)Peripheral neuropathy with functional impairment
•12)Hypersensitivity to drugs used in this clinical study
•13)Pregnant or lactating women, women of childbearing potential not employing adequate contraception. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
•14)Genetic disorders such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
•15)Severe diarrhea more than 3 grade or chronic inflammatory bowel disease
•16)diagnosed with interstitial pneumonia or pulmonary fibrosis
•17)Chicken pox patients
•18)Patients with hearing loss
•19)Patients who are considered difficult to participate in the clinical study by the researcher

研究者

发起方

Hallym University Medical Center

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