A multicenter, single-arm, phase II study of ramucirumab plus FOLFIRI with 150 mg/m2 irinotecan, standard Nippon dose, as the second-line treatment for Japanese patients with metastatic colorectal cancer - Study rindo

agoya University Graduate School of Medicine0 个研究点目标入组 60 人开始时间: 2017年4月1日最近更新: 2023年10月17日

适应症

试验速览

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•1. Previous history of severe drug-induced allergy 2. Brain metastasis 3. Cerebrovascular disease or its symptoms within 1 year. 4. Massive pleural effusion or ascites that required drainage. 5. History of active double cancer. 6. Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. 7. Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 8. History of gastrointestinal perforation within 1 year. 9. Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. 10. Severe renal failure or urinary protein (more than 2+). 11. Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). 12. Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated. 13. Interstitial lung disease or pulmonary fibrosis. 14. Uncontrolled infection. 15. Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. 16. UGT1A1 gene status of homo type (*28/*28, *6/*6) or double hetero-type genetic polymorphisms *28 or *6 (*1/*28 and *1/*6). 17. Prior irinotecan or ramucirumab containing chemotherapy 18. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. 19. Not appropriate for the study at the physician's assessment.

发起方

agoya University Graduate School of Medicine