JPRN-UMIN000009280已完成2 期
A Phase II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy - JSWOG C3
PO Japan Southwest Oncology Research Support Organization(JSWOG)0 个研究点目标入组 51 人开始时间: 2012年11月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
51 patients were enrolled in this study. Median PFS was 5.5 months, and median OS was 13.5 months. The RR was 14.6%, and the DCR was 66.7%. Hypertension was the most common Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two patients suffered from grade 3 hand-foot syndrome. In mCRC patients, biweekly CAPIRI + bevacizumab appears effective and feasible as a second-line chemotherapy with relatively low toxicities, and has potential as a useful substitute for FOLFIRI + bevacizumab.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Massive pleural effusion or ascites that required drainage (2) Severe liver disease (3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment (4) Severe renal failure (5) Metastases to the CNS (6) History of active double cancer within 5 years (7) Complication of cerebrovascular disease or symptoms within 1 year (8) 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 (9) Radiation therapy within 4 weeks before enrollment (10) Administering antithrombotic drug within 10 days before enrollment (11) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (12) A bleeding tendency, coagulation disorder or abnormal coagulation factor (13) Uncontrollable peptic ulcer (14) History of gastrointestinal perforation within 1 year. (15) Patient with untreated traumatic bone fracture (16) Uncontrollable hypertension (17) Serious heart disease (18) History of severe allergy with 5-FU (19) Uncontrollable diarrhea (20) Interstitial pneumonitis (21) Inability of oral Agent intake (22) Requiring novel immunosuppressant and steroid (23) Receiving atazanavir sulfate (24) Severe infection disease (25) Treatment history of CPT-11 (26) Other conditions not suitable for this study
研究者
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