IRCT20240627062267N1招募中3 期
Comparative analysis of the efficacy of Irinotecan-loaded drug-eluting beads (DEBIRI) in combination with systemic chemotherapy versus chemotherapy alone in unresectable colorectal cancer liver metastases: a randomized clinical trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Patients with histologically proven, unresectable or borderline resectable liver metastases from colorectal origin, who are 18 years or older and
- •Patients who are chemotherapy-naïve for their metastatic disease
- •Metastases burden must be exclusively or predominantly limited to the liver.
- •Adequate hematologic, hepatic, and renal function ( ANC = 1.5 × 10^9/L•PLT = 75 × 10^9/L•INR = 1.3•Total bilirubin = 2.0 mg/dL•AST and ALT = ×5 the upper limit of normal (ULN)•Albumin = 2.5 g/dL•Creatinine = 2.0 mg/dL)
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
排除标准
- •Patients who are candidates for curative surgery without the need for neoadjuvant therapy
- •Liver involvement of = 70%
- •Presence of brain metastases
- •Peritoneal carcinomatosis
- •Presence or History of an allergic reaction to any of the study drugs
- •Chronic viral hepatitis B or C
- •Pregnancy (based on elevated serum or urine B-HCG level)
- •Breastfeeding
- •Patient’s refusal to participate in the study
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