NL-OMON47208招募中2 期
Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study - Adjuvant hepatic arterial infusion pump chemotherapy after resection of CLM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
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 至 99（—）
入选标准
- •Age >= 18 years.
- •ECOG performance status 0 or 1
- •Clinical Risk Score (CRS) of 0-5
- •Histologically confirmed colorectal cancer (CRC)
- •Radiologically confirmed and resectable CLM
- •Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT or MRI with adequate arterial phase.
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 15 days prior to inclusion.
排除标准
- •Presence of extrahepatic disease (including positive portal lymph nodes) at the time of liver resection or any time since CRC diagnosis. Patients with small (<= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
- •Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence.
- •Prior hepatic radiation or resection.
- •Two-staged liver resections
- •(Partial) portal vein thrombosis
- •Pregnant women or lactating women.
- •History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- •Organ allografts requiring immunosuppressive therapy.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Chronic treatment with corticosteroids (dose of >= 10 mg/day methylprednisolone equivalent excluding inhaled steroids).
- •Serious infections (uncontrolled or requiring treatment).
- •Current or recent (within the 28 days prior to inclusion) treatment with another investigational drug or participation in another investigational study.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
研究者
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