2024-512850-10-00招募中3 期
Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score – a randomized controlled trial
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)13 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2024年10月8日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 13
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
The primary objective is to compare the efficacy of surgery and adjuvant HAIP chemotherapy, assessed by progression free survival (PFS), with surgery alone in patients with resectable colorectal liver metastases with a low clinical risk score (CRS 0-2).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ECOG performance status 0 or 1
- •Clinical Risk Score (CRS) of 0-2
- •Histologically confirmed colorectal cancer (CRC)
- •Radiologically confirmed CLM amenable for resection or open ablation
- •Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT with early arterial phase with 1mm cuts
- •Adequate bone marrow, liver and renal function 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.
- •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
- •Serious, non-healing wound, ulcer, or bone fracture
- •Organ allografts requiring immunosuppressive therapy
- •Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent excluding inhaled steroids)
- •Serious infections (uncontrolled or requiring treatment). • Participation in another interventional study for CLM with survival as outcome.
- •Participation in another interventional study for CLM with survival as outcome.
- •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.
- •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, resection, or ablation
- •Prior hepatic radiation, resection, or ablation
- •CLM requiring two-staged resections.
- •Liver-first resections
- •Postoperative radiation of non-surgically treated (resection or open ablation) CLM
- •(Partial) portal vein thrombosis
- •Known DPD-deficiency (heterozygous or homozygous)
- •Pregnant women or lactating women
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
progression free survival (PFS)
progression free survival (PFS)
次要结局
- Overall survival
- Progression free survival in the liver
- Postoperative complications
- adverse events
- Quality of life
- Cost effectiveness
- the accuracy of CT angiography to detect extrahepatic perfusion
- pharmacokinetic profile of intra-arterial administration of floxuridine will
- predictive biomarkers for the efficacy of HAIP chemotherapy
研究者
Prof.dr. Groot Koerkamp
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (13)
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