EUCTR2019-003260-44-NL进行中（未招募）1 期
Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases. The PUMP-IT study - The PUMP-IT pilot study
Stichting Het Nederlands Kanker Instituut-Antoni van leeuwenhoek Ziekenhuis0 个研究点目标入组 31 人开始时间: 2020年9月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years.
- •ECOG performance status 0 or 1.
- •Life expectancy of at least 12 weeks.
- •Histologically confirmed CRC
- •Indication for first or second line systemic therapy, confirmed in a multidisciplinary meeting.
- •Potentially resectable (i.e. unresectable and upfront resectable CRLM with indication for neoadjuvant systemic therapy), confirmed in a multidisciplinary meeting and radio-logically on (PET) CT thorax/abdomen and/or MRI obtained = 4 weeks prior to regis-tration.
- •Positioning of a catheter for HAIP chemotherapy is technically feasible confirmed in the multidisciplinary liver meeting based on imaging. The default site for the catheter insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no contra-indication for catheter implantation. The GDA should have at least one branch to the liver, accessory or aberrant hepatic arteries should be ligated to allow for cross perfusion to the entire liver through intrahepatic shunts.
- •Indication and eligibility for abdominal surgery confirmed in a multidisciplinary meet-ing, e.g. primary tumour resection, stoma revision/reversal and diagnostic surgery.
- •In case of primary tumour in situ: tumour should be (potentially) resectable, confirmed in a multidisciplinary meeting.
- •Adequate bone marrow, liver and renal function as assessed by the following laborato-ry requirements to be conducted within 15 days prior to inclusion.
- •oHb = 5.5 mmol/L
- •oAbsolute neutrophil count (ANC) =1.5 * 109/L
- •oPlatelets =100 * 109/L
- •oTotal bilirubin < 1.5 mg/dL
- •oASAT = 5 * times the upper limit of normal (ULN)
- •oALAT = 5 * ULN
- •oAlkaline phosphatase = 5 * ULN
- •o(estimated) glomerular filtration rate (eGFR) > 45 ml/min.
- •Before patient registration, written informed consent must be given and signed accord-ing to ICH-GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •Extrahepatic metastases. Confirmed with CT thorax/abdomen obtained = 4 weeks prior to registration. Patients with small (= 1 cm) extrahepatic lesions that are not clear-ly suspicious of metastases are eligible.
- •Prior hepatic radiation, resection (other than biopsy), or ablation.
- •Concurrent malignancies that interfere with the planned study treatment or the prog-nosis of CRLM.
- •Participation in other clinical trials interfering with the study treatment as judged by the treating physician.
- •Dihydropyrimidine dehydrogenasedeficiency (DPD deficiency).
- •Pregnant or lactating women.
- •Serious concomitant systemic disorders that would compromise the safety of the pa-tient 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).
- •History of psychiatric disability judged by the investigator to potentially hamper com-pliance with the study protocol and follow-up schedule.
- •Any psychological, familial, sociological or geographical condition potentially hamper-ing compliance with the study protocol and follow-up schedule.
研究者
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