NL-OMON55263尚未招募2 期
Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases - PUMP-IT
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 31 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •o Hb * 5.5 mmol/L
- •o Absolute neutrophil count (ANC) *1.5 * 109/L
- •o Platelets *100 * 109/L
- •o Total bilirubin < 1.5 mg/dL
- •o ASAT * 5 * times the upper limit of normal (ULN)
- •o ALAT * 5 * ULN
- •o Alkaline 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.
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 clearly 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
- •* Pregnant or lactating women.
- •* 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).
- •* History of psychiatric disability judged by the investigator to potentially
- •hamper compliance with the study protocol and follow-up schedule.
- •* Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow-up
研究者
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