NL-OMON50045招募中2 期
Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with recurrent colorectal liver metastases without a history of extrahepatic disease - a phase II study - PUMP -III trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
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
- •Adults with recurrent resectable CRLM without a history of EHD.
- •Age >= 18 years.
- •ECOG performance status 0 or 1.
- •Histologically confirmed colorectal cancer (CRC).
- •Liver only recurrence after previous resection of index CRLM
- •Radiologically confirmed and resectable CRLM.
- •Positioning of a catheter for HAIP chemotherapy is technically feasible based
- •on a CT with excellent arterial phase. The default site for the catheter
- •insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic
- •arteries are no contraindication for catheter placement. The GDA should have at
- •least one branch to the liver remnant; accessory or aberrant hepatic arteries
- •should be ligated to allow for cross perfusion to the entire liver through
- •intrahepatic shunts.
- •Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements to be conducted within 15 days prior to inclusion:
- •o absolute neutrophil count (ANC) >=1.5 x 109/L
- •o platelets >=100 x 109/L
- •o HB >= 5.5 mmol/L
- •o Total bilirubin <= 1.5 UNL
- •o ASAT <= 5 x UNL
- •o ALAT <= 5 x UNL
- •o alkaline phosphatase <= 5 x UNL
- •o (calculated) glomerular filtration rate (GFR) >30 ml/min.
- •Written informed consent must be given according to ICH/GCP, and
- •national/local regulations.
排除标准
- •A positive history of extrahepatic disease (including positive portal lymph
- •nodes) at any time since CRC diagnosis. Patients with small (<= 1 cm)
- •extrahepatic lesions that are too small to characterize 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..
- •CRLM requiring two-staged liver resections
- •recurrent CRLM at same location as previously resected/ablated CRLM and <6
- •months after its resection.
- •Known DPYD-deficiency.
- •Pregnant 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).
- •Inclusion in another interventional clinical study with survival as primary
- •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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