NL-OMON20478招募中不适用
Adjuvant hepatic arterial infusion pump chemotherapy after repeat hepatectomy for patients with liver confined recurrence of colorectal cancer – a phase II study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
研究概览
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age = 18 years.
- •ECOG performance status 0 or 1.
- •Histologically confirmed colorectal cancer (CRC).
- •Liver only recurrence after previous local treatment of index CRLM
- •Radiologically confirmed and resectable CRLM. Criteria for resectability are outlined in section 5.1.
- •Positioning of a catheter for HAIP chemotherapy is technically feasible (see chapter 5) 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:
- •oAbsolute neutrophil count (ANC) =1.5 x 109/L
- •oPlatelets =100 x 109/L
- •oHB = 5.5 mmol/L
- •oTotal bilirubin = 1.5 UNL
- •oASAT = 5 x UNL
- •oALAT = 5 x UNL
- •oAlkaline 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
- •Recurrence CRLM at same location as previously unsuccessfully (i.e. residual disease) 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 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.
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