NL-OMON52590招募中2 期
Hepatic arterial infusion pump chemotherapy in patients with unresectable intrahepatic cholangiocarcinoma - Hepatic Arterial Infusion Pump chemotherapy for unresectable ICC.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
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 64（—）
入选标准
- •Age >= 18 years.
- •ECOG performance status 0 or 1
- •Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma (ICC).
- •Unresectable ICC confined to the liver (<70% of the liver involved) with or
- •without limited regional lymph node disease (portal) at initial presentation,
- •as confirmed by HPB surgeons. Regional lymph nodes will be allowed, provided it
- •is potentially amenable to resection.
- •Unresectability confirmed:
- •o Radiologically
- •o Or during surgical exploration in patients initially considered candidates
- •for resection
- •Patient is able to undergo a laparotomy or minimal-invasive surgery for pump
- •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.
- •Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements to be conducted within 30 days prior to inclusion:
- •o Absolute neutrophil count (ANC) >= 1.5 x 109/L
- •o White blood cell count (WBC) >= 2.5 x 109/L
- •o Platelets >= 100 x 109/L
- •o Glomerular filtration rate (GFR) >= 50 ml/min
- •o Haemoglobin (HB) >= 5.5 mmol/L
- •o Total bilirubin <= 25 µmol/L
排除标准
- •Presence of extrahepatic disease at the time of first presentation. Patients
- •with limited (portal) lymph node disease, patients with small (<= 1 cm)
- •extrahepatic lesions that are too small to characterize are eligible.
- •Second primary malignancy, except for adequately treated non-melanoma skin
- •cancer, or other malignancy treated at least 3 years previously without
- •evidence of recurrence or with a life expectancy longer than 5 years.
- •Known DPYD deficiency. Patients with intermediate DPYD metabolism ( DPD
- •activity score: 1.5) are eligible and a 50% reduced starting dose of
- •floxuridine will be administered by discretion of the medical oncologist.
- •Prior hepatic radiation, ablation, or resection for cholangiocarcinoma.
- •Life expectancy of less than 12 weeks.
- •Clinical evidence of portal hypertension (ascites, gastroesophageal varices,
- •or portal vein thrombosis). Surgically related ascites is allowed.
- •(Partial) portal vein thrombosis.
- •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).
- •Participation in another interventional study for ICC with survival as
- •Participation in another prospective study with an interventional medical
- •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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