CTIS2024-513726-33-00进行中（未招募）1 期
Preventing liver recurrence after partial hepatectomy for intrahepatic cholangiocarcinoma using adjuvant hepatic arterial infusion pump chemotherapy – PUMP IV trial - PUMP IV
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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 65+（—）
- 性别
- All
入选标准
- •Age = 18 years, ECOG performance status 0 or 1, Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care., Patient is able to undergo a laparotomy, Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the 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: oAbsolute neutrophil count (ANC)= 1.5 x 109/L oWhite blood cell count (WBC) = 2.5 x 109/L oPlatelets = 100 x 109/L oGlomerular filtration rate (GFR)= 30 ml/min oHaemoglobin (Hb) = 5.5 mmol/L oTotal bilirubin = 25 µmol/L, Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations
排除标准
- •Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (= 1 cm) extrahepatic lesions that are too small to characterise or biopsy are eligible., Organ allografts requiring immunosuppressive therapy., Serious infections (uncontrolled or requiring treatment)., Participation in another interventional study for iCCA with survival as outcome., Participation in another prospective study with an interventional medical product., 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., 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 homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency., Prior hepatic radiation, ablation, or resection for iCCA, Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed., (Partial) portal vein thrombosis in future liver remnant., 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.
研究者
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