Hepatic arterial infusion pump chemotherapy in patients with unresectable intrahepatic cholangiocarcinoma
- Conditions
- Unresectable intrahepatic cholangiocarcinomaunresectable bileduct cancer in the liver.1001981510019818
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
• 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
placement.
• 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
•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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate efficacy, expressed by OS,<br /><br>of HAIP chemotherapy and concurrent systemic chemotherapy in patient with<br /><br>unresectable ICC in the Netherlands</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives include postoperative complications, chemotherapy related<br /><br>adverse events, 2-, 3- and 5-years OS, progression free survival (PFS),<br /><br>response rate, conversion to resection rate, quality of life, and<br /><br>cost-effectiveness. The accuracy of CT angiography to detect extrahepatic<br /><br>perfusion will be measured. Next, we aim to identify predictive biomarkers for<br /><br>the efficacy of HAIP chemotherapy.<br /><br>In 5 patients at Erasmus MC, we aim to perform a PSMA PET-CT/MRI to measure<br /><br>PSMA expression in ICC tumours.</p><br>