Regional chemotherapy for patients with inoperable bileduct cancer in the liver.
- Conditions
- nresectable intrahepatic cholangiocarcinomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004013-41-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
•Age = 18 years.
•ECOG performance status 0 or 1 (Appendix A).
•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 amenable to resection. Unresectability confirmed:
oRadiologically
oOr 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 15 days prior to inclusion:
oabsolute neutrophil count (ANC) =1.5 x 109/L
o platelets =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) >50 ml/min.
•Written informed consent must be given according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
•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, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence.
•Failure to prior chemotherapeutical regime for cholangiocarcinoma.
•Known DYPD deficiency
•Prior hepatic radiation, ablation, or resection for cholangiocarcinoma.
•Known intolerance to gemcitabine or cisplatin.
•Life expectancy of less than 12 weeks
•Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Surgically related ascites does not exclude the patient.
•(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 investigational drug or participation in another interventional study.
•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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate efficacy, expressed by OS, of HAIP chemotherapy and concurrent systemic chemotherapy in patient with unresectable ICC in the Netherlands. ;Secondary Objective: Secondary objectives include postoperative complications, chemotherapy related adverse events, progression free survival (PFS), response rate, conversion to resection rate, quality of life, and cost-effectiveness. The accuracy of CT angiography to detect extrahepatic perfusion will be measured. Next, we aim to identify predictive biomarkers for the efficacy of HAIP chemotherapy;Primary end point(s): The primary endpoint is one-year overall survival (OS). ;Timepoint(s) of evaluation of this end point: 1 year after inclusion of the last patient.
- Secondary Outcome Measures
Name Time Method