Unresectable intrahepatic cholangiocarcinoma
Conditions
Interventions
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years. • ECOG performance status 0 or 1 (Appendix A). • Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma (ICC). • Unresectable ICC confined to the liver (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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Postoperative complications (Clavien-Dindo classification, grade III or higher, appendix F) • Chemotherapy related adverse events (chemotherapy related according CTCAE, grade III or higher, appendix E) • Progression free survival, is defined as the interval between surgery (pump implantation) and the earliest occurrence of disease progression. Either progression based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or the confirmed emerge of local non-primary, metastastic, or nodal disease. • Response rate, is measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Response rate is defined as a complete reponse, a partial response, or stable disease. • Conversion to resection rate, defined as the rate of patients who will receive a resection of the ICC after study treatment. • Quality of life measured with QLQ-C30 (appendix C), EQ-5D (appendix D) • Cost-effectiveness • Accuracy of CT angiography to detect extrahepatic perfusion • To identify biomarkers that predict the efficacy of HAIP chemotherapy ;Timepoint(s) of evaluation of this end point: After inclusion of the last patient, one year after inclusion of the last patient, 2 years after inclusion of the last patient and 5 years after inclusion of the last patient. | — |
Countries
Netherlands
Contacts
Public ContactResearcher
Erasmus MC
Outcome results
None listed