The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of systemic anti-tumor therapy with or without immune-checkpoint-inhibitor (ICI). The main question it aims to answer is whether it is safe to combine systemic anti-tumor therapy with or without ICI with and bRFA.
Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and systemic anti-tumor therapy, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.
Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate.
Male or female ≥18 years old.
Histologically or cytologically confirmed diagnosis of previously untreated and unresectable*, locally advanced and/or metastatic extrahepatic biliary tract cholangiocarcinoma with obstructive jaundice (increased serum level of total bilirubin).
ECOG performance status 0 to 2.
Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
Solely intrahepatic cholangiocarcinoma or mixed type liver tumors (cholangiocarcinoma with hepatocellular differentiation parts).
Multiple hepatic metastases with significant blockage of one or more liver segments and/or less than 50% of liver parenchyma potentially drainable on pre-intervention imaging.
In case of immune-checkpoint-inhibitor (ICI) administration, any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease.
Use of immunosuppressive medication within 3 weeks prior to ICI administration.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss Cancer League
Collaborator