Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer
Status: Not yet recruiting

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 chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.

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 CICI, 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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  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) Willing and able to give written informed consent ECOG performance status 0 to 1 Adequate bone marrow function; neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 60mL/min/1.73m2.  Exclusion Criteria  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 Received prior systemic treatment for unresectable and/or metastatic extrahepatic biliary tract cancer (EBTC)  Any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease. Exceptions to these criteria are as follows:  Hypothyroidism following Hashimoto thyroiditis stable on hormone replacement Patients with vitiligo Any chronic skin disorders that does not require systemic treatment Use of immunosuppressive medication within 3 weeks prior to the dose of durvalumab (with the exception of topical or inhaled steroids, systemic corticosteroids at physiologic doses not exceeding &gt;10mg/d of prednisone or its equivalent. Known history of HIV Prior Self-Expandable Metal Stent (SEMS) placement Biliary obstruction of non-tumoral etiology Liver cirrhosis Child-Pugh B and C Implanted with a cardiac pacemaker Platelets < 100 x 109 mm3 or international normalized ratio (INR) > 1.5 History of organ transplantation Secondary tumor (except for a tumor treated with curative intent without recurrence for more than 5 years, non-melanoma skin cancer, treated carcinoma in situs without evidence of disease) Other concomitant disease or condition likely to significantly decrease life expectancy i.e., life expectancy is less than 3 months according to investigator judgement Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study e.g., due to language problems, psychological disorders, dementia, etc. of the participant Participation in another study with investigational drug within preceding 30 days Pregnancy or lactation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult