Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a treatment called biliary radiofrequency ablation (bRFA) for patients with bile duct cancer that cannot be surgically removed. The main goal is to see if it's safe to combine bRFA with standard chemotherapy (drugs called gemcitabine and cisplatin) and an immunotherapy drug called durvalumab. Participants will be divided into two groups: one group will receive the standard treatment, while the other will receive standard treatment plus the bRFA procedure. They will be monitored for six months to assess their health, any side effects, and their quality of life.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of unresectable bile duct cancer causing jaundice. They should have good overall health, with specific requirements for blood counts and kidney function. However, those with certain conditions, like previous treatments for bile duct cancer or autoimmune diseases, won't be eligible. Participants can expect regular check-ups and tests throughout the study to track their progress and any potential side effects from the treatments. This trial aims to gather important information about how adding bRFA affects safety and overall treatment outcomes for patients facing this challenging cancer.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Male or female ≥18 years old.
• • 2. 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).
• • 3. ECOG performance status 0 to 1.
• • 4. Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
• • 5. Adequate renal function: Estimated Glomerular Filtration Rate (eGFR) ≥50mL/min/1.73m2.
• • 6. Willing and able to provide written informed consent. \*The reason for inoperability needs to be documented and categorized as follows: - Locally advanced or vascular invasion = surgically not removable. - Distant metastasis.
• • Severe comorbidities.
• • Other reasons. Exclusion criteria
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• • 1. Solely intrahepatic cholangiocarcinoma or mixed type liver tumors (cholangiocarcinoma with hepatocellular differentiation parts).
• • 2. 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.
• • 3. Received prior systemic treatment for unresectable and/or metastatic Extrahepatic Biliary Tract Cancer (EBTC).
• • 4. Any autoimmune diseases including inflammatory disorders such as Crohn's disease, ulcerative colitis, Wegener granulomatosis, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease.
• Exceptions:
• • Hypothyroidism following Hashimoto thyroiditis stable on hormone replacement.
• • Patients with vitiligo.
• • Any chronic skin disorders that do not require systemic treatment.
• • 5. Use of immunosuppressive medication within 3 weeks prior to the dose of durvalumab.
• Exceptions:
• • - Topical or inhaled steroids.
• • - Systemic corticosteroids at physiologic doses not exceeding \>10mg/d of prednisone or equivalent.
• • 6. Known history of Human Immunodeficiency Virus.
• • 7. Prior Self-Expandable Metal Stent (SEMS) placement.
• • 8. Biliary obstruction of non-tumoral etiology.
• • 9. Liver cirrhosis Child-Pugh B or C.
• • 10. Platelets \<100 x 109/L or International Normalised Ratio (INR) \>1.5.
• • 11. History of organ transplantation.
• • 12. Secondary tumor.
• Exceptions:
• • - Tumor treated with curative intent without recurrence for more than 5 years.
• • Non-melanoma skin cancer treated carcinoma in situ without evidence of disease. 14. Other concomitant disease or condition likely to significantly decrease life expectancy i.e., life expectancy is less than 3 months according to investigator judgement.
• • 15. Pregnancy or lactation. A negative blood or urine pregnancy test must be available before administration of CICI.
• • 16. Known or suspected non-compliance, drug, or alcohol abuse. 17. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the candidate.
• • 18. Participation in another interventional study within 30 days prior to enrollment.
• • 19. Previous participation in the current study.