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Tests treatment safety and results for Bile Duct Cancer
Official title Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer
ClinicalTrials.gov ID: NCT06274879
What this study is testing
What is Gemcitabin, Cisplatin and Durvalumab?
Gemcitabin, Cisplatin and Durvalumab is an investigational medicine, being studied as a potential treatment for bile duct cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥18 years old.
- Histologically or cytologically confirmed diagnosis of previously untreated and unresectable\ , locally advanced and/or metastatic extrahepatic...
- ECOG performance status 0 to 2.
- Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
- Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL/min/1.73m2.
You likely can't join if
- 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...
- In case of immune-checkpoint-inhibitor (ICI) administration, any autoimmune diseases including inflammatory disorders such as Crohn's disease...
- Use of immunosuppressive medication within 3 weeks prior to ICI administration. Exceptions: \- Topical or inhaled steroids.
- Systemic corticosteroids at physiologic doses not exceeding \>10mg/d of prednisone or equivalent.
- Prior Self-Expandable Metal Stent (SEMS) placement in the biliary tree.
See the full eligibility 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...
- ECOG performance status 0 to 2.
- Adequate bone marrow function: Neutrophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L.
- Adequate renal function in case of cisplatin administration: Estimated Glomerular Filtration Rate (eGFR) ≥60mL/min/1.73m2.
- Willing and able to provide written informed consent.
- Planned initiation of any standard-of-care systemic anti-proliferative therapy against ETB. \ The reason for inoperability needs to be documented and categorized as follows:
- Wish of patient.
- Locally advanced or vascular invasion = surgically not removable.
- Remnant liver is not sufficient.
- Anatomic contraindications.
- Distant metastasis.
- Severe comorbidities.
- Other reasons.
- 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...
- Use of immunosuppressive medication within 3 weeks prior to ICI administration. Exceptions: \- Topical or inhaled steroids.
- Systemic corticosteroids at physiologic doses not exceeding \>10mg/d of prednisone or equivalent.
- Prior Self-Expandable Metal Stent (SEMS) placement in the biliary tree.
- Biliary obstruction of non-tumoral etiology.
- Platelets \ 1.5.
- 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.
- Pregnancy or lactation.
- 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 candidate.
- Participation in another treatment study within 30 days prior to enrollment.
- Previous participation in the current study.
- Other diseases like Human Immunodeficiency Virus, Liver cirrhosis Child-Pugh B or C, cardiac pacemaker, history of organ transplantation or condition likely to significantly decrease life expectancy i.e., life...
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
- Geneva, Switzerland
- Lucerne, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland; Geneva, Switzerland; Lucerne, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.