Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06274879

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

Intervencionista

Fase 2

Inselspital, Universitätsspital Bern

Patrocinador: Insel Gruppe AG, University Hospital Bern

Última actualización: 25 de marzo de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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.

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Categoría de tratamiento

Inhibidores de puestos de control, Quimioterapia, Procedimiento

Erforderliche Mutationen

Ninguna

Ensayo iniciado

1 de junio de 2025

Última actualización por el patrocinador

25 de marzo de 2025

Finalización estimada

30 de diciembre de 2026

Contacto del estudio

Nombre:Reiner Prof. Dr. med. Wiest

Correo electrónico:reiner.wiest@insel.ch

Teléfono:+41 31 632 59 41

Nombre:Martin Prof. Dr. med. Berger

Correo electrónico:martin.berger@insel.ch

Teléfono:+41 31 632 41 14

Elegibilidad

Criterios de inclusión

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.

Criterios de exclusión

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.

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Detalles del diseño

AsignaciónRandomized

Modelo de intervenciónParallel Assignment

EnmascaramientoNone (Open Label)

Número a inscribir36

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Active Comparator

Descripción: Standard of care consisting of chemotherapy + durvalumab + endoscopic stenting

Intervenciones:

Gemcitabin, Cisplatin and Durvalumab
Biliary Radiofrequency Ablation
Endoscopic Retrograde Cholangio-Pancreatography with stenting

Medidas de resultado

Medidas de resultado primarias

Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after randomization.6 months

AEs will be assessed according to US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5). Treatment discontinuation is defined as deferral of administration by at least four weeks or a definite stop of all CICI agents.

Medidas de resultado secundarias

Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions6 months

Current guideline definitions for cholangitis, post-ERCP pancreatitis and bleeding are applied. The rate of readmissions for biliary complications will be assessed specifically by being defined as any non-elective endoscopic reintervention after the first stent placement and will be documented in terms of timing, type of intervention, hospitalization and its duration and resolution.

Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C306 months

EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer questionnaire quality of life questionnaire core 30), scores range from 0 to 100, where a high scale score represents a higher response level.

Number of courses of CICI applied6 months

Total dose of CICI applied6 months

Disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle and at 3 and 6 months after the start of CICI treatment.6 months

EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer questionnaire for measuring quality of life in patients with cholangiocarcinoma and cancer of the gallbladder), scores range from 0 to 100, where a lower score means a better quality of life.

Stent patency at month 3 visit and at 6 months after the start of CICI treatment.6 months

Number of patients with any grade 3 or 4 Adverse Events (AE) leading to discontinuation or non-initiation of CICI up to six months after randomization.6 months

Number of patients not starting CICI within 4 weeks after randomization.6 months

Time from randomization to CICI start.6 months

Details of adverse events6 months

Progression-free survival: The time until either progression of the underlying disease or death, whichever occurs first, assessed from the time of up to 6 months after randomization.6 months

Death from any cause at the follow-up at 6 months after randomization (overall survival).6 months

Overall survival at 24 months after randomization24 months

This will be an investigator-initiated sub-study outside this protocol

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Sitios del ensayo

Inselspital, Universitätsspital Bern

Bern, Bern, CH

Nombre:Martin Prof. Dr. med. Berger

Correo electrónico:martin.berger@insel.ch

Teléfono:+41 31 632 41 14

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