Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery (PUMP IV)
Prevención de la recurrencia del hígado después de la hepatectomía parcial para el colangiocarcinoma intrahepático utilizando la quimioterapia adyuvante de la bomba de infusión arterial hepática - Trial de la bomba IV IV
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:
- Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?
- Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?
- Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bas Groot Koerkamp, MD, PhD
- Número de teléfono: +31(0)107031810
- Correo electrónico: b.grootkoerkamp@erasmusmc.nl
Copia de seguridad de contactos de estudio
- Nombre: Thomas C Zwaan, MD
- Número de teléfono: +31(0)621218051
- Correo electrónico: t.zwaan@erasmusmc.nl
Ubicaciones de estudio
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South Holland
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Rotterdam, South Holland, Países Bajos, 3015GD
- Reclutamiento
- Erasmus Medical Center
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Contacto:
- Bas Groot Koerkamp, MD, PhD
- Número de teléfono: +31(0)107031810
- Correo electrónico: b.grootkoerkamp@erasmusmc.nl
-
Contacto:
- Thomas C Zwaan, MD
- Número de teléfono: +31(0)621218051
- Correo electrónico: t.zwaan@erasmusmc.nl
-
Investigador principal:
- Bas Groot Koerkamp, MD, PhD
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years or older
- ECOG or WHO performance status 0 or 1
- Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
- Patient is able to undergo a laparotomy.
- Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
- Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^ 9/L
- White blood cell count (WBC) ≥ 2.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Glomerular filtration rate (GFR) ≥ 30 ml/min
- Haemoglobin (Hb) ≥ 5.5 mmol/L
- Total bilirubin ≤ 25 µmol/L
- Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.
Exclusion Criteria:
- Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
- Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
- Prior hepatic radiation, ablation, or resection for iCCA.
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
- (Partial) portal vein thrombosis in future liver remnant.
- Pregnant or lactating women.
- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- Organ allografts requiring immunosuppressive therapy.
- Serious infections (uncontrolled or requiring treatment).
- Participation in another interventional study for iCCA with survival as outcome.
- Participation in another prospective study with an interventional medical product.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy)
Surgery + chemo pump |
Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Two-year hepatic recurrence free survival (hRFS)
Periodo de tiempo: From pump implantation until 2 years after that surgery
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The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. |
From pump implantation until 2 years after that surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall recurrence free survival (RFS)
Periodo de tiempo: From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
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The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples. |
From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
|
|
Overall survival (OS)
Periodo de tiempo: From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
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OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up |
From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
|
|
Post-operative complications
Periodo de tiempo: From pump implantation until 90 days after surgery
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All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery. |
From pump implantation until 90 days after surgery
|
|
Chemotherapy related adverse events (AEs)
Periodo de tiempo: From inclusion until 4 weeks after the end of treatment with chemotherapy
|
Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0 |
From inclusion until 4 weeks after the end of treatment with chemotherapy
|
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Proportion of patients started with HAIP chemotherapy
Periodo de tiempo: From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
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The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin |
From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
|
|
Quality of life: EORTC QLQ-30
Periodo de tiempo: From inclusion until 5 years after surgery
|
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. |
From inclusion until 5 years after surgery
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Quality of life: EQ-5D
Periodo de tiempo: From inclusion until 5 years after surgery
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After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible. After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years. |
From inclusion until 5 years after surgery
|
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Cost-effectiveness
Periodo de tiempo: From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
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An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made |
From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
|
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Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
Periodo de tiempo: From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
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A total of five additional blood samples will be collected. These samples will be collected:
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From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
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Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
Periodo de tiempo: From resection until 25 years after (conform applicable laws)
|
Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers. |
From resection until 25 years after (conform applicable laws)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Colangiocarcinoma
- Cirrosis, familiar, con hipertensión pulmonar
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Ácidos nucleicos, nucleótidos y nucleósidos
- Nucleósidos de pirimidina
- Pirimidinas
- Nucleósidos
- Desoxirribonucleósidos
- Desoxiuridina
- Uridina
- Floxuridina
Otros números de identificación del estudio
- MEC-2024-0324
- 2024-513726-33-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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