Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated..
Interventions
PROCEDURELiver Transplant
Liver Transplant
Sponsors
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically verified diagnosis of Intrahepatic Cholangiocarcinoma (iCCA) * First time iCCA or liver only recurrence after previous liver resection for iCCA * Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction * No vascular invasion, extrahepatic disease, or lymph node involvement detected on imaging * No signs of extrahepatic metastatic disease according to positron emission computed tomography (PET-CT) scan * Patient must be accepted for transplantation before progressive disease on chemotherapy. * Twelve months or more time span from the diagnosis of iCCA and date of being listed for liver transplantation * No signs of extrahepatic metastatic disease according to CT or magnetic resonance (MR) scan within 4 weeks prior to the faculty meeting at the transplant unit * At least 18 years of age * Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Signed informed consent and expected cooperation of the patients for the treatment and follow up * Received at least 6 months of chemotherapy or locoregional therapy
Exclusion criteria
* Major vascular involvement of the tumor * Perforation of the visceral peritoneum * Weight loss \>15% the last 6 months * Patient BMI \> 30 * Other malignancies, except curatively treated more than 5 years ago without relapse * Known history of human immunodeficiency virus (HIV) infection * Prior history of solid organ or bone marrow transplantation * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Known hypersensitivity to rapamycin * Prior extrahepatic metastatic disease * Women who are pregnant or breast feeding * Any reason why, in the opinion of the investigator, the patient should not participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From screening and until 36 months after inclusion | OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | After liver transplantation and up 10 years after liver transplantation | CT-scan/MRI scan according to RECISTcriteria |
| Start of new treatment/Change of strategy | Immediately after liver transplatation to start of new treatment | Time to start of new treatment |
| Time to decrease in physical function and global health score | Up to 10 years after liver transplantation | Quality of life measured by EORTC QLQ-C30), |
| Overall Survival from time of relapse | From time of relapse and until 36 months after inclusion | OS as assessed by QLQ-C30 patient reported outcome |
| Number of Participants Developing other Malignancies | Up to 10 years after liver transplantation | Diagnosis of other malignancies |
| Survival in relation to biological markers | After Liver Transplant until 10 years after liver transplantation | CEA, CA 19-9 and Germline DNA analyses |
| Liver transplant Complication | Up to 90 days after liver transplantation | Number of Clavien-Dindo grad 3-5 complications |
Countries
Norway
Contacts
Primary ContactMagnus Smedman, MD
Outcome results
None listed