Clinical trial NCT04556214: Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Official title: Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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..


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From screening and until 36 months after inclusion
Secondary outcomes:
measure: Overall Survival from time of relapse
timeFrame: From time of relapse and until 36 months after inclusion
measure: Disease free survival
timeFrame: After liver transplantation and up 10 years after liver transplantation
measure: Start of new treatment/Change of strategy
timeFrame: Immediately after liver transplatation to start of new treatment
measure: Time to decrease in physical function and global health score
timeFrame: Up to 10 years after liver transplantation
measure: Liver transplant Complication
timeFrame: Up to 90 days after liver transplantation
measure: Number of Participants Developing other Malignancies
timeFrame: Up to 10 years after liver transplantation
measure: Survival in relation to biological markers
timeFrame: After Liver Transplant until 10 years after liver transplantation
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Magnus Smedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Sheraz Yaqub, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: