Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556214
• Other study ID #: TESLA trial
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 31, 2035

Study information

• Verified date: April 2023
• Source: Oslo University Hospital
• Contact: Magnus Smedman, MD
• Phone: 23026600
• Email: torha[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 31, 2035
• Est. primary completion date: May 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Procedure:
• Liver Transplant
Liver Transplant

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome	From screening and until 36 months after inclusion
Secondary	Overall Survival from time of relapse	OS as assessed by QLQ-C30 patient reported outcome	From time of relapse and until 36 months after inclusion
Secondary	Disease free survival	CT-scan/MRI scan according to RECISTcriteria	After liver transplantation and up 10 years after liver transplantation
Secondary	Start of new treatment/Change of strategy	Time to start of new treatment	Immediately after liver transplatation to start of new treatment
Secondary	Time to decrease in physical function and global health score	Quality of life measured by EORTC QLQ-C30),	Up to 10 years after liver transplantation
Secondary	Liver transplant Complication	Number of Clavien-Dindo grad 3-5 complications	Up to 90 days after liver transplantation
Secondary	Number of Participants Developing other Malignancies	Diagnosis of other malignancies	Up to 10 years after liver transplantation
Secondary	Survival in relation to biological markers	CEA, CA 19-9 and Germline DNA analyses	After Liver Transplant until 10 years after liver transplantation