RecruitingNCT04556214Updated Apr 11, 2023

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

An interventional study of Liver Transplant in Intrahepatic Cholangiocarcinoma, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

Started Jun 2020; still recruiting 6 years 4 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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..

Conditions studied

Intrahepatic Cholangiocarcinoma

Browse trials for

Cholangiocarcinoma 914

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (estimated)

Study arms

Experimental
Liver Transplant
The patients will be transplanted according to standard procedures by the institutional protocol. The transplantation procedure is initiated by an exploratory laparotomy with clinical assessment and frozen section of the lymphnodes in the hepatoduodenal ligament and along the common hepatic artery/coeliac axis. Evidence of disease dissemination to these regional lymph nodes will be an absolute contraindication to transplantation.
Procedure: Liver Transplant

Interventions

ProcedureLiver Transplant
Liver Transplant

What researchers measure

Primary outcomes

Overall Survival (OS)
OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome
Time frame: From screening and until 36 months after inclusion

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Oslo University Hospital
Oslo, 0451, Norway
- Magnus Smedman, MD · Contact · torha@ous-hf.no · 23026600
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04556214
Lead sponsor: Oslo University Hospital
Responsible party: Magnus Smedman, MD (Consultant, gastrointestinal oncology, Oslo University Hospital) — Principal investigator
First posted: Sep 21, 2020
Start date: Jun 1, 2020
Primary completion: May 31, 2035 (estimated)
Completion: May 31, 2035 (estimated)
Last update: Apr 11, 2023

Study contacts

Magnus Smedman, MD

Contact

torha@ous-hf.no

23026600 ext. +47

Magnus Smedman, MD

principal investigator · Oslo University Hospital

Sheraz Yaqub, MD, PhD

principal investigator · Oslo University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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