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

April 10, 2023 updated by: Magnus Smedman, MD, Oslo University Hospital
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..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Magnus Smedman, MD
  • Phone Number: +47 23026600
  • Email: torha@ous-hf.no

Study Locations

  • Norway
      • Oslo, Norway, 0451
        • Recruiting
        • Oslo University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Liver Transplant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From screening and until 36 months after inclusion
OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome
From screening and until 36 months after inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: After liver transplantation and up 10 years after liver transplantation
CT-scan/MRI scan according to RECISTcriteria
After liver transplantation and up 10 years after liver transplantation
Overall Survival from time of relapse
Time Frame: From time of relapse and until 36 months after inclusion
OS as assessed by QLQ-C30 patient reported outcome
From time of relapse and until 36 months after inclusion
Start of new treatment/Change of strategy
Time Frame: Immediately after liver transplatation to start of new treatment
Time to start of new treatment
Immediately after liver transplatation to start of new treatment
Time to decrease in physical function and global health score
Time Frame: Up to 10 years after liver transplantation
Quality of life measured by EORTC QLQ-C30),
Up to 10 years after liver transplantation
Liver transplant Complication
Time Frame: Up to 90 days after liver transplantation
Number of Clavien-Dindo grad 3-5 complications
Up to 90 days after liver transplantation
Number of Participants Developing other Malignancies
Time Frame: Up to 10 years after liver transplantation
Diagnosis of other malignancies
Up to 10 years after liver transplantation
Survival in relation to biological markers
Time Frame: After Liver Transplant until 10 years after liver transplantation
CEA, CA 19-9 and Germline DNA analyses
After Liver Transplant until 10 years after liver transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Magnus Smedman, MD, Oslo University Hospital
  • Principal Investigator: Sheraz Yaqub, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2035

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TESLA trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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