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

Primary Purpose

Intrahepatic Cholangiocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Liver Transplant

About this trial

This is an interventional supportive care trial for Intrahepatic Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver Transplant

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome

Secondary Outcome Measures

Overall Survival from time of relapse

OS as assessed by QLQ-C30 patient reported outcome

Disease free survival

CT-scan/MRI scan according to RECISTcriteria

Start of new treatment/Change of strategy

Time to start of new treatment

Time to decrease in physical function and global health score

Quality of life measured by EORTC QLQ-C30),

Liver transplant Complication

Number of Clavien-Dindo grad 3-5 complications

Number of Participants Developing other Malignancies

Diagnosis of other malignancies

Survival in relation to biological markers

CEA, CA 19-9 and Germline DNA analyses

Full Information

NCT ID

NCT04556214

First Posted

June 30, 2020

Last Updated

April 10, 2023

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04556214

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

May 31, 2035 (Anticipated)

Study Completion Date

May 31, 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrahepatic Cholangiocarcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Liver Transplant

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Liver Transplant

Intervention Description

Liver Transplant

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome

Time Frame

From screening and until 36 months after inclusion

Secondary Outcome Measure Information:

Title

Overall Survival from time of relapse

Description

OS as assessed by QLQ-C30 patient reported outcome

Time Frame

From time of relapse and until 36 months after inclusion

Title

Disease free survival

Description

CT-scan/MRI scan according to RECISTcriteria

Time Frame

After liver transplantation and up 10 years after liver transplantation

Title

Start of new treatment/Change of strategy

Description

Time to start of new treatment

Time Frame

Immediately after liver transplatation to start of new treatment

Title

Time to decrease in physical function and global health score

Description

Quality of life measured by EORTC QLQ-C30),

Time Frame

Up to 10 years after liver transplantation

Title

Liver transplant Complication

Description

Number of Clavien-Dindo grad 3-5 complications

Time Frame

Up to 90 days after liver transplantation

Title

Number of Participants Developing other Malignancies

Description

Diagnosis of other malignancies

Time Frame

Up to 10 years after liver transplantation

Title

Survival in relation to biological markers

Description

CEA, CA 19-9 and Germline DNA analyses

Time Frame

After Liver Transplant until 10 years after liver transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Magnus Smedman, MD

Phone

23026600

Ext

+47

torha@ous-hf.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magnus Smedman, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sheraz Yaqub, MD, PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

0451

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magnus Smedman, MD

Phone

23026600

Ext

torha@ous-hf.no

12. IPD Sharing Statement

Learn more about this trial

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

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