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

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ClinicalTrials.gov Identifier: NCT04556214
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

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..

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Procedure: Liver Transplant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2035
Estimated Study Completion Date : May 31, 2035


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Disease free survival [ Time Frame: After liver transplantation and up 10 years after liver transplantation ]
    CT-scan/MRI scan according to RECISTcriteria

  3. Start of new treatment/Change of strategy [ Time Frame: Immediately after liver transplatation to start of new treatment ]
    Time to start of new treatment

  4. 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),

  5. Liver transplant Complication [ Time Frame: Up to 90 days after liver transplantation ]
    Number of Clavien-Dindo grad 3-5 complications

  6. Number of Participants Developing other Malignancies [ Time Frame: Up to 10 years after liver transplantation ]
    Diagnosis of other malignancies

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556214


Contacts
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Contact: Svein Dueland, PhDMD +4722934000 svedue@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0310
Contact: Svein Dueland, MD    22934000 ext 47    svein.dueland@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Svein Dueland, PhDMD Oslo University Hospital
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Responsible Party: Svein Dueland, Senior consultant medical oncology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04556214    
Other Study ID Numbers: TESLA trial
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms