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

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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)

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..
    



Study Type

Interventional


Primary Outcome

Overall Survival (OS)

Secondary Outcome

 Overall Survival from time of relapse

Condition

Intrahepatic Cholangiocarcinoma

Intervention

Liver Transplant

Study Arms / Comparison Groups

 Liver Transplant
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

15

Start Date

June 1, 2020

Completion Date

May 31, 2035

Primary Completion Date

May 31, 2035

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Svein Dueland, PhDMD, +4722934000, [email protected]

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT04556214

Organization ID

TESLA trial


Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital


Study Sponsor

Svein Dueland, PhDMD, Principal Investigator, Oslo University Hospital


Verification Date

October 2020