Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04556214 |
Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : April 11, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intrahepatic Cholangiocarcinoma | Procedure: Liver Transplant | Not Applicable |
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 |
- 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
- 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
- Disease free survival [ Time Frame: After liver transplantation and up 10 years after liver transplantation ]CT-scan/MRI scan according to RECISTcriteria
- Start of new treatment/Change of strategy [ Time Frame: Immediately after liver transplatation to start of new treatment ]Time 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),
- Liver transplant Complication [ Time Frame: Up to 90 days after liver transplantation ]Number of Clavien-Dindo grad 3-5 complications
- Number of Participants Developing other Malignancies [ Time Frame: Up to 10 years after liver transplantation ]Diagnosis of other malignancies
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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
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
Contact: Magnus Smedman, MD | 23026600 ext +47 | torha@ous-hf.no |
Norway | |
Oslo University Hospital | Recruiting |
Oslo, Norway, 0451 | |
Contact: Magnus Smedman, MD 23026600 ext 47 torha@ous-hf.no |
Principal Investigator: | Magnus Smedman, MD | Oslo University Hospital | |
Principal Investigator: | Sheraz Yaqub, MD, PhD | Oslo University Hospital |
Responsible Party: | Magnus Smedman, MD, Consultant, gastrointestinal 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: | April 11, 2023 |
Last Verified: | April 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |