Intrahepatic CholangiocarcinomaNCT04556214
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
A study testing Liver Transplant in people with Intrahepatic Cholangiocarcinoma, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Liver Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2020to 31 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0451
Magnus Smedman, MD, 23026600 ext. 47, torha@ous-hf.no
About this study
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..
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Liver Transplant
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantProcedure or surgery
Liver Transplant
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant | Experimental | 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. Receives: Procedure: Liver Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS as assessed by quality of life questionnaire (QLQ-C30) patient reported outcome
Measured: From screening and until 36 months after inclusion
Secondary outcomes (7)
Overall Survival from time of relapse
OS as assessed by QLQ-C30 patient reported outcome
Measured: From time of relapse and until 36 months after inclusion
Disease free survival
CT-scan/MRI scan according to RECISTcriteria
Measured: After liver transplantation and up 10 years after liver transplantation
Start of new treatment/Change of strategy
Time to start of new treatment
Measured: Immediately after liver transplatation to start of new treatment
Time to decrease in physical function and global health score
Quality of life measured by EORTC QLQ-C30),
Measured: Up to 10 years after liver transplantation
Liver transplant Complication
Number of Clavien-Dindo grad 3-5 complications
Measured: Up to 90 days after liver transplantation
Number of Participants Developing other Malignancies
Diagnosis of other malignancies
Measured: Up to 10 years after liver transplantation
Survival in relation to biological markers
CEA, CA 19-9 and Germline DNA analyses
Measured: After Liver Transplant until 10 years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jun 2020
- Primary completion31 May 2035 (estimated)
- Study completion31 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Smedman, MD, Oslo University Hospital
- Investigators
- Magnus Smedman, MD, Principal investigator, Oslo University HospitalSheraz Yaqub, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556214
- Sponsor's protocol ID
- TESLA trial
- Status last verified
- Apr 2023
- First submitted
- 30 Jun 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23.
PubMed 38258823
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)
- ClinicalTrials.gov ID
- NCT04556214
- Acronym / sponsor ID
- TESLA trial
- Conditions
- Intrahepatic Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2035 (estimated)
- Study completion
- 31 May 2035 (estimated)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant | Experimental | Procedure: Liver TransplantThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver TransplantLiver Transplant | Procedure or surgery | Liver Transplant |
Primary outcome
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
7 secondary outcomes
Overall Survival from time of relapse
Time frame: From time of relapse and until 36 months after inclusion
Disease free survival
Time frame: After liver transplantation and up 10 years after liver transplantation
Start of new treatment/Change of strategy
Time frame: 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
Liver transplant Complication
Time frame: Up to 90 days after liver transplantation
Number of Participants Developing other Malignancies
Time frame: Up to 10 years after liver transplantation
Survival in relation to biological markers
Time frame: After Liver Transplant until 10 years after liver transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 38258823Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Smedman, MD principal investigator
Oslo University Hospital
Sheraz Yaqub, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Transplant in people with Intrahepatic Cholangiocarcinoma, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Smedman, MD (23026600 ext. +47, torha@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From screening and until 36 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.