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Living Donor Liver TransplantationLIVINCANCT06539377

Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma

A study testing Living donor liver transplantation in people with Living Donor Liver Transplantation and Liver Transplantation, run by Jena University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Living donor liver transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 1 Oct 2031
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

  • non-resectable intrahepatic cholangiocarcinoma (either for localization / distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis / cirrhosis)
  • biopsy proven grading G1 / G2
  • in case of mixed hepatocellular carcinoma / cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 / G2
  • response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory
  • peritoneal carcinosis / extrahepatic spread ruled out in PET-CT and/or MRT/CT and, at latest, during exploration
  • age ≥ 18
Show all 9Show fewer
  • blood-group compatible living donor available
  • in female patients: negative pregnancy test
  • written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)

Who cannot join

  • extrahepatic tumor/metastases
  • G3 tumors
  • progress under neoadjuvant treatment according to the RECIST-criteria
  • pregnancy or breastfeeding
  • patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
  • general contraindications for liver transplantation

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Falk Rauchfuss, Prof contact

0049 3641 9 322695

falk.rauchfuss@med.uni-jena.de

About this study

Official title: Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma

This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication "non-resectable intrahepatic cholangiocarcinoma" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).

Read the detailed description

Intrahepatic cholangiocarcinoma (iCCA) is classified among primary liver tumors and has demonstrated a consistently increasing incidence in recent years. Due to the poor long-term survival rates reported in older studies, liver transplantation continues to be a contraindication in the curative treatment of iCCA. The persistent shortage of organs also necessitates that each new indication for transplantation be carefully evaluated and critically scrutinized. Currently, partial resection remains the preferred treatment modality, although at diagnosis, only approximately 20% of cases are amenable to this approach. Post-partial resection, the five-year survival rate is observed to be between 20-34%. In cases of irresectability, palliative chemotherapy often remains the only option, typically associated with a poor prognosis. Numerous studies have demonstrated that long-term outcomes following liver transplantation for iCCA have evolved and improved over the years. In a meta-analysis by Ziogas et al., data from a total of 18 studies (involving 355 patients) and one registry study (385 patients) were analyzed. The pooled 1-, 3-, and 5-year survival rates were 75%, 56%, and 42%, respectively. Meanwhile, the pooled 1-, 3-, and 5-year recurrence-free survival rates were 70%, 49%, and 38%, with an overall recurrence rate of 43%. A potential reason for this marked improvement may be attributed to the introduction of neoadjuvant therapy. Studies by Hu et al. and Lunsford et al. have demonstrated that the utilization of neoadjuvant therapy is associated with significantly improved survival outcomes. The study aims to conduct a prospective, non-randomized study (LIVINCA) to further explore the effects of living-donor liver transplantation in the treatment of unresectable neoadjuvant treated (chemotherapy AND selective internal radiotherapy) intrahepatic cholangiocarcinoma.

Being tested
Living donor liver transplantation
Keywords
intrahepatic cholangiocarcinoma, living donor liver transplantation, neoadjuvant therapy, SIRT
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living donor liver transplantationProcedure or surgery

    Liver transplantation from living donor donation (SII/III as left-lateral donation during a "two stage"-procedure or left lobe donation or right lobe donation) in patients with unresectable intrahepatic cholangiocarcinoma.

Study groups in NCT06539377
Study groupRoleWhat they receive
Living donor liver transplantationExperimentalThe evaluation tests prior the transplantation will be performed following the standard protocol for the evaluation of a waiting list applicants prior liver transplantation. The aim of this procedure is to rule out any significant co-morbidities (e.g. cardiologic diseases, other malignancies) which would preclude liver transplantation. After successful evaluation of the recipient and waiting list registration with Eurotransplant, the AB0-compatible donor will be evaluated as well according to a center-specific protocol. For a local control of the tumor, an additional local-ablative therapy (SIRT) is mandatory.
Receives: Procedure: Living donor liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Five year overall survival

    Survival from time of transplantation to time of death or last follow up

    Measured: Five years

Secondary outcomes (2)

  1. Recurrence-free survival

    Survival from time of transplantation to time of death or first evidence of recurrence to disease

    Measured: Five years

  2. Donor and Recipient morbidity

    Donor and Recipient morbidity (both according to the Clavien-Dindo classification)

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion1 Oct 2031 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Curative treatment of unresectable intrahepatic cholangiocarcinoma via living donor donation and one- or two-staged hepatectomy
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539377
Sponsor's protocol ID
2024-3430-BO
Acronym
LIVINCA
Status last verified
Aug 2024
First submitted
30 Jul 2024
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goldaracena N, Gorgen A, Sapisochin G. Current status of liver transplantation for cholangiocarcinoma. Liver Transpl. 2018 Feb;24(2):294-303. doi: 10.1002/lt.24955.

    PubMed 29024405

  • Ziogas IA, Giannis D, Economopoulos KP, Hayat MH, Montenovo MI, Matsuoka LK, Alexopoulos SP. Liver Transplantation for Intrahepatic Cholangiocarcinoma: A Meta-analysis and Meta-regression of Survival Rates. Transplantation. 2021 Oct 1;105(10):2263-2271. doi: 10.1097/TP.0000000000003539.

    PubMed 33196623

  • Chan KM, Tsai CY, Yeh CN, Yeh TS, Lee WC, Jan YY, Chen MF. Characterization of intrahepatic cholangiocarcinoma after curative resection: outcome, prognostic factor, and recurrence. BMC Gastroenterol. 2018 Dec 4;18(1):180. doi: 10.1186/s12876-018-0912-x.

    PubMed 30514231

  • Lunsford KE, Javle M, Heyne K, Shroff RT, Abdel-Wahab R, Gupta N, Mobley CM, Saharia A, Victor DW, Nguyen DT, Graviss EA, Kaseb AO, McFadden RS, Aloia TA, Conrad C, Li XC, Monsour HP, Gaber AO, Vauthey JN, Ghobrial RM; Methodist-MD Anderson Joint Cholangiocarcinoma Collaborative Committee (MMAJCCC). Liver transplantation for locally advanced intrahepatic cholangiocarcinoma treated with neoadjuvant therapy: a prospective case-series. Lancet Gastroenterol Hepatol. 2018 May;3(5):337-348. doi: 10.1016/S2468-1253(18)30045-1. Epub 2018 Mar 13.

    PubMed 29548617

  • McMillan RR, Javle M, Kodali S, Saharia A, Mobley C, Heyne K, Hobeika MJ, Lunsford KE, Victor DW 3rd, Shetty A, McFadden RS, Abdelrahim M, Kaseb A, Divatia M, Yu N, Nolte Fong J, Moore LW, Nguyen DT, Graviss EA, Gaber AO, Vauthey JN, Ghobrial RM. Survival following liver transplantation for locally advanced, unresectable intrahepatic cholangiocarcinoma. Am J Transplant. 2022 Mar;22(3):823-832. doi: 10.1111/ajt.16906. Epub 2021 Dec 27.

    PubMed 34856069

Questions about this trial

What is this clinical trial studying?

A study testing Living donor liver transplantation in people with Living Donor Liver Transplantation and Liver Transplantation, run by Jena University Hospital.

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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Falk Rauchfuss, Prof (0049 3641 9 322695, falk.rauchfuss@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Five year overall survival (time frame: Five years). 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 NCT06539377, which also lists 5 linked publications.

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 6 Aug 2024.

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