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RecruitingNCT05185245Updated Jan 11, 2022

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

An interventional study of Liver Transplantation in Liver Metastasis Colon Cancer and Colorectal Cancer, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 73 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Apr 2021, registered Dec 2021).
  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 73 Years
Sex
All
01

Study summary

The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.

Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.

Type of different transplantations proposed are as follows:

  1. Whole liver graft or partial liver (split) from a deceased donor
  2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
  3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
  4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
  5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
  6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.

In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome

02

Conditions studied

  • Liver Metastasis Colon Cancer
  • Colorectal Cancer

Keywords

  • liver transplantation
  • non-resectable colorectal liver metastasis
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 20 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 509 studies on the registry; 285 are open to participants now.

Browse IRCCS Azienda Ospedaliero-Universitaria di Bologna studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 73 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
  • Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
  • No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
  • No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
  • Good performance status Eastern Cooperative Oncology Group 0 or 1
  • Neutrophils > 1.000
  • Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
  • Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
  • Written informed consent
  • No other contraindications to liver transplantation

Exclusion criteria

Exclusion Criteria:

  • Presence of other malignancies
  • Local recurrence of primary tumor
  • Extra-hepatic metastatic disease
  • Patients who did not receive any neoadjuvant or adjuvant therapy
  • Palliative resection of primary tumor
  • Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Liver Transplantation

    Procedure: Liver Transplantation

Interventions

  • ProcedureLiver Transplantation

    Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: 5 years

Secondary outcomes

  1. Disease-Free Survival

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    Bologna, 40138, Italy
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Mar 2025, 47 months after the start.

Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 47 months is above that.

Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2021
First posted
Jan 11, 2022
StartActual
Apr 1, 2021
Primary completionEst.
Mar 30, 2025
CompletionEst.
Mar 30, 2030
Last update
Jan 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05185245
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Apr 1, 2021
Primary completion
Mar 30, 2025 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Jan 11, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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