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NCT Number: NCT05185245

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

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

Recruiting

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Key information

Conditions

Liver Metastasis Colon Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Matteo Cescon, M.D.

CONTACT

[email protected]

+390512144785

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Liver Transplantation

Procedure

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Primary outcomes

  1. Overall Survival

    Time frame: 5 years

Secondary outcomes

  1. Disease-Free Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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