Clinical trial NCT04874259: LT for Unresectable Colorectal Liver Metastasis
Official title: Effectiveness of Liver Transplantation for Unresectable Colorectal Liver Metastasis; Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Metastasis Colon Cancer
Keywords: colorectal cancer
liver metastasis
living donor liver transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Unlike hepatocellular carcinoma, liver transplantation in patients with liver metastasis from colorectal cancer is limited in only few centers. Previously, it was not generally implemented due to lack of organs and high recurrence rates after transplantation. However, due to progressive development in treatments, good results such as increased survival rates can be expected even in liver transplant patients with liver metastasis from colorectal cancer, which is known to have poor prognosis. Therefore, the purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

Detailed description: Surgical treatment offers a distinct survival benefit in liver metastasis of colorectal cancer (CRC LM). However, it has been estimated that only 40% of patients are candidates for curative liver resection. Liver transplantation can be considered as one of a treatment option, since all evident disease is removed during procedure. However, it is limited in only few centers due to lack of organs and high recurrence rates after transplantation.

Currently, with help of development in treatments, prognosis after LT in CRC LM is improving. Recent study of LT for CRC LM from Norway demonstrated a 5-year survival of 56%. In addition, cohort study and randomized controlled trials are ongoing in Germany and Canada. Therefore, it seems to be necessary to verify the effectiveness of liver transplantation for CRC LM and to verify it as an alternative treatment if there is no other treatment. The purpose of this study is to analyze the efficacy of liver transplantation as an alternative treatment for liver metastasis from colorectal cancer.

Potential participants will be evaluated for liver transplantation and must also have a willing, healthy living donor. Unresectable metastasis should be limited to the liver and stable without no other treatment such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation. The suitability of liver transplantation will be evaluated through a multidisciplinary assessment immediately before transplantation. Those participants who undergo liver transplantation will be followed for survival, disease-free survival, and recurrence for 3 years.

Eligibility criteria: Inclusion Criteria:

* Proven colorectal cancer liver metastases without no other treatment (such as immunotherapy, chemotherapy, surgical resection, and radiofrequency ablation)
* Metastasis isolated to liver
* Patients selected as a liver transplant recipient at a multidisciplinary meeting
* Paitents with a willing, healthy living donor
* Willing and able to provide written informed consent

Exclusion Criteria:

* Pregnant women
* Known history of human immunodeficiency virus (HIV) infection
* Patients with active peptic ulcer within 2 weeks of transplantation
* Persistent colorectal cancer after colon resection
* Hemodynamically unstable prior to liver transplantation
* Progression of LM at any timepoint prior to transplant surgery (assessed in a multidisciplinary meeting)

Primary outcomes:
measure: 1 year patient survival
timeFrame: 1 year
Secondary outcomes:
measure: 1 year disease-free survival
timeFrame: 1 year
measure: 3 year patient survival
timeFrame: 3 year
measure: 3 year disease-free survival
timeFrame: 3 year
measure: Recurrence
timeFrame: 3 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Nam-Joon Yi, Ph.D.
role: STUDY_CHAIR
References:
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citation: Glinka J, Ardiles V, Pekolj J, Mattera J, Sanchez Claria R, de Santibanes E, de Santibanes M. Liver transplantation for non-resectable colorectal liver metastasis: where we are and where we are going. Langenbecks Arch Surg. 2020 May;405(3):255-264. doi: 10.1007/s00423-020-01883-2. Epub 2020 Apr 24.
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