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LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis (LIVERMORE)

Primary Purpose

Colon Adenocarcinoma, Liver Metastasis Colon Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Living donor liver transplant

About this trial

This is an interventional treatment trial for Colon Adenocarcinoma focused on measuring LDLT, living donor, CRLM, transplant oncology

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18.
Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
Pathological classification of primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
Liver metastases not eligible for curative liver resection
Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete [CR] or partial response [PR] or standard disease [SD]) during second- line treatment for at least 4 months.
Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.
Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.

Exclusion Criteria:

Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
Prior extra hepatic metastatic disease or primary tumor local relapse.
Palliative resection of primary CRC tumor.
Disease progression
Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
Active intra-venous or alcohol abusers (patients may be eligible if abstention > 6 months is demonstrated)
Active HIV infection
Psychiatric disorders and patient low compliance
Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)

Sites / Locations

Azienda Ospedaliero Universitaria di ModenaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDLT recipients

Arm Description

Patients that undergo LDLT for CRLM in the study period

Outcomes

Primary Outcome Measures

Overall survival

Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Disease free survival

Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Secondary Outcome Measures

Graft survival

Incidence of retransplant in the LDLT group

Donor quality of life

Measure of Health-related quality of life (HRQOL) of donors using the a Short Form Health Survey 36 (SF-36). SF-36 is a multiplanar scale with scores ranging from 0 to 100 where zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Full Information

NCT ID

NCT05186116

First Posted

November 24, 2021

Last Updated

January 18, 2022

Sponsor

Azienda Ospedaliero-Universitaria di Modena

1. Study Identification

Unique Protocol Identification Number

NCT05186116

Brief Title

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

Acronym

LIVERMORE

Official Title

Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: "Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon"]

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

January 1, 2027 (Anticipated)

Study Completion Date

January 1, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliero-Universitaria di Modena

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life. Donor selection is performed according to the currently used Institutional and National standards and protocols.

Detailed Description

Liver Transplant (LT) is a feasible, safe and effective curative strategy for patients with unresectable colorectal liver metastases (CRLM), and several trials are currently active and in a recruitment phase to study its impact with both conventional donors and living donors (LDLT). As a matter of fact, in this setting living donors represent a helpful resource, thanks to the opportunity to schedule the LT at the timeliest conditions in terms of oncological response and patient's performance status. LDLT is a well-established procedure that is already offered to patients listed for LT at our Institution. Crucial requirement for study eligibility is the assessment of non-resectability of the presented liver metastases from colorectal cancer (CRC). Criteria for non-resectability of the liver-only CRC metastases eligible for the study should be assessed at the patient study entry, by the surgeon in charge together with the multidisciplinary team. Patients fulfilling the inclusion criteria of the study will undergo clinical, translational and regulatory steps. Briefly, the main procedures and requirements of the study can be summarized as follows: - Pre-transplant screening and waiting phase: Screening of patients with liver-limited CRC metastases potentially eligible to the study will be registered. The screening for general eligibility to liver transplantation will be conducted according to the existing Institutional protocol (called in Italian "PDTA", "Percorso Diagnostico Terapeutico Assistenziale"). During screening or waiting time periods, patients will continue planned chemotherapy treatment and will undergo blood tests (including CEA and Ca19.9), thoraco-abdominal CT scan and positron emission tomography (PET) scan (if needed) every 8 weeks. - Donors' screening: Screening of donors will be held according to the existing Institutional protocol for LDLT - Informed consent: Consent to the study will be signed after completion of the pre-LT screening, that is once co-morbidities and transplant eligibility will be ascertained on top of cancer conditions. In addition, patients will have to sign additional written informed consent prior to any study procedure. - Post-transplant follow-up: Following LDLT, standard institutional follow-up procedures will be performed and registered. Patient/graft condition and tumor status should be re-assessed at least every 4 months for the first 3 years, every 6 months for the rest of follow-up. Following donation standard institutional follow up will be performed on donors and registered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Adenocarcinoma, Liver Metastasis Colon Cancer

Keywords

LDLT, living donor, CRLM, transplant oncology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LDLT recipients

Arm Type

Experimental

Arm Description

Patients that undergo LDLT for CRLM in the study period

Intervention Type

Procedure

Intervention Name(s)

Living donor liver transplant

Intervention Description

Transplantation of part of the liver from a living donor

Primary Outcome Measure Information:

Title

Overall survival

Description

Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Time Frame

5 years

Title

Disease free survival

Description

Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Graft survival

Description

Incidence of retransplant in the LDLT group

Time Frame

5 years

Title

Donor quality of life

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

77 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18. Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma. Pathological classification of primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type. No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans. Liver metastases not eligible for curative liver resection Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete [CR] or partial response [PR] or standard disease [SD]) during second- line treatment for at least 4 months. Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant. Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2. Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations. Exclusion Criteria: Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome. Prior extra hepatic metastatic disease or primary tumor local relapse. Palliative resection of primary CRC tumor. Disease progression Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated). Active intra-venous or alcohol abusers (patients may be eligible if abstention > 6 months is demonstrated) Active HIV infection Psychiatric disorders and patient low compliance Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)

Facility Information:

Facility Name

Azienda Ospedaliero Universitaria di Modena

City

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Individual Site Status

Recruiting

Facility Contact: