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New treatment option for Colon Adenocarcinoma
Official title LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
ClinicalTrials.gov ID: NCT05186116
What this study is testing
- What it's testing
- This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 77
You may be able to join if
- Age ≥18.
- Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
- Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component \>50%, confirmed R0...
- 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
You likely can't join if
- 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...
- Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated)
See the full eligibility criteria
- Age ≥18.
- Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
- Pathological classification of primary tumor as pT1-3, 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...
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Modena, MO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 77 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Modena, MO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.