An interventional study of Liver Transplantation and Liver Resection plus Ablation in Colorectal Liver Metastases, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Niguarda Hospital · Not applicable, Interventional, and Treatment
The TRANSECT trial is a prospective randomized study designed to evaluate the role of liver transplantation (LT) versus radical local treatment (hepatic resection and/or ablation) in patients with initially unresectable colorectal liver metastases (CRLM) converted to resectability after conversion therapy.
Liver metastases are the leading cause of mortality in colorectal cancer patients. Although hepatic resection combined with chemotherapy remains the standard curative-intent treatment, only a minority of patients are eligible for upfront surgery. Advances in modern conversion chemotherapy have substantially increased the proportion of patients who can subsequently undergo curative local treatment. However, liver resection after intensive chemotherapy is still associated with high rates of intrahepatic recurrence, risk of R1 resections, chemotherapy-induced liver injury, and the need for complex surgical procedures carrying considerable morbidity and mortality. In parallel, recent studies investigating LT for unresectable CRLM, including the TRANSMET trial, demonstrated highly promising oncological outcomes, with 5-year overall survival rates exceeding 50% in selected patients.
Based on these findings, the TRANSECT trial hypothesizes that LT may represent a more effective therapeutic strategy also in patients initially deemed unresectable but subsequently converted to resectability, by completely removing the hepatic metastatic niche.
TRANSECT is a single-center, randomized, open-label, proof-of-concept trial. Patients with liver-only CRLM initially assessed as unresectable by a dedicated multidisciplinary tumor board and subsequently converted to resectability after systemic therapy will be randomized to either LT or hepatic resection and/or ablation. The primary endpoint is 3-year intention-to-treat overall survival (OS). Secondary endpoints include perioperative morbidity and mortality, disease-free survival, treatment adherence, quality of life, and exploratory translational analyses including radiomics and circulating tumor DNA assessment.
A total of 70 patients (35 per arm) will be enrolled, with an estimated overall study duration of 5 years. TRANSECT represents the first randomized trial directly comparing LT and liver-directed surgery in patients with initially unresectable CRLM converted to resectability after systemic therapy, with the aim of redefining curative treatment strategies in this selected patient population.
Liver metastases represent the leading cause of mortality in patients with colorectal cancer. Although hepatic resection combined with systemic therapy remains the standard curative-intent treatment, a substantial proportion of patients present with disease that is initially unresectable at diagnosis.
Over the last years, advances in systemic chemotherapy and targeted therapies have significantly increased conversion-to-resectability rates in patients with initially unresectable colorectal liver metastases. As systemic therapies continue to improve, the number of patients achieving conversion from initially unresectable to potentially resectable disease is expected to progressively increase, making this clinical scenario increasingly relevant in daily practice.
However, surgical treatment after conversion therapy remains associated with important oncological and surgical challenges. A complete radiological response does not necessarily correspond to a complete pathological response, with the possible persistence of microscopic residual disease and a consequent risk of intrahepatic recurrence. In addition, prolonged exposure to chemotherapy may result in liver toxicity and impairment of the residual liver parenchyma, increasing the complexity of surgical strategies required to achieve radical resection and raising the risk of post-hepatectomy liver failure.
In this context, liver transplantation may represent an alternative therapeutic strategy that could overcome some of the limitations of resective surgery by completely replacing the metastatic liver and eradicating both macroscopic and microscopic residual disease.
This is a single-center, prospective, randomized, open-label, proof-of-concept study designed to compare liver transplantation with radical local treatment in patients with colorectal liver metastases initially unresectable and subsequently converted to resectability following systemic therapy.
Patient evaluation will be performed through a centralized multidisciplinary assessment involving hepatobiliary surgeons, transplant surgeons, oncologists, and radiologists with specific expertise in the management of colorectal liver metastases. All cases will be discussed within a multidisciplinary tumor board with centralized imaging review both at diagnosis and after systemic therapy in order to define initial unresectability and subsequent potential conversion to resectability in a standardized manner.
The definition of unresectability will consider anatomical, oncological, and functional criteria, including the possibility of achieving complete radical (R0) resection, the predicted future liver remnant volume, the need for complex surgical procedures, and the presence of factors associated with increased surgical or oncological risk. Similarly, conversion to resectability will be defined according to the possibility of achieving radical local treatment with curative intent following systemic therapy.
All patients will undergo centralized radiological reassessment with contrast-enhanced CT scan and MRI; FDG-PET imaging will be performed when clinically indicated. During systemic treatment, radiological reassessments will be performed periodically to monitor oncological response, confirm the absence of extrahepatic disease, and evaluate eligibility for radical local treatment.
Eligible patients will receive induction systemic therapy according to institutional clinical practice and, in case of conversion to resectability and maintenance of eligibility criteria, will be randomized in a 1:1 ratio to one of the two treatment strategies provided by the protocol:
In the liver transplantation arm, patients will continue systemic therapy until being listed for liver transplantation or until a transplantation date is established. If transplantation is not performed within two months after listing, patients will undergo repeat clinical, radiological, and biochemical reassessment, including imaging studies and tumor marker evaluation. In the presence of disease progression or increased tumor marker levels, patients may be temporarily suspended from the transplant waiting list and started on additional systemic therapy, followed by reassessment according to protocol-defined criteria. In the case of disease control, patients may be reconsidered for the transplant pathway. Otherwise, treatment will continue according to standard clinical practice.
In the surgical arm, radical local treatment will consist of hepatic resection with or without ablative procedures, according to multidisciplinary evaluation and the surgical strategy considered most appropriate to achieve complete disease control.
The study includes the evaluation of oncological, perioperative, and treatment adherence outcomes, in addition to exploratory translational analyses including radiomic characteristics, quality of life, and circulating biomarkers.
Patients will undergo clinical, laboratory, and radiological follow-up according to the study protocol and institutional clinical practice in order to monitor disease recurrence, oncological outcomes, and treatment safety.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria screening phase (before randomization):
Exclusion criteria:
Randomization inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will undergo liver transplantation after successful conversion to resectability following systemic therapy. In case of disease progression during the waiting period, patients may receive additional systemic therapy and be re-evaluated for transplant eligibility. In case of loss of eligibility, the patient will undergo the best standard of care (including resection). Post-transplant management will follow standard institutional protocols, including immunosuppressive therapy and oncologic follow-up.
Procedure: Liver Transplantation
Participants randomized to this arm will undergo radical local treatment consisting of hepatic resection with or without ablative techniques after successful conversion to resectability following systemic therapy. The surgical approach will be determined based on tumor characteristics and institutional standards, with the goal of achieving complete tumor removal (R0 resection). Perioperative management and postoperative care will follow standard clinical practice
Procedure: Liver Resection plus Ablation
Orthotopic liver transplantation performed in patients with colorectal liver metastases after successful conversion to resectability following systemic therapy. Eligibility for transplantation is confirmed through multidisciplinary evaluation and restaging. Patients continue systemic therapy after randomization until listing for transplantation or until the date of the procedure is established. Postoperative management includes standard immunosuppressive therapy and oncologic follow-up according to institutional protocols
Liver resection with or without ablative techniques in patients with colorectal liver metastases after successful conversion to resectability following systemic therapy. Patients continue systemic therapy after randomization until the surgical procedure is performed, according to protocol. The surgical strategy is determined by a multidisciplinary team with the aim of achieving complete tumor removal (R0 resection). Perioperative and postoperative management follow standard institutional practice
Overall Survival (OS)
Overall survival will be measured from the date of randomization to death from any cause and analyzed according to the intention-to-treat principle.
Time frame: 3 years
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from the date of treatment (liver transplantation or hepatic resection ± ablation) to the date of tumor recurrence or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Perioperative Morbidity
Assessment of postoperative complications occurring within 90 days after liver transplantation or hepatic resection + ablation, graded according to standard clinical classifications.
Time frame: 90 days after treatment
Perioperative Mortality
All-cause mortality occurring within 90 days after liver transplantation or hepatic resection + ablation
Time frame: 90 days after treatment
Plan to share: Yes — After request to the PI and evaluation of the research intent.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's planned 36 months is below that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
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