Colorectal Liver Metastases

The purpose of this study is to construct and validate a multimodal survival prediction model by integrating 3D radiomics features derived from preoperative magnetic resonance imaging (MRI) with systemic clinical baseline indicators for patients with colorectal liver metastases (CRLM) after surgery. By combining micro-level radiomics signatures reflecting tumor micro-heterogeneity with macro-level clinical parameters (such as liver function and tumor biomarkers), the study aims to accurately evaluate individual post-operative prognostic risks. This quantitative tool will provide reliable decision support for clinicians to customize post-operative follow-up and personalized adjuvant treatment strategies.

Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents. These patients must have objective response to treatment (radiologic or pathologic response). The standard care for these patients is no postoperative treatment although benefit of reintroduction of FOLFIRI chemotherapy in good responders could be expected. This study is a National, multicenter, open-label randomized, 2-arm, phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy (experimental arm) vs no treatment (control arm) in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent. The primary endpoint of the study is 3-year disease free survival. Based on published data, 3-year DFS in control group (absence of postoperative treatment is 25%. Expected 3-year DFS in the experimental group is 40%. The study will randomize 254 patients (127 in the chemotherapy group and 127 in the no treatment group) in 30 french academic centers.

Patients whose colorectal cancer has spread to the liver, and whose liver metastases cannot be removed by surgery or destroyed by ablation, currently receive palliative chemotherapy in Germany. Fewer than one in ten of these patients survive five years. International studies have shown that replacing the whole liver by transplantation can achieve much longer survival in carefully selected patients, because removing the entire liver removes all of the tumour when the disease is confined to it. The TransMet trial reported five-year survival of 57% with transplantation plus chemotherapy, compared with 13% for chemotherapy alone. This approach is not yet available in German routine care, where liver transplantation for this indication is permitted only within a clinical study. GTO-001 will enrol approximately 260 adults aged 18 to 65 years with colorectal liver metastases that are confined to the liver, that cannot be removed or ablated, and that have remained stable or improved for at least six months on chemotherapy. Every participant is assessed by a newly established National Tumor Board for Transplant Oncology, which meets monthly, reviews the imaging and case independently of the local centre, and decides whether the patient may be listed for transplantation. Patients who are approved are listed with a study-specific priority status, continue their chemotherapy while they wait, and undergo a surgical inspection of the abdomen at the start of the transplant operation to confirm that the cancer has not spread outside the liver. Participants who are not listed, or in whom transplantation is not performed, remain in the study and are followed in the same way. The main question is how many patients are alive five years after transplantation. The study also measures how many of the patients assessed are eventually listed and transplanted, how many leave the waiting list because their disease progresses or becomes operable, survival after each of the treatments patients actually receive, how well the transplanted livers function, and complications after surgery. Because the study follows everyone who is assessed, it will also establish for the first time how many patients in Germany genuinely qualify for this treatment. Participants are followed for five years after transplantation; the study runs until 2036.

This study evaluates a surgical decision-support software designed to assist physicians in selecting the optimal surgical sequence for patients with colorectal cancer liver metastases. In this multicenter prospective simulation study, participating surgeons from multiple centers will review standardized clinical case scenarios. For each case, physicians will first make a surgical sequencing decision based on their own clinical judgment. They will then review the recommendation provided by the decision-support software and make a second decision if they choose to revise their initial plan. The study will assess whether the software influences clinical decision-making, including changes in surgical strategy, decision confidence, decision time, and agreement with software recommendations. Physician user experience will also be evaluated using standardized questionnaires, including system usability and cognitive workload scales. The goal of this study is to determine the clinical utility and usability of the decision-support software in improving surgical decision-making consistency and supporting clinical reasoning in colorectal liver metastases cases.

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.

The goal of this observational study is to develop an integrated clinical-molecular risk stratification to identifypatients who are at high risk of recurrence and who would benefit from adjuvant chemotherapy in patients with recectable colorectal liver metastases. The main question it aims to answer is: can the integration of multi-dimensional data-including ctDNA, driver gene profiles, and clinical factors-accurately identify postoperative patients at high risk of recurrence and guide personalized adjuvant therapy strategies?

The goal of this clinical trial is to learn if ivonescimab plus chemotherapy works to treat colorectal cancer liver metastases that cannot be completely removed. It will also learn about the safety of ivonescimab. The main questions it aims to answer are: Does ivonescimab plus chemotherapy raise the objective response rate? What medical problems do participants have when receiving ivonescimab plus chemotherapy? Participants will: Receive ivonescimab and chemotherapy every 3 weeks, no more than 8 cycles. Visit the clinic once every 2 cycles (6 weeks) for checkups and tests. Receive curative surgery, maintenance therapy, or discontinue study treatment according to the expert team's evaluation.

This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.

Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Laparoscopic ALPPS has recently been reported as a minimally invasive technique that reduces perioperative risks. This study aimed to assess the safety and feasibility of full laparoscopic ALPPS in patients with CRLM.

To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.