Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05186116
Study type Interventional
Source Azienda Ospedaliero-Universitaria di Modena
Contact
Status Recruiting
Phase N/A
Start date January 1, 2022
Completion date January 1, 2032

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04081168 - COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation N/A
Recruiting NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT03562234 - The CLiFF Study: Change in Liver Function and Fat in Pre-operative Chemotherapy for Colorectal Liver Metastases
Not yet recruiting NCT04874259 - LT for Unresectable Colorectal Liver Metastasis N/A
Recruiting NCT03732235 - TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer
Recruiting NCT04491929 - Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases
Enrolling by invitation NCT03444194 - Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study N/A
Recruiting NCT04595266 - Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease Phase 2
Recruiting NCT04701281 - Study of Intra-Arterial Oxaliplatin Plus Capecitabine to Treat Liver Metastases From Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04046445 - Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer Phase 1/Phase 2
Recruiting NCT03088150 - COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation N/A
Recruiting NCT05175092 - Living Donor Liver Transplantation for CRC Liver Metastases N/A
Not yet recruiting NCT04163887 - Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases N/A
Recruiting NCT04003792 - Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM. Phase 2
Recruiting NCT03981497 - Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms
Recruiting NCT04597710 - Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing
Recruiting NCT04714983 - DNX-2440 for Resectable Colorectal Liver Metastasis Phase 1
Completed NCT02954913 - Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases N/A
Not yet recruiting NCT05183776 - Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT N/A
Recruiting NCT04668872 - Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation