Inclusion criteria for liver transplantation in patients with colorectal liver metastases: How to make the best selection?

Table 2 Exclusion criteria reported in the studies registered in ClinicalTrials.gov focused on liver transplantation for colorectal cancer liver metastases

NCT	Location	Criteria
Demographic parameters
NCT02215889	Oslo, Norway	Weight loss > 10% in the last 6 months; BMI > 30
NCT04870879	Padua, Italy	Weight loss > 10% in the last 6 months; BMI > 30
NCT03494946	Oslo, Norway	Weight loss > 10% in the last 6 months; BMI > 30
NCT01479608	Oslo, Norway	Weight loss > 10% in the last 6 months; BMI > 30
NCT04616495	Valencia, Spain	BMI ≥ 30; pregnancy at time of inclusion; 10% weight loss
NCT04865471	Padua, Italy	Weight loss > 10% in the last 6 months; BMI > 30; pregnancy or breastfeeding
NCT04161092	Gothenburg, Sweden	Weight loss > 10% in the last 6 months; pregnancy or breastfeeding
Biochemical markers
NCT04616495	Valencia, Spain	Creatinine clearance < 50 mL/minute
NCT02864485	Toronto, Canada	Renal dysfunction with creatinine clearance < 50 mL/minute
CEA
NCT03494946	Oslo, Norway	CEA > 80 ng/mL with 2 other negative prognostic factors
NCT04616495	Valencia, Spain	CEA > 80 ng/mL at time of enrolment
Tumor characteristics
NCT02215889	Oslo, Norway	Bone or CNS metastases; prior breast cancer or malignant melanoma
NCT05186116	Modena, Italy	Prior extrahepatic disease or primary tumor relapse
NCT05750329	RenJi Hospital, Shanghai, China	Extrahepatic tumor burden (except resectable lung metastases); macrovascular infiltration
NCT04870879	Padua, Italy	Prior extrahepatic metastases or local relapse
NCT03803436	Milan, Italy	Prior extrahepatic metastases or primary tumor relapse; extraperitoneal tumors
NCT05398380	Barcelona, Spain	Lesion > 5.5 cm; primary tumor recurrence; Lynch syndrome; BRAF/MSI tumors
NCT06069960	RenJi Hospital, Shanghai, China	Extrahepatic burden or large vessel invasion; lesion > 5.5 cm; BRAF/MSI
NCT04742621	NY, United States	Extrahepatic disease; MSI-H/dMMR or BRAF mutation; prior lung metastasectomy
NCT05185245	Bologna, Italy	Extrahepatic metastases; local recurrence
NCT03494946	Oslo, Norway	Local relapse; non-hepatic metastasis; thoracic/abdominal lymph nodes; lesion > 10 cm; > 5.5 cm with other risks
NCT01479608	Oslo, Norway	Extrahepatic metastases or local relapse
NCT04616495	Valencia, Spain	Extrahepatic metastases; lesion > 5 cm; BRAF mutation
NCT04161092	Gothenburg, Sweden	Extrahepatic disease; lesion > 10 cm; abdominal lymphadenopathy; BRAF mutation
Treatment history
NCT05186116	Modena, Italy	Disease progression
NCT05750329	RenJi Hospital, Shanghai, China	Tumor progression during chemotherapy
NCT03488953	Jena, Germany	Progression during chemotherapy
NCT05398380	Barcelona, Spain	Tumor recurrence in the last 12 months
NCT06069960	RenJi Hospital, Shanghai, China	Tumor progression during chemotherapy
NCT04874259	Seoul, Korea	Progression of liver metastases at any time point
NCT04616495	Valencia, Spain	No neoadjuvant chemotherapy
NCT01479608	Oslo, Norway	Not received standard CRC treatment
NCT02597348	Villejuif, France	Not received standard CRC treatment
Other criteria
NCT05186116	Modena, Italy	HIV, psychiatric disorders, active substance abuse, low compliance
NCT05750329	RenJi Hospital, Shanghai, China	AIDS, uncorrectable cardiopulmonary disease, anatomical abnormalities
NCT03803436	Milan, Italy	HIV, substance abuse
NCT05398380	Barcelona, Spain	Substance abuse, psychological/social issues, cardiac/pulmonary disease, infection
NCT06069960	RenJi Hospital, Shanghai, China	Cardiopulmonary disease, anatomical abnormalities, substance abuse, AIDS
NCT04874259	Seoul, Korea	Hemodynamic instability, peptic ulcer, HIV, pregnancy
NCT04616495	Valencia, Spain	HIV or HCV, pregnancy, general contraindication to LT, insurance issues
NCT02864485	Toronto, Canada	HIV, HBV/HCV, cardiac or pulmonary insufficiency, debilitating neuropathy
NCT02597348	Villejuif, France	Severe comorbidities, active infection, alcohol abuse, lack of compliance/support
NCT04865471	Padua, Italy	General contraindication to LT, refusal, pregnancy/breastfeeding
NCT04161092	Gothenburg, Sweden	Pregnancy, previous organ transplant

LT: Liver transplantation; BMI: Body mass index; CEA: Carcinoembryonic antigen; CNS: Central nervous system; MSI: Microsatellite instability; MSI-H: Microsatellite instability-high; dMMR: Mismatch repair-deficient; CRC: Colorectal cancer; HIV: Human immunodeficiency virus; AIDS: Acquired immune deficiency syndrome; HBV: Hepatitis B virus; HCV: Hepatitis C virus.