Table 1 Five trials recruiting patients with colorectal liver metastases for liver transplantation
RAPID | SECA-II | LIVER-T(W)O-HEAL | |||
|---|---|---|---|---|---|
NCT02215889 | NCT01479608 | NCT02597348 | NCT02864485 | NCT03488953 | |
Country | Norway | Norway | France | Canada | Germany |
Center(s) | Oslo | Oslo | Paris, Paul-Brousse- Hospital | Toronto | Jena and Tübingen |
Start | 6/2014 | 2011 | 10/2015 | 8/2016 | 3/2018 |
State | Recruiting | Recruiting | Recruiting | Recruiting | Recruiting |
Planned number of included patients | 20 | 25 | 90 | 20 | 40 |
Inclusion criteria | More than 8 weeks of systemic therapy More than 12 months after resection of the primary tumor. | More than 6 weeks of systemic therapy More than 12 months after resection of the primary tumor. Metachronous metastasis > 12 months after resection of the primary tumor Initial lymph node state: pN0 CEA: < 100 | At least “stable disease” after 3 months of systemic therapy. More than 12 months after resection of the primary tumor. BRAF wild-type | At least “stable disease” during systemic therapy. State of the primary tumor: <pT3, N1 More than 6 months after resection of the primary tumor. BRAF wild-type | At least “stable disease” after 8 weeks of systemic therapy. State of the primary tumor: <pT3, N1 |
Mode of transplantation | Deceased donation. Left lateral split (segment II/III). Two-stage hepatectomy. | Deceased donation, whole organ | Deceased donation, whole organ | Living donation, right liver lobe | Living donation Left lateral split (segment II/III) Two-stage hepatectomy |
Primary endpoint | Overall survival, recurrence-free survival, technical feasibility. | Overall survival, recurrence-free survival | Overall survival, recurrence-free survival | Overall survival, recurrence-free survival | Overall survival, recurrence-free survival, technical feasibility |