Table 2.
TACE combination trials with sorafenib
| Trial | Ph3 Post-TACE | Ph2 SPACE | Ph3 TACE-2 | Ph2 TACTICS |
|---|---|---|---|---|
| Author | Kudo et al. [7], 2011 | Lencioni et al. [9], 2016 | Meyer et al. [11], 2017 | Kudo M et al. [14], 2018 |
| Child-Pugh class | A | A (no ascites) | A | A5–B7 |
| ECOG-PS | 0–1 | 0 | 0–1 | 0–1 |
| Tumor burden | ≤7 cm ≤10 tumors |
Unresectable multinodular | Not a candidate for resection or transplantation | ≤10 cm ≤10 tumors |
| TACE procedure | cTACE, on demand | DEB-TACE, scheduled | DEB-TACE, on demand | cTACE, on demand |
| Endpoint | TTP (5.4 months) | TTP (5.6 months) | PFS (8.5 months) | PFS (25.2 months) |
| Progression criteria | RECICL 2004 | mRECIST | RECIST 1.1 | UnTACEable progression/TACE failure New lesion: not PD |
| Sorafenib duration, weeks | 17.0 | 21.0 | 17.1 | 38.7 |
| Median follow-up, weeks | NA | 38.6 | 88.6 | 122.3 |
cTACE, conventional lipiodol TACE; RECICL, response evaluation criteria in the cancer of liver