Table 7.
Clinical trials of TACE combination or with molecular targeted agents
| Post-TACE [131] | SPACE [132] | TACE-2 [133] | TACTICS [130] | ORIENTAL [134] | BRISK-TA [135] | |
|---|---|---|---|---|---|---|
| Phase | 3 | 2 | 3 | 2 | 3 | 3 |
| Design | RCT (vs. placebo) | RCT (vs. placebo) | RCT (vs. placebo) | RCT (open label) | RCT (vs. placebo) | RCT (vs. placebo) |
| Drug | Sorafenib | Sorafenib | Sorafenib | Sorafenib | Orantinib | Brivanib |
| Child-Pugh class | A | A (exclude ascites) | A | A5-B7 | A | A |
| ECOG-PS | 0–1 | 0 | 0–1 | 0–1 | 0–1 | 0–1 |
| BCLC stage tumor status | BCLC stage B | BCLC stage B | BCLC stage B | BCLC stage B | BCLC stage B | BCLC stage B |
| ≤7 cm, ≤10 nodules | Unresectable | Unresectable Untransplantable | ≤10 cm, <10 nodules | Unresectable | s≥5 cm ≥1 or ≥4 nodule (1 nodule ≥3 cm) | |
| TACE | Lp TACE | DEB-TACE | DEB-TACE | Lp TACE | Lp TACE | Any |
| TACE schedule | na | Scheduled | na | On demand | On demand | On demand |
| Primary endpoint | TTP | TTP | PFS | PFS/OS | OS | OS |
| Response evaluation | RECICL 2004 | mRECIST | RECIST 1.1 | RECICL 2009 (intrahepatic new lesion: not PD) | RECIST 1.1 | mRECIST |
| Final result | Negative | Negative (statistically positive as phase 2) | Negative | Positive | Negative | Negative |
TACE, transarterial chemoembolization; RCT, randomized controlled trial; BCLC, Barcelona Clinic Liver Cancer; PS, performance status; Lp, Lipiodol®; TTP, time to progression; PFS, progression-free survival; OS, overall survival; NA, not applicable.