Table 2.
Randomized phase II, phase III clinical trials of early/intermediate stage HCC
Target population | Design | Trial name | Result | Presentation | Publication | First author | |
---|---|---|---|---|---|---|---|
Early | |||||||
Adjuvant (prevention of recurrence) | 1 | Vitamin K2 vs. placebo | Negative | Hepatology 2011 | Yoshida H | ||
2 | Peretinoin vs. placebo | NIK-333 | Negative | ASCO 2010 | JG 2014 | Okita K | |
3 | Sorafenib vs. placebo | STORM | Negative | ASCO 2014 | Lancet-O 2015 | Bruix J | |
4 | Peretinoin vs. placebo | NIK-333/K-333 | Negative | ||||
5 | Nivolumab vs. placebo | CheckMate 9DX | Ongoing | ||||
6 | Durvalumab ±bevacizumab vs. placebo | EMERALD-2 | Ongoing | ||||
Improvement of RFA | 1 | RFA ± LTLD | HEAT | Negative | ILCA 2013 | CCR 2017 | Tak WY |
2 | RFA ± LTLD | OPTIMA | |||||
Intermediate | |||||||
Improvement of TACE | 1 | TACE ± sorafenib | Post-TACE | Negative | ASCO-GI 2010 | EJC 2011 | Kudo M |
2 | TACE ± sorafenib | SPACE (Ph II) | Negative | ASCO-GI 2012 | J Hepatol 2016 | Lencioni R | |
3 | TACE ± brivanib | BRISK-TA | Negative | ILCA 2013 | Hepatol 2014 | Kudo M | |
4 | TACE ± orantinib | ORIENTAL | Negative | EASL 2015 | Lancet GH 2017 | Kudo M | |
5 | TACE ± sorafenib | TACE-2 | Negative | ASCO 2016 | Lancet GH 2017 | Meyer T | |
6 | TACE ± sorafenib | TACTICS (Ph II) | Positive | ASCO-GI 2018 | Kudo M |
Red, positive trial; blue, ongoing trials; black, negative trials; LTLD, lyso-thermosensitive liposomal doxorubicin.