Table 2.
Ongoing clinical trials in patients with advanced hepatocellular carcinoma (HCC) according to inclusion criteria: macrovascular invasion (MVI) only (any phase) or with or without MVI (phase III)
| ClinicalTrials.gov identifier | Experimental treatment | Control arm | Phase | Setting |
|---|---|---|---|---|
| HCC with MVI only | ||||
| TACE | ||||
| NCT03007212 | TACE | Sorafenib | IV | 1st line |
| Radioembolization | ||||
| NCT01556282 | TheraSphere | II | ||
| NCT01887717 | TheraSphere | Sorafenib | III | 1st line |
| External radiotherapy | ||||
| NCT02571946 | Proton beam therapy | - | II | - |
| Combination therapy | ||||
| NCT01911000 | Radiotherapy and hyperthermia after TACE | - | II | 1st line |
| NCT03009461 | Sorafenib and HAIC | Sorafenib | II | 1st line |
| NCT02452853 | Hepatic resection and FOLFOX4 | - | II | 1st line |
| NCT02301091 | TACE and RFA | TACE alone | III | - |
| HCC with or without MVI | ||||
| Combination therapy | ||||
| NCT01126645 | SIRT+sorafenib (SORAMIC) | Sorafenib | III | 1st line |
| NCT01556490 | SIRT+sorafenib (STOP HCC) | Sorafenib | III | 1st line |
| NCT02562755 | Sorafenib+vaccinia virus-based immunotherapy | Sorafenib | III | 1st line |
| NCT02774187 | Sorafenib+HAIC | Sorafenib | III | 1st line |
| NCT01214343 | Sorafenib+low-dose cisplatin/fluorouracil HAIC | Sorafenib | III | 1st line |
| NCT01829035 | Sorafenib+TACE | Sorafenib | III | 1st line |
| NCT01730937 | Sorafenib+stereotactic body radiation therapy | Sorafenib | III | 1st line |
| Antiangiogenic agents | ||||
| NCT02435433 | Ramucirumab in patients with AFP ≥400 ng/mL | Placebo | III | 2nd line |
| NCT02329860 | Apatinib | Placebo | III | 2nd line |
| Cell-cycle inhibitors and antiproliferative agents | ||||
| NCT01908426 | Cabozantinib | Placebo | III | 2nd line |
| NCT01655693 | Doxorubicin transdrug (anthracyline) | Controlled vs. best supportive care | III | 2nd line |
| Immune modulators | ||||
| NCT02576509 | Nivolumab | Sorafenib | III | 1st line |
| NCT02702401 | Pembrolizumab | Placebo | III | 2nd line |
TACE, transarterial chemoembolization; HAIC, hepatic arterial infusion chemotherapy; RFA, radiofrequency ablation.