Table 3. Key ongoing phase III clinical trials for immunotherapy in hepatobiliary cancers.
| Disease | Setting | Phase/study size | Interventions | Status, estimated completion date | Study name & identifier |
|---|---|---|---|---|---|
| Hepatocellular carcinoma (HCC) | Untreated, locally advanced or metastatic† | Phase III, 480 | Atezolizumab + bevacizumab vs. sorafenib | Recruiting, June 2022 | NCT03434379 (IMBrave150) (56,57) |
| HCC | Systemically untreated, advanced† | Phase III, 1310 | Durvalumab + tremelimumab vs. durvalumab vs. sorafenib | Recruiting, June 2021 | NCT03298451 (HIMALAYA) (58,59) |
| HCC | Non-metastatic and non-curative, amenable to TACE‡ | Phase III, 600 | TACE + durvalumab vs. TACE + durvalumab + bevacizumab vs. TACE + placebo | Recruiting, November 2023 | NCT03778957 (EMERALD-1) (60) |
| HCC | Adjuvant after successfully completed curative therapy (resection or ablation)† | Phase III, 888 | Durvalumab + tremelimumab vs. durvalumab vs. placebo | Recruiting, June 2023 | NCT03847428 (EMERALD-2) (61) |
| HCC | Previously systemically treated advanced† | Phase III, 450 (Asian patients only) | Pembrolizumab (MK-3475) or placebo + best supportive care | Recruiting, January 2022 | NCT03062358 (KEYNOTE-394) (62) |
| HCC | First-line, advanced† | Phase III, 750 | Lenvatinib + pembrolizumab (MK-3475) vs. lenvatinib | Recruiting, July 2022 | NCT03713593 (LEAP-002) (63) |
| HCC | Adjuvant after successfully completed curative therapy (resection or ablation)† | Phase III, 530 | Nivolumab vs. placebo | Recruiting, June 2025 | NCT03383458 (CheckMate-9DX) (64) |
| Biliary tract cancers (BTCs) | Untreated, locally advanced or metastatic§ | Phase III, 390 | KN035 + gemcitabine + oxaliplatin vs. gemcitabine + oxaliplatin | Recruiting, June 2022 | NCT03478488 (65) |
†, Child Pugh A only; ‡, Child Pugh A or B7; §, Child Pugh A or B. TACE, transarterial chemoembolization.