TABLE 5.
Ongoing Clinical Trials of Immune Checkpoint Inhibition in Combination With Locoregional Therapy in Liver Cancer
| Intervention | Trial Type | Trial description | ClinicalTrials.gov Identifier |
|---|---|---|---|
| Immune checkpoint Inhibition plus locoregional therapy | |||
| HCC | |||
| Nivolumab (anti-PD-1) + Y90 | Phase 2, nonrandomized, open label, single center | Advanced HCC; Child-Pugh A (40 pts) | NCT03033446 |
| Phase 1/2, one arm, open label | Advanced HCC; Child-Pugh A or B (35 pts) | NCT02837029 | |
| Nivolumab (anti-PD-1) + SIRT | Phase 2, single arm, open label, multicenter | HCC candidates for locoregional therapy (40 pts) | NCT03380130 |
| Phase 2/3, randomized, two arm | Intermediate stage HCC; Child-Pugh B or C (522 pts) | NCT04268888 | |
| Nivolumab (anti-PD-1) + TACE | Phase 1, nonrandomized, open label | Advanced HCC; Child-Pugh A (14 pts) | NCT03143270 |
| Phase 2, single arm, open label | Intermediate stage HCC; Child-Pugh A (49 pts) | NCT03572582 | |
| Pembrolizumab (anti-PD-1) + RFA/MWA | Phase 2, one arm, open label | Early-stage HCC; Child-Pugh score ≤6 (30 pts) | NCT03753659 |
| Pembrolizumab (anti-PD-1) + SBRT | Phase 2, single arm, open label | Advanced HCC after treatment with sorafenib; Child-Pugh A (30 pts) | NCT03316872 |
| Pembrolizumab (anti-PD-1) + TACE | Phase 1b, one arm, open label | Unresectable HCC; Child-Pugh score < 7 (26 pts) | NCT03397654 |
| Sintilimab (anti-PD-1) + TACE ± MWA | Phase 1, single arm, open label | Unresectable HCC; BCLC stage B/C (45 pts) | NCT04220944 |
| Toriplimab (anti-PD-1) + RFA/MWA | Phase 1/2, randomized, open label | Unresectable HCC; Child-Pugh A or B (120 pts) | NCT03864211 |
| Durvalumab (anti-PD-L1) + TACE | Phase 3, randomized controlled, multicenter | Locoregional HCC; Child-Pugh A (600 pts) | NCT03778957 |
| Durvalumab (anti-PD-L1) + tremelimumab (anti-CTLA-4) + TAC/RFA | Phase 2, nonrandomized, open label | Unresectable, refractory HCC or BTC; Child-Pugh A/B (90 pts) | NCT02821754 |
| Phase 2, single arm, open label | Unresectable HCC or BTC; Child-Pugh A (70 pts) | NCT03482102 | |
| Phase 2, nonrandomized, open label | |||
| Intermediate stage of HCC (30 pts) | NCT03638141 | ||
| CCA | |||
| Pembrolizumab (anti-PD-1) + SBRT | Phase 2, randomized, open label | Unresectable, treatment-naïve ICC, eligible for radiotherapy; Child-Pugh A (184 pts) | NCT03898895 |
| Durvalumab (anti-PD-L1) + tremelimumab (anti-CTLA-4) + TACE/RFA/cryoablation | Phase 2, nonrandomized, open label | Unresectable, refractory HCC or BTC (90 pts) | NCT02821754 |
| Phase 2, single arm, open label | Unresectable HCC or BTC (70 pts) | NCT03482102 | |
Note: A www.ClinicalTrials.gov search was performed using the terms “liver cancer,” “hepatocellular carcinoma,” and “liver neoplasm” for HCC; “biliary tract cancer,” “cholangiocarcinoma,” “biliary carcinoma,” “bile duct,” or “biliary tract” for CCA; and “hepatobiliary malignant tumors” for both HCC and CCA. The search identified immunotherapy trials with a status of “Recruiting,” “Not yet recruiting,” “Active, not recruiting,” or “Enrolling by invitation,” and trials without the inclusion of a specific liver cancer cohort or without adequate information available were excluded. Search was updated as of March 30, 2020.
Abbreviations: MWA, microwave ablation; TACE, transarterial chemoembolization; SBRT, stereotactic body radiotherapy.