Table 2.
Summary of active phase 3 clinical trials of a combination of TACE and immune checkpoint inhibitor-based therapy
| Trial name (Registration No.) | Characteristics | Endpoint | ||
|---|---|---|---|---|
| arm | patient, n | primary | secondary | |
| EMERALD-1 [81] (NCT03778957) | A: TACE followed by durvalumab | 600 | PFS: arm A versus arm C by RECIST v1.1 | 1. PFS: arm B versus arm C |
| B: TACE followed by durvalumab plus Bevacizumab | 2. OS | |||
| C: TACE followed by placebo | 3. Health-related quality of life measures | |||
| 4. Safety | ||||
| LEAP-012 [82] (NCT04246177) | A: lenvatinib plus pembrolizumab plus TACE | 950 | OS and PFS by RECIST v1.1 | 1. PFS, ORR, DCR, DOR, and TTP by modified RECIST |
| B: placebo plus TACE | 2. ORR, DCR, DOR, and TTP by RECIST v1.1 | |||
| 3. Safety | ||||
| CheckMate 74W [83] (NCT04340193) | A: nivolumab plus ipilimumab plus TACE | 765 | 1. TTTP | 1. TTTP and OS: arm B versus arm C |
| B: nivolumab plus placebo plus TACE | 2. OS: arm A versus arm C | 2. Event-free survival | ||
| C: placebo plus TACE | 3. PFS | |||
| TALENTACE [84] (NCT04712643) | A: TACE plus atezolizumab plus bevacizumab | 342 | 1. Independent review committee-determined TACE-PFS (randomization to unTACEable progression, TACE failure/refractoriness, or death) | 1. Investigator-determined TACE-PFS |
| 2. OS | 2. Time to unTACEable progression, progression, MVI, EHS, and MVI/EHS | |||
| B: TACE alone | 3. ORR, DOR, patient-reported outcomes, AE | |||
AE, adverse events; CI, confidence interval; DCR, disease control rate; DOR, duration of response; EHS, extrahepatic spread; HR, hazard ratio; MVI, microvascular invasion; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TACE, transarterial chemoembolization TTP, time to progression; TTTP, time to TACE progression; RECIST, Response Evaluation Criteria in Solid Tumors.