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Page 8 of 15 Li et al. Hepatoma Res. 2026;12:36

Table 2. Key design features and outcomes of phase II/III trials evaluating TACE-based combination therapies in HCC
Trial name Key population Treatment arms Sequence & interval Primary endpoint
(Phase) & outcome
Systemic-first: sorafenib TTP: 169 vs. 166
SPACE BCLC B; DEB-TACE plus sorafenib vs. initiated 3-7 day before the days (HR = 0.80, P
(Phase II) [52] Child-Pugh A DEB-TACE plus placebo
first TACE procedure = 0.07)
PFS: 7.8 vs. 7.5
Unresectable HCC; months (HR = 0.99,
Child-Pugh A; Systemic-first: sorafenib
TACE-2 DEB-TACE plus sorafenib vs. P = 0.94);
(Phase III) [53] ECOG PS ≤ 1; DEB-TACE plus placebo initiated 2-5 weeks before the OS: 19.5 vs. 18.4
Patent main portal vein; first TACE procedure months (HR = 0.91,
No extrahepatic spread
P = 0.57)
PFS: 22.8 vs. 13.5
months (HR = 0.66,
Unresectable HCC; Systemic-first: sorafenib
TACTICS cTACE plus sorafenib vs. P = 0.020);
(Phase II) [54] Child-Pugh A/B7; cTACE alone initiated 2-3 weeks before the OS: 36.2 vs. 30.8
ECOG PS 0-1 first TACE procedure
months (HR = 0.86,
P = 0.400)
PFS: 7.1 vs. 5.2
BCLC B/C; months (HR =
DEB-DEB-TACE-apatinib Child-Pugh A/B; DEB-TACE plus apatinib vs. TACE-first: apatinib initiated 0.564, P <​ 0.001);
(Phase III) [55] ECOG PS 0-1; DEB-TACE alone 3-5 days after DEB-TACE OS: 23.3 vs. 18.9
Vascular invasion allowed months (HR =
0.526, P <​ 0.001)
PFS: 10.6 vs. 6.4
months (HR = 0.43,
Systemic-first: lenvatinib
LAUNCH Advanced HCC; Child- TACE plus lenvatinib vs. initiated 1 day before the first P <​ 0.001);
(Phase III) [56] Pugh A lenvatinib OS: 17.8 vs. 11.5
TACE procedure
months (HR = 0.45,
P <​ 0.001)
TACE-first: durvalumab
BCLC A-C; TACE plus durvalumab plus initiated 1 week after the first PFS: 15.0 vs. 8.2
EMERALD-1 Child-Pugh A-B7; bevacizumab vs. TACE plus TACE procedure; bevacizumab months (HR = 0.77,
(Phase III) [12] ECOG PS 0-1; durvalumab vs. TACE plus initiated ≥ 2 weeks after P = 0.032);
No extrahepatic spread placebo completion of all planned OS: immature
TACE procedures
PFS: 14.6 vs. 10.0
Non-metastatic HCC; Systemic-first: lenvatinib plus months (HR = 0.66,
Child-Pugh A; TACE plus lenvatinib plus
LEAP-012 pembrolizumab initiated 2-4 P = 0.0002);
(Phase III) [13] ECOG PS 0-1; pembrolizumab vs. TACE plus weeks before the first TACE 24-month OS: 75%
Extreme tumor burden dual placebo procedure vs. 69% (HR = 0.80,
excluded
P = 0.087)
TACE-PFS: 11.3 vs.
Intermediate-to-high TACE-first: atezolizumab plus 7.0 months (HR =
TALENTACE tumor burden; TACE plus atezolizumab and bevacizumab initiated 2 to 8 0.71, P = 0.009);
(Phase III; preliminary Child-Pugh A; bevacizumab vs. TACE weeks after the first TACE OS: 34.5 vs. 35.4
conference data) [14] Mainly BCLC B, selected procedure months (HR = 0.96,
BCLC C/Vp1-2
P > 0.05)
Composite PFS: 10.8
Unresectable HCC; months vs. 3.2
Child-Pugh A; TACE plus camrelizumab and TACE-first: systemic therapy months (HR = 0.34,
CAP-ACE ECOG PS 0-1; rivoceranib/apatinib vs. TACE initiated within 2 weeks after P <​ 0.001);
(Phase II) [15]
No extrahepatic alone the first TACE procedure OS: 24.0 months vs.
metastasis 21.5 months (HR =
0.87, P > 0.05)
BCLC: Barcelona Clinic Liver Cancer; cTACE: conventional transarterial chemoembolization; DEB-TACE: drug-eluting bead transarterial
chemoembolization; ECOG PS: Eastern Cooperative Oncology Group performance status; HCC: hepatocellular carcinoma; HR: hazard ratio; OS:
overall survival; PFS: progression-free survival; RECICL: Response Evaluation Criteria in Cancer of the Liver; TACE: transarterial chemoembolization;
TACE-PFS: TACE-progression-free survival; TTP: time to progression.

approximately 26% had stage A disease, about 98% had Child-Pugh class A liver function, and nearly half
were beyond the up-to-seven criteria. This broad eligibility enhanced external validity but also complicated
the interpretation of OS by introducing heterogeneity in tumor burden, disease stage, TACE suitability, and
subsequent treatment pathways.