Table 1.

Overview of the reported trials of TACE combined with sorafenib therapy for unresectable HCC

Study	N	Clinicaltrials. gov ID	Study type	Patient selection	TACE drugs	TACE schedule	Sorafenib schedule	Outcome
Kudo et al 2011 [20]	458	NCT00494299	Multiple centers, randomized, controlled, double-blind, phase III	ECOG 0–1 Child-Pugh ≤7 PVT: no EHS: no Size: <7 cm	Epirubicin (n = 219), cisplatin (n = 89), doxorubicin (n = 49), combinations (n = 103)	No TACE after sorafenib initiation	Sequential, Start: 9.3 weeks following TACE	TTP (sor): 5.4 months OS: 29.7 months
Sansonno et al 2012 [21]	62	N/A	Single-center, randomized, controlled	ECOG 0–1 Child-Pugh A PVT: no EHS: no	Doxorubicin 30 mg, mitomycin C 10 mg	Repeated q 4–6 weeks on demand	Sequential, Start: 30 days after TACE	TTP: 9.2 months
Dufour et al 2010 [22]	14	NCT00478374	Single-center, single-arm, phase I	ECOG 0–1 Child Pugh ≤7 PVT: yes EHS: no Size: <10 cm	Doxorubicin 50 mg	Repeated q 4–6 weeks on demand	Continuous, Start: 1 week before TACE	OS, TTP, OR: N/A
Sieghart et al (SORATACE-1 Trial) 2012 [32]	15	NCT00768937	Single-center, single-arm, phase I/II	ECOG 0–2 Child Pugh ≤9 PVT: yes EHS: yes	According to tbili 25–75 mg/m2 (most 75 mg)	Repeated q4 weeks	Continuous, Start: 2 weeks before 1st TACE	OS: 10.6 months TTP: NA OR: 80% (RECIST)
Pawlik et al 2011 [24]	35	NCT00844883	Single-center, single-arm, Phase II	ECOG 0–1 Child-Pugh ≤ 7 PVT: yes EHS: yes	DEB-TACE	Repeated q 4–6 weeks on demand	Continuous, Start: 1 week before TACE	DC: 92% (EASL) and 100% (EASL)
Erhardt et al (SOCRATES Trial) 2011 [26]	45	NCT00618384	Multiple centers, single-arm, phase II	ECOG 0–2 Child-Pugh ≥8 PVT: no EHS: no	Doxorubicin 50 mg	Repeated q 6 weeks on demand	Interrupted, Start ≤14 days before TACE, interrupted 3 days before and 1 day after TACE	OS: 562 days TTP: 526 days OR: 78% (RECIST)
Cabrera et al 2011 [56]	47	N/A		ECOG 0–1 Child-Pugh A PVT: yes EHS: no	DEB-TACE with doxorubicin (85% patients) Y90 (15%, with PVT)	Repeated q 1–2 months on demand	Continuous, Start: 2–4 weeks before TACE	DC: 68% at 6 months
Chao Y et al (START trial) 2011 [27]	166	NCT00990860	Multiple centers, single-arm, phase II	BCLC B ECOG 0–1 Child-Pugh ≤ 7 PVT: yes EHS: no	Doxorubicin 30–60 mg	Repeated q 6–8 weeks on demand	Interrupted, Start: on day 4 after 1st TACE and interrupted 4 days before next TACE cycle restarted on day 4	OS: N/A TTP: 9 months OR: 53.8%
Park HJ et al (COTSUN Korea Trial) 2012 [28]	50	NCT00919009	Single-center, single-arm, phase II	ECOG 0–1 Child-Pugh ≤7 PVT: yes EHS: yes	Doxorubicin 30–60 mg	Repeated q 4–6 weeks on demand	Interrupted, Start: on day 3 after 1st TACE and stopped 1 day before next TACE	OS: N/A TTP: 5.1 months OR: 84% (RECIST)