Chemotherapy for advanced hepatocellular carcinoma in the sorafenib age

Table 4 Clinical trials for evaluating the effect of transcatheter arterial chemoembolization with sorafenib in intermediate stage of hepatocellular carcinoma

Ref.	Acronym (NCT number)	Reported year	Trial phase	Study design	n	TACE	Outcomes
Pawlik et al[56]	-	2011	II	Single-arm (TACE plus sorafenib)	33	DEB/scheduled	Disease control rate = 100%, per lesion. Objective response = 58%, per lesion
Park et al[57]	-	2012	II	Single-arm (TACE plus sorafenib)	50	Conventional1/on demand	Median TTP = 7.1 mo
							6-mo PFS rate = 52%
Kudo et al[59]	Post TACE study	2011	III	TACE plus sorafenib vs TACE plus placebo	458	Conventional1/1 or 2 sessions	Median TTP = 5.4 (sorafenib)/3.7 (placebo) mo. HR [sorafenib] = 0.87; 95%CI: 0.70-1.09; P = 0.252
Lencioni et al[58]	SPACE	2012	II	TACE plus sorafenib vs TACE plus placebo	307	DEB/scheduled	Median TTP = 169 (sorafenib)/166 (placebo) d. HR [sorafenib] = 0.79; 95%CI: 0.588-1.080; P = 0.072
Kudo et al2	TACTICS (NCT01217034)	Currently recruiting participants	II	TACE plus sorafenib vs TACE alone	2283	Conventional1/on demand	Time to untreatable progression4
Meyer et al2	CRUK-TACE-2 (NCT01324076)	Currently recruiting participants	III	TACE plus sorafenib vs TACE plus placebo	4123	DEB/1 session	PFS4
Kauh et al2	(NCT01004978)	Currently recruiting participants	III	TACE plus sorafenib vs TACE plus placebo	4003	Conventional1 or DEB/scheduled	PFS4

¹Conventional TACE indicated transcatheter arterial chemoembolization with gelatin foam and lipiodol;

²The information of the trial can be accessed at ClinicalTrials.gov;

³Estimated Enrollment;

⁴Primary Outcome Measures. DBE: Drug-eluting beads; NCT: National clinical trial; PFS: Progression-free survival; TACE: Transcatheter arterial chemoembolization; TTP: Time to progression.