To investigate the application value of TACE combined with sorafenib in the treatment of primary liver cancer (PLC) from the perspective of clinical trials.

Four randomized controlled trials of TACE combined with sorafenib for PLC with the highest evidence level from 2010 to 2018 were selected globally, named Post-TACE, SPACE, TACE-2, TACTICS study respectively. Using the method of comparative description, the number of patients, tumor condition, liver function, general condition, TACE operation, duration of medication, primary endpoint, evaluation method and median follow-up time were analyzed. The clinical benefits of patients were further compared between different combinations of TACE with sorafenib to explore the optimal one and most eligible patients. In the literature review, the survival curve was delineated by Kaplan-Meier method. The survival status between two groups was analyzed by Cox's proportional hazards regression model.

Negative results were obtained in Post-TACE, SPACE and TACE-2 studies. TACTICS study showed that the median vascular invasion time, median extrahepatic metastasis time and TACE time interval in the TACE combined with sorafenib group were 31.3 months, 15.7 months and 21.1 weeks, respectively, significantly longer than 4.0 months, 6.9 months and 16.9 weeks in the single TACE group (HR=0.26, 0.21, 0.59; P=0.008, 0.006, 0.018).

From the perspective of clinical trials, TACE combined with sorafenib may prolong the progression-free survival of patients with unresectable early and middle stage PLC and play a role in stabilizing the tumor progression.