Background: The evidence of transcatheter arterial chemoembolization (TACE) plus tyrosine kinase inhibitor and immune checkpoint inhibitor in unresectable hepatocellular carcinoma (HCC) was limited. This study aimed to evaluate the role of TACE plus apatinib (TACE + A) and TACE combined with apatinib plus camrelizumab (TACE + AC) in patients with unresectable HCC. Methods: This study retrospectively reviewed patients with unresectable HCC who received TACE + A or TACE + AC in 20 centers of China from January 1, 2019 to June 31, 2021. Propensity score matching (PSM) at 1:1 was performed to reduce bias. Treatment-related adverse events (TRAEs), overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were collected. Results: A total of 960 eligible patients with HCC were included in the final analysis. After PSM, there were 449 patients in each group, and the baseline characteristics were balanced between two groups. At data cutoff, the median follow-up time was 16.3 (range: 11.9–21.4) months. After PSM, the TACE + AC group showed longer median OS (24.5 vs 18.0 months, p < 0.001) and PFS (10.8 vs 7.7 months, p < 0.001) than the TACE + A group; the ORR (49.9% vs 42.5%, p = 0.002) and DCR (88.4% vs 84.0%, p = 0.003) of the TACE + AC group were also higher than those in the TACE + A group. Fever, pain, hypertension and hand-foot syndrome were the more common TRAEs in two groups. Conclusions: Both TACE plus apatinib and TACE combined with apatinib plus camrelizumab were feasible in patients with unresectable HCC, with manageable safety profiles. Moreover, TACE combined with apatinib plus camrelizumab showed additional benefit.

This randomized, prospective, multicenter (12 centers in China) phase III trial (Chinese Clinical Trial Registry #ChiCTR2000041170) compared drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carcinoma (uHCC). Progression-free survival (PFS) was the primary endpoint. Overall survival (OS), mRECIST-based objective response rates (ORR) and disease control rates (DCR), and treatment-related adverse events (TRAEs) were secondary endpoints. Totally 243 cases were randomized, with 122 and 121 in the DEB-TACE + apatinib and DEB-TACE groups, respectively. Cases administered DEB-TACE + apatinib displayed markedly improved median PFS (7.1 months [95%CI 6.6–8.3] vs. 5.2 months [95%CI 5.0–5.9]) and OS (23.3 months [95%CI 20.7–29.6] vs. 18.9 months [95%CI 17.9–20.1] compared with those treated with DEB-TACE (both p < 0.001). Additionally, patients administered DEB-TACE + apatinib had elevated ORR (56.6% vs. 38.8%) and DCR (89.3% vs. 80.2%) versus the DEB-TACE group (both p < 0.001). Majority of TRAEs were mild and manageable. Regarding DEB-TACE-related TRAEs, the rates of hepatic artery thinning and spasms were elevated during the second DEB-TACE in cases administered DEB-TACE + apatinib vs. DEB-TACE. The commonest apatinib-related TRAEs in the DEB-TACE + apatinib group included hypertension, hand-foot syndrome, fatigue, and diarrhea. In conclusion, DEB-TACE plus apatinib demonstrates superior PFS versus DEB-TACE monotherapy in uHCC cases, maintaining a favorable safety profile with similar occurrences of AEs.

Purpose: CalliSpheres^® microspheres (CSM) are the first drug-eluting beads (DEB) developed in China. This study aimed to compare treatment response, survival, and safety profiles between DEB transarterial chemoembolization (DEB-TACE) with CSM and conventional TACE (cTACE) in huge hepatocellular carcinoma (HCC) patients.Methods: A total of 71 patients with huge HCC who underwent DEB-TACE or cTACE were consecutively enrolled in this retrospective cohort study. Treatment response was assessed at first month (M1), third month (M3), and sixth month (M6) after TACE therapy; progression-free survival (PFS) and overall survival (OS) were evaluated; liver function indexes were recorded before TACE operation (M0), at first week (W1), M1 and M6 after TACE therapy; adverse events which occurred after TACE operation were recorded.Results: DEB-TACE presented with higher objective response rate (60.0% vs. 29.7%, p < 0.05) and disease control rate (86.7% vs. 59.4%, p < 0.05) compared with cTACE at M3. Regarding survival profiles, PFS [median: 3.3 months (95% CI: 2.8–3.7) vs. 2.1 months (95% CI: 1.7–2.5)] as well as OS [median: 7.8 months (95% CI: 4.6–11.0) vs. 5.7 months (95% CI: 5.0–6.3)] were longer in DEB-TACE group compared with cTACE group (both p < 0.01). Multivariate Cox’s regression further illustrated that DEB-TACE vs. cTACE was an independent protective factor for PFS and OS (both p < 0.01). As for safety profiles, patients’ liver function injury was reduced in the DEB-TACE group compared with the cTACE group. The incidence of fever was lower, and CINV was less severe in the DEB-TACE group compared with the cTACE group (both p < 0.05), while no difference in occurrence of liver abscess, increase of ascites, or moderate pain between two groups was observed.Conclusion: DEB-TACE with CSM presents with better treatment response, survival profiles, as well as safety profiles compared with cTACE in treatment for huge HCC patients.

Limited studies have reported the impact of drug-eluting bead transarterial chemoembolization (DEB-TACE) on hepatic fibrosis in hepatocellular carcinoma (HCC). This study evaluated multiple hepatic...

E16204 Background: To determine the safety and efficacy of transcatheter arterial chemoembolization with CalliSpheres beads loaded with arsenic trioxide (CBATO-TACE) in the first-line treatment of patients with large (5 cm ≤ maximum diameter＜10 cm) or huge (maximum diameter ≥10 cm) hepatocellular carcinoma (HCC). Methods: Patients were randomly allocated to the CBATO-TACE group and the cTACE group. The primary endpoint was progression-free survival (PFS). The secondary endpoint was overall survival (OS), treatment response, and treatment- related adverse events (TRAEs). The extrahepatic collateral arteries, liver function, and liver fibrosis after the first TACE were also evaluated. Results: From September 2018 to September 2020, a total of 207 patients underwent TACE were consecutively enrolled in this study. The median PFS was 9.5 months (range: 8.0-11.0) in the CBATO group, which was significantly longer than that in the cTACE group (6.0 months, range: 4.0-6.0) ( P< 0.0001). Patients in the CBATO group had a median OS of 22 months (range: 20.0-27.0) compared with 16 months (range:15.0-20.0）in the cTACE group ( P= 0.0084). The most common TRAEs were fever ( P= 0.043), nausea and vomiting ( P= 0.002), which were more observed in the cTACE group. In addition, the progressive disease time, pulmonary metastasis rate ( P= 0.01), the mean number of EHC arteries ( P= 0.01) and average number of TACE sessions ( P= 0.025) were significantly decreased in the CBATO group. Conclusions: CBATO-TACE achieved better therapeutic outcomes and similar safety profile compared to cTACE in large or huge HCC patients. Furthermore, CBATO-TACE was able to reduce extrahepatic collateral arteries production and extrahepatic lung metastasis. Clinical trial information: ChiCTR1800018418 .

Background: This study aimed to compare treatment response, survival and safety profiles between drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres^® microspheres (CSM) and conventional TACE (cTACE) in huge hepatocellular carcinoma (HCC) patients.Methods: 71 patients with huge HCC underwent DEB-TACE or cTACE were consecutively enrolled. Treatment response was assessed at first month (M1), third month (M3) and sixth month (M6) after TACE therapy; progression free survival (PFS) and overall survival (OS) were evaluated; liver function indexes were recorded before TACE operation (M0), at first week (W1), M1 and M6 after TACE therapy; adverse events which occurred after TACE operation were recorded. Results: DEB-TACE presented with higher objective response rate (ORR) and disease control rate (DCR) compared to cTACE. Regarding survival profiles, the short-term mortality rate was lower, and PFS as well as OS were longer in DEB-TACE group compared with cTACE group. Multivariate Cox’s regression further illustrated that DEB-TACE vs cTACE was an independent protective factor for PFS and OS. As for safety profiles, patients’ liver function injury was reduced in DEB-TACE group compared with cTACE group. The incidence of fever was lower and CINV were less severe in DEB-TACE group compared with cTACE group, while no difference in occurrence of liver abscess, increase of ascites or moderate pain between two groups was observed. Conclusion: DEB-TACE with CSM presents with better treatment response, survival profiles as well as safety profiles compared to cTACE in treatment for huge HCC patients.