978P - Efficacy and safety analysis of transarterial chemoembolization combined donafenib with or without immune checkpoint inhibitors in for unresectable hepatocellular carcinoma (HCC): A prospective, single-arm, single center, phase Ⅱ clinical study

Background

To observe and assess the efficacy and safety of donafenib combined with TACE in the treatment of unresectable hepatocellular carcinoma.

Methods

It was a prospective，single-arm，single center，and phase II clinical study. A total of 36 initial unresectable HCC patients who had not received any systemic treatment were enrolled. The patients received donafenib (100mg po bid)，TACE with or wihout PD-1 inhibitors. The primary endpoint was short-term efficacy based on mRECIST criteria,with secondary endpoints including PFS, TTR, DCR and adverse events (AEs). The diameter of tumor feeding artery was measured.

Results

A total of 36 patients were included in the study, including 26 who received donafenib and TACE and 10 who received donafenib and TACE plus PD-1 inhibitors. A total of 36 subjects were eligible for efficacy evaluation, and among them there were 6 cases of CR, 19 cases of PR, 8 cases of SD and 3 cases of PD; 6 patients (16.7%) successfully underwent conversion therapy and all achieved R0 resection. Two patients achieved a complete pathological response. The ORR was 69.4% and the DCR was 91.7% based on mRECIST criteria. The mPFS was 10.7 months (95%CI: 8.37-NA months), median OS was not reached, median TTR was 1.4 months (95%CI: 0.8-6.9 months). The median survival rates in 6, 12 and 18 months were 85.0%, 77.6% and 71.3%, respectively. The median progression-free survival rates in June, December and 18 months were 65.3%, 45.6% and 34.2%, respectively. Treatment-related adverse events (TRAEs) occurred in all 25 subjects, grade 3 TRAE occurred in 4 subjects (11.3%), and no grade 4 or 5 TRAE occurred. The tumor feeding artery diameter was (4.5±1.4) mm pre-treatment, and reduced to (3.2±1.1) mm post-treatment (P=0.036). The multivariable analysis indicated that the sum of baseline target lesion diameters、best tumor response and combined immunotherapy was an independent predictor for PFS.

Conclusions

TACE combined with donafenib could reduce the tumor feeding artery diameter, which had a good safety profile and a high objective response rate in patients with unresectable HCC.

Clinical trial identification

ChiCTR2100054041.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.