977P - Hepatic arterial infusion chemotherapy (HAIC) combined with Regorafenib and PD-1 inhibitors versus Regorafenib combined with PD-1 inhibitors for second-line treatment Hepatocellular carcinoma (HCC)

Background

Hepatocellular carcinoma (HCC) is a prevalent malignant tumor globally, Hence, there is an urgent need for safer and more effective options to improve the survival rates of HCC patients. This study aims to evaluate the viability, efficacy, and safety of HAIC and Regorafenib combined with PD-1 inhibitors for treating advanced HCC patients.

Methods

This is a multicenter, randomized controlled clinical study of hepatocellular carcinoma. Eligible individuals with unresectable HCC were randomized into either the HAIC combined with regorafenib and PD-1 inhibitors group (HAIC+REG+ICIs group) or the regorafenib combined with PD-1 inhibitors group (REG+ICIs group). The primary endpoint is the objective response rate (ORR). Secondary endpoints include PFS, OS, DCR (all assessed by BICR per RECIST v1.1), and safety.

Results

Up to April 24, 2023, a total of 45 patients were enrolled and all patients are available for analysis. The HAIC+REG+ICIs group and the REG+ICIs group included 28 and 17 patients, respectively.The median age were 52.5 years (range, 32-68) and 47.0 years (range, 24-79), 92.9% and 94.1% were male for each group, the proportions of child-pugh A/B were 64.3%/35.7% vs. 88.2%/11.8%; and the patients with China Liver Cancer Staging (CNLC) Ib/IIa/IIb/IIIa/IIIb/IV stage were 0.0%/3.6%/35.7%/21.4%/32.1%/7.1% vs. 5.9%/11.8%/47.1%/11.8%/17.6%/5.9%, respectively. All patients were infected with HBV. The median follow-up time was 16.6 months (1-21.2). The ORR was 39.3% (11/28) and 29.4%(5/17) for HAIC+REG+ICIs group and the REG+ICIs group, P=0.502. DCR was 82.1%(23/28) and 52.9%(9/17) respectively, P=0.036. The median OS of HAIC+REG+ICIs group was significant longer than REG+ICIs group (19.1 vs. NA months, P=0.03; HR=0.039 95% CI: 0.101-0.941). This study is currently ongoing.

Conclusions

HAIC combined with Regorafenib and PD-1 inhibitors compared with Regorafenib and PD-1 inhibitors showed a better tumor response rate, but there was no significant difference. However HAIC combined with regorafenib and PD-1 inhibitors can significantly prolong the overall survival of second-line HCC patients.

Clinical trial identification

ChiCTR2100046555.

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.