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Cocktail & Poster Display session

32P - Clinical efficacy and safety of an immune checkpoint inhibitor in combination with regorafenib therapy as second-line regimen for patients with unresectable hepatocellular carcinoma


06 Mar 2023


Cocktail & Poster Display session


Jinpeng Li


Annals of Oncology (2023) 8 (1suppl_2): 100903-100903. 10.1016/esmoop/esmoop100903


J. Li, J. Song

Author affiliations

  • Oncology Interventional Therapy Department, Shandong Cancer Hospital and Institute, 250117 - Jinan/CN


This content is available to ESMO members and event participants.

Abstract 32P


This study aimed to evaluate the safety and efficacy of a combination of programmed death-1 (PD-1) inhibitor and regorafenib as second-line treatment for advanced hepatocellular carcinoma (HCC).


We retrospectively analyzed the data of 38 patients with unresectable HCC who were treated with PD-1 inhibitor in combination with regorafenib as a second-line therapy as well as the data of 32 patients treated with regorafenib only therapy as a control. The clinical data including the baseline data from blood routine test, liver function test, renal function test, tumor staging, tumor imaging features, previous treatment strategies, follow-up imaging results, and adverse events during follow-ups were recorded. The mRECIST were used to evaluate the treatment outcome of intrahepatic lesions, and the Kaplan–Meier method was used to evaluate survival time.


Up to the last follow-up, the rego-PD-1 group had higher objective response rate (39.5% vs. 15.6%, P=0.028), longer progression-free survival (median 5.9 vs. 4.6 months; P=0.044), and better overall survival (OS) (median 14.5 vs. 9.5 months; P=0.041) than the regorafenib only group. Among the 38 patients treated with PD-1 inhibitor and regorafenib combination, 1 patient (2.7%) achieved complete response, 14 patients (36.8%) achieved partial response, 14 patients (36.8%) achieved stable disease, and 9 patients (23.7%) achieved progressive disease. Among the 32 patients treated with regorafenib alone, 5 (15.6%) achieved partial response, 12 (37.5%) achieved stable disease, and 15 (46.9%) achieved progressive disease. Regorafenib alone, Child–Pugh B, and presence of more than 3 tumors > 3 were independent prognostic factors for poor OS. The difference in the incidence of grade 3/4 adverse events between the two groups was not statistically significant (36.8% vs. 28.1%; P=0.439). Grade ≥3 treatment-related adverse events (TRAEs) included hypertension and diarrhea.


PD-1 inhibitor combined with regorafenib is a promising regimen in treating patients with unresectable HCC owing to its safety and effectiveness as well as low incidence of serious adverse events with its use.

Clinical trial identification

Editorial acknowledgement


Legal entity responsible for the study

The authors.


Has not received any funding.


All authors have declared no conflicts of interest.

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