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The combination of hepatic arterial infusion chemotherapy (HAIC) and an investigational PD-1 checkpoint inhibitor offered good outcomes in advanced hepatocellular carcinoma (HCC), a researcher reported.

In the trial testing -HAIC plus sintilimab in 29 patients with potentially resectable HCC, progression-free survival (PFS) and overall survival (OS) rates at 1 year were 57.6% and 82.3%, respectively, reported Li Xu, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China.

With 17.1 months of follow-up, median PFS and OS were not reached, Xu said at a press conference during the European Association for the Study of the Liver (EASL) virtual meeting.

Xu reported that the objective response rate was 44.8% and the disease control rate was 75.9%. Of the 29 patients, 19 (65.5%) underwent hepatectomy -- most after two sessions of the combo treatment -- and three achieved a pathologic complete response (pCR). Two other patients with a strong response to therapy underwent radical ablation, and one of those individuals also achieved a pCR that was confirmed with needle biopsy. Xu said 14 of the patients remain tumor free.

As for adverse events (AEs), most treatment-related AEs were grades 1 and 2, with the most common being pyrexia, rash, and pruritus, each in 10% of patients. One patient experienced a serious treatment-related AE -- a grade 4 postoperative liver dysfunction -- and permanently discontinued the study drug but remains tumor free, Xu reported.

"FOLFOX-HAIC in combination with sintilimab is a safe and successful conversion therapy providing outstanding PFS to advanced HCC," Xu stated, noting that "our results are almost all in [hepatitis B virus-related] HCC."

Xu recommend that investigators in other countries test this new strategy. "Maybe more and more patients with advanced HCC could be cured," said Xu, who acknowledged that HCC treatment in China might be considered more aggressive than in Western countries.

EASL press conference moderator Tobias Böttler, MD, of the Universitätsklinikum Freiburg in Germany, noted that "General use of this therapy will depend on its approval in different countries, but checkpoint therapy should be first-line treatment in systemic therapy. I'm very hopeful that we'll be able to combine several of these treatments in the future."

Sintilimab is a PD-1 inhibitor approved for use in China, and showed its efficacy in HCC in the phase III . In May 2021, developer Innovent Biologics announced that the FDA had accepted its biologics license application for the agent as first-line treatment in non-small cell lung cancer.

For the current study, Xu and colleagues enrolled 30 people (median age 50.5; 93.3% men), of whom 96.7% had hepatitis B. The median tumor size was 9.7 cm, and about half of the patients had multiple tumors. All patients presented with vascular invasion (n=26 portal vein; n=15 hepatic vein), although all were believed to be free of metastases, according to Xu.

The median treatment cycle was 2 years. Patients received IV sintilimab at a dose of 200 mg on day 1, and then started a 46-hour infusion of chemotherapy the next day. The cycle was repeated every 3 weeks. The researchers evaluated the tumors every 6-8 weeks. Patients who achieved tumor reduction and became eligible for R0 resection were referred for hepatectomy, then continued with sintilimab monotherapy for a maximum of 16 courses.

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