Transarterial infusion chemotherapy (TAI) combined with Sintilimab in locally advanced, potentially resectable hepatocellular carcinoma (HCC).

e16593 Background: Our previous studies showed that TAI with modified FOLFOX increased tumor response and resection rate compared with conventional TACE in advanced HCC. PD-1/PD-L1 inhibitors have been demonstrated promising value in HCC. This study aims to evaluate the efficacy and safety of FOLFOX-TAI combined with Sintilimab (a PD-1 inhibitor) in locally advanced, potentially resectable HCC. Methods: This prospective, nonrandomized controlled phase II study is recruiting 40 pts with locally advanced, potentially resectable HCC (localized to semi-liver with invasion to branch of the portal vein). Pts in the combined group receive repeated 3-week cycles of Sintilimab 200mg IV Day1 and TAI with FOLFOX Day2 (Oxaliplatin 130 mg/m 2 , Leucovorin 400 mg/m 2 , 5-FU 400 mg/m 2 and 5-FU 2400 mg/m 2 , next 46 hours). Pts in the control group only received TAI. Tumor assessment with RECIST 1.1 was performed every 2 cycles. The pts gained visible tumor shrinkage and opportunity for resection received surgical hepatectomy. Pts with stable disease (SD) or unconfirmed progression disease (PD) will receive repeated cycles until confirmed PD or intolerable toxicity, with max cycles of 8 for TAI and 16 for Sintilimab. The primary endpoint is progression or postoperative relapse free survival (PFS). Secondary endpoints include ORR, DCR, resection rate, OS, and safety. Results: As of Jan 10, 2020, 33 eligible pts were enrolled. All treatment related AEs were grade 1 or 2, including transaminase and bilirubin increase, nausea, hypoalbuminemia, rash, leucopenia, thrombopenia, and weight loss. No irAE and treatment related SAE was observed. Conclusions: TAI combined with Sintilimab attributed to high surgical conversion rate and good safety profile for locally advanced, potentially resectable HCC. Clinical trial information: NCT03869034 .