A phase II trial of hyperthermic intraperitoneal chemotherapy combined with tislelizumab and targeted therapy in high-risk hepatocellular carcinoma after R0 resection.

Abstract

TPS635 Background: Hepatocellular carcinoma (HCC) is the predominant form of liver cancer, accounting for 75%–85% of cases, for which surgical resection represents the most effective treatment, with curative potential. However, the high incidence of tumor relapse (50%–70% 5 years after surgery) has hindered improved survival. Furthermore, early recurrence within 2 years after surgery accounts for 70% of relapsed HCC cases, is rarely treatable, and has been associated with poor survival. With the development of novel tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors for advanced HCC, the management of patients has been greatly improved. However, no guidelines for novel systematic therapy to treat high risk of relapse HCC have been established. Targeted therapy combined with immunotherapy as systemic treatment has become a new approach in high risk of relapse HCC. Hyperthermic intraperitoneal chemotherapy (HIPEC), as an adjuvant treatment of abdominal malignant tumors, has achieved unique effects in the treatment of many cancers. The aim of this study was to assess the activity and feasibility of a combination of HIPEC with Tislelizumab and TKIs for the treatment of high risk of relapse HCC. Methods: The single-center, open-label, one-armed, Phase 2 study (NCT05546619) will enroll ~30 adults who meet the diagnostic criteria of high risk of relapse HCC (multiple tumors or satellite lesions; tumor diameter > 5cm; HCC rupture and bleeding; combined with vascular invasion; AFP > 32ng/ml). Patients will receive the following treatments as noted in the table. The primary and secondary endpoints are listed in the table. Tumor response will be evaluated once every 6 weeks for the first 48 weeks of treatment, and once every 12 weeks thereafter according to RECIST v1.1; safety will be assessed through monitoring the incidence and severity of adverse events graded according to CTCAE 5.0, vital signs and clinical laboratory results. Clinical trial information: NCT05546619 . [Table: see text]