A single-arm, prospective study on the efficacy and safety of TACE-HAIC combined with lenvatinib and tislelizumab in the treatment of unresectable hepatocellular carcinoma.

Abstract

e16143 Background: Hepatocellular carcinoma is one of the common tumors in China. In recent years, innovative drugs such as molecular targeted drugs and immune preparations have begun to be used clinically and have achieved good results. Interventional therapy combined with targeted immunotherapy has become a hot topic in HCC treatment research. However, the matching mode, application timing, efficacy and safety of various combination treatment options are still unclear. Therefore, a study of TACE-HAIC combined with lenvatinib and tislelizumab in the treatment of unresectable hepatocellular carcinoma is conducted to evaluate the efficacy and safety. Methods: According to the inclusion and exclusion criteria, 15 patients with unresectable hepatocellular carcinoma were included, all of whom received TACE-HAIC combined with lenvatinib and tislelizumab. The mRECIST criteria is used to evaluate the objective response rate (ORR) and disease control rate (DCR).The CTCAE version 5.0 is used to grade treatment-related adverse events of TACE-HAIC combined with lenvatinib and tislelizumab. Results: Among the 15 patients included in the study, 14 are male and 1 is female. All patients were treated with TACE-HAIC combined with lenvatinib and tislelizumab as planned, and the treatment was well tolerated. The total number of patients for optimal efficacy evaluation is 15, including 5 patients with CR, 8 patients with PR, and 2 patients with SD. The ORR is 86.7%, and DCR is 100% in best efficacy. In the safety analysis set (n = 15), none TEAEs is ≥ grade 3. In the treatment-related adverse events, abdominal pain(8/15, 53.3%), fever(4/15, 26.7%), vomiting(4/15, 26.7%), weight loss(4/15, 26.7%), nausea(2/15, 13.3%), neutropenia(2/15, 13.3%) and liver function damage(1/15, 6.7%) are all ≤ grade 2. Conclusions: TACE-HAIC combined with lenvatinib and tislelizumab has definite efficacy in the treatment of patients with unresectable hepatocellular carcinoma, with high objective response rate, good treatment tolerance, and controllable treatment-related adverse events. This therapy may be a treatment option for patients with unresectable hepatocellular carcinoma. Clinical trial information: ChiCTR2300067362. [Table: see text]