137P - Hepatic arterial infusion chemotherapy combined with lenvatinib and tislelizumab for unresectable hepatocellular carcinoma: A single-arm, phase II study

Background

Patients (Pts) with unresectable hepatocellular carcinoma (uHCC) have few treatment choices due to the inadequacy of standard treatments. Retrospective studies show promise for improved survival in uHCC by combining HAIC, PD-1 inhibitors, and lenvatinib. This phase II study evaluates the efficacy and safety of HAIC combined with lenvatinib and tislelizumab in uHCC, seeking to enhance treatment strategies for this pts group.

Methods

Eligible pts were aged ≥18 years with histologically confirmed uHCC, an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1, Child-Pugh (C-P) class A/B. Patients received HAIC with modified FOLFOX (oxaliplatin 85 mg/m²; leucovorin 400 mg/m²; 5-fluorouracil bolus 400 mg/m² on day 1; 5-fluorouracil infusion 2400 mg/m² over 46 hours), lenvatinib, and tislelizumab (200 mg every 3 weeks). HAIC could be repeated as needed. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), ORR per mRECIST, disease control rate (DCR), surgical conversion rate, and safety.

Results

Among the 50 pts, 66.0% had tumors with a diameter ≥10 cm, 86.0% had macrovascular invasion, and 22.0% had extrahepatic metastasis. The median follow-up time was 23.7 months (95% CI: 16.2 – 31.1 months). The ORR was 52.0% per RECIST 1.1 and 80% per mRECIST. The DCR was 96.0% based on both RECIST 1.1 and mRECIST. The median PFS was 11.2 months (95% CI: 5.2 − 17.2 months), the median OS was 16.1 months (95% CI: 12.2 − 20.0 months), and the median duration of response (DOR) was 11.7 months (95% CI: 8.1 − 15.3 months). Thirteen pts underwent surgery, achieving a 100% R0 resection rate, a pathological complete response rate of 30.8%, and a 12-month recurrence-free survival rate of 61.5%. Most adverse events (AEs) were grade 1 or 2. Grade 3 - 4 AEs occurring in 30.0% of pts, most common being increased ALT (8.0%), Hyperbilirubinemia (6.0%) and hypertension (4.0%).

Conclusions

HAIC combined with lenvatinib and tislelizumab showed meaningful clinical benefits and acceptable safety in uHCC pts.

Clinical trial identification

ChiCTR2200064384.

Legal entity responsible for the study

The authors.

Funding

The Clinical Research Project of the Second Affiliated Hospital of Nanchang University.

Disclosure

All authors have declared no conflicts of interest.