A phase II study of bTAE-HAIC combined with lenvatinib and camrelizumab for patients with high tumor burden hepatocellular carcinoma: The TALEM-H trial.

4123 Background: Patients with high tumor burden hepatocellular carcinoma (HCC) face a dismal prognosis. TALEM-H is a single-arm, prospective trial, aiming to evaluate the safety and preliminary effectiveness of transcatheter arterial embolization with blank microspheres (bTAE) plus hepatic artery infusion chemotherapy (HAIC) combined with lenvatinib and camrelizumab as first-line therapy for patients with high tumor burden HCC. Methods: Forty patients with huge HCC (defined as a single tumor >10 cm or multiple tumors >15 cm in diameter) received bTAE and FOLFOX-HAIC (Oxaliplatin 85mg/m2 2h + Calcium Levofolinate 400mg/m2 2h + Fluorouracil 2400mg/m2 46h) and lenvatinib (4-8mg) once daily plus camrelizumab (200mg) Q3W. The primary endpoint was objective response rate (ORR) according to mRECIST criteria. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and treatment-related adverse events (TRAEs). Results: As of January 10, 2026, the median follow-up time was 10.7 months. The median maximum tumor diameter was 124mm (range: 77.5–262 mm) and the median sum of the diameters of the three largest tumors was 182 mm (range: 110–328.5 mm). The intrahepatic ORR was 95%, with 7 cases (17.9%) of intrahepatic complete response (CR) and 30 cases (76.9%) of intrahepatic partial response (PR). The 1-year and 2-year PFS rates were 48.7% and 37.6%, respectively (median PFS: 10.4 months; 95% CI: 8.6–15.1). Median OS has not yet been reached. Further, TRAEs of any grade occurred in 35 patients (87.5%) and no treatment-related deaths occurred. Grade 3 or higher TRAEs occurred in 12.5% of patients, commonly hypoalbuminemia (5%), immune-mediated pneumonitis (2.5%), and anemia (2.5%). Conclusions: bTAE-HAIC combined with lenvatinib plus camrelizumab represents a promising first-line treatment, offering an exceptional ORR and encouraging survival outcomes for HCC patients with a high tumor burden. Clinical trial information: NCT06061276 . Baseline characteristics. Variable All Patients (N = 40) BCLC Stage C 32 (80%) Extrahepatic Metastasis 18 (45%) Tumor Number- Multiple（≥3） 28 (70%) Largest Diameter (cm) >10 cm 35 (87.5%) Sum of the diameters of the three largest tumors >20 cm 14 (35%) Macrovascular Invasion 27 (67.5%)