Safety and efficacy of transcatheter chemoembolization combined with hepatic arterial infusion chemotherapy for unresectable primary liver cancer: a single-center prospective study.

Background: Primary liver cancer (PLC) is a leading cause of cancer-related mortality, with many patients ineligible for curative resection. Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are two key interventional therapies recommended for unresectable cases. Recent studies suggest that combining them may enhance treatment efficacy compared to either approach alone. This prospective study aims to evaluate the safety and efficacy of TACE combined with HAIC in patients with unresectable PLC. Methods: Patients with unresectable primary hepatocellular carcinoma (China Liver Cancer stage IIa-III, without distant metastasis) who received TACE combined with HAIC from February 2023 to September 2024, at the Department of Interventional Treatment, Beijing No. 6 Hospital, were included. The primary endpoint was overall survival (OS) and progression-free survival (PFS). Safety was evaluated in all patients who received at least one treatment cycle. Tumor response was assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results: Among the 29 eligible patients, the median follow-up month was 16 months. The mRECIST assessments were available for 22 patients. Among them, six (27.3%) achieved complete response, 11 (50.0%) showed partial response, two (9.1%) showed progressive disease, and three (13.64%) showed stable disease. The objective response rate was 77.3%, and the disease control rate was 90.9%. Three patients (10.3%) underwent successful surgical resection following treatment. Median OS and PFS were not reached. The estimated 6-, 12-, and 18-month OS rates were 90%, 85% and 85%, respectively. No grade 3-5 treatment-related adverse events were observed. Conclusions: In patients with China Liver Cancer stage IIa-III, the combined treatment demonstrated a favorable safety profile and preliminary efficacy, also enabling transformative resection in some patients.