66O - TACE combined with apatinib in patients with intermediate and advanced hepatocellular carcionma: A prospective, multi-center, randomized clinical trial

Background

Transarterial chemoembolization (TACE) is a well-recognized therapy for patients with unresectable hepatocellular carcinoma (HCC). However, the long-term efficacy of TACE remains unsatisfactory. TACE initiates angiogenesis in the residual viable tumor as a result of hypoxia generated by the procedure. Accordingly, the combination of TACE with anti-angiogenic agent might represent an effective strategy to improve outcomes. Apatinib, a highly potent small molecule anti-angiogenic agent, has been proved to improve overall survival (OS) in patients with pretreated advanced HCC. This study aims to evaluate the efficacy and safety of TACE plus apatinib (TACE + Ap) in patients with intermediate and advanced HCC.

Methods

In this prospective, multi-center, randomized clinical trial, patients with intermediate and advanced HCC were randomly assigned into TACE + Ap group or TACE alone group. Patients in the combination group initiated oral apatinib 500 mg once daily, 4 days after TACE treatment. The primary endpoint was progression free survival (PFS). Secondary endpoints included OS, objective response rate (ORR), disease control rate (DCR), and safety.

Results

Between Nov 1, 2018 and May 27, 2022, 196 patients were screened for eligibility, 178 of them were eligible and randomly assigned. Among them, 86 patients received TACE + Ap and 92 received TACE alone. Median PFS was 6.83 months (95% CI, 4.53-10.15) with TACE + Ap and 3.81 months (95% CI, 2.83-4.90) with TACE alone (hazard ratio, 0.53; 95% CI, 0.36-0.80; P = 0.0021). Median OS was not evaluable (95% CI, 13.4-NE) for TACE + Ap and 18.2 months (95%CI, 12.3-NE) for TACE alone. The ORR was 30.23% (95% CI, 20.79-41.08) and 23.91% (95% CI, 15.63-33.94) in the respective groups. The DCR in both groups was 70.93% (95% CI, 60.14-80.22) and 61.96% (95% CI, 51.24-71.88), respectively. Grade ≥ 3 treatment-related adverse events were reported in 14 patients (16.5%) in TACE + Ap group and 8 patients (8.6%) in TACE alone group. No new safety signals were identified.

Conclusions

TACE plus apatinib showed promising efficacy and acceptable safety in patients with intermediate and advanced HCC, and could represent a potential treatment option for these patients.

Clinical trial identification

ChiCTR1800018621.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

This study was supported by the major projects of Chen Xiaoping Science and Technology Development Foundation (CXPJJH11800001-2018102).

Disclosure

All authors have declared no conflicts of interest.