1018TiP ALTER-H-004: A phase II study of anlotinib combined with TACE as adjuvant therapy in hepatocellular carcinoma patients at high risk of post-surgery recurrence

Abstract

HCC is one of the most common malignant tumors with high incidence and mortality worldwide. It is acceptable that adjuvant therapy is an efficient treatment for reducing recurrence in patients with hepatectomy, especially in those with high recurrence factors. Regional therapies and tyrosine kinase inhibitors (TKIs), which were recommended as standard treatments for unresectable and advanced HCC pts, had limited and minimal disease free survival as adjuvant therapy, respectively. Anlotinib, a novel multi-target TKI, mainly targeting VEGFR1-3, showed durable anti-tumor activity and manageable toxicity as first or second-line treatment of advanced HCC pts in an open-label phase II trial (NCT02809534). Consistent with these, we conducted a multicenter open label, phase Ⅱ study to evaluate anti-tumor efficacy and safety for anlotinib plus TACE in HCC pts with high recurrence risks after surgery. This was a single arm, multicenter phase II trial. A total number of 48 pts with histologically confirmed HCC would be enrolled. The eligibility criteria included: previously not receive any tumor-related treatment except hepatectomy and met any of the following high recurrence factors: ≥5cm and <10cm of tumor diameter, tumor number ≥3, tumor microvascular invasion grade M1 or M2, portal vein carcinoma thrombus resection (Cheng’s classificationⅠorⅡ); aged 18-75; Child-Pugh Score A5-B7; ECOG 0-1 and HBV-DNA<1000IU/ml for patients with HBV. Treatment regimens were as follows. Pts were received conventional TACE treatment with pirarubicin and lobaplatin within 1-2 months after hepatectomy. On the 4th day after TACE treatment, oral anlotinib (12mg, qd, 2 weeks on 1 week off) was given until disease progression or unacceptable toxicity. Tumor assessment was taken every 3 months according to RECIST v1.1. The primary endpoint was disease free survival (DFS). Secondary endpoints included 1-year DFS rate, time to recurrence and safety. Two patients were enrolled from April 21th, 2020. NCT04213118. The authors.