Hunan Provincial People's Hospital, Changsha, China;
Xianhai Mao , Xiaohui Duan , Dongde Wu , Cuncai Zhou , Yifeng Tian , Jinfang Zheng , Changbo Fu , Guohui Xu , Yannan Bai , Changxiong Wu
Background: Recurrence rate at 5 years for patients with early-stage HCC undergoing resection is between 50% and 70%. The optimal adjuvant treatment strategy for patients with resected HCC has not been proved and there is limited evidence to support a standard regimen for adjuvant treatment. Anlotinib, an oral small molecule antiangiogenic inhibitor, has shown promising anti-tumor activity and manageable toxicity as first or second-line treatment for patients with advanced HCC in an open-label phase II trial (NCT02809534). Anlotinib plus TQB2450, an anti-PD-L1 mAb, has shown anti-tumor activity in some solid tumors, such as biliary tract cancer (NCT03996408) and non-small cell lung cancer (NCT03910127). Here we investigate the efficacy and safety of this regimen as an adjuvant treatment for HCC with a high risk of recurrence after surgical resection. Methods: This is a single-arm, multicenter phase II trial. A total number of 37 patients with histologically or cytologically confirmed HCC will be enrolled. Eligible patients are aged 18-75, ECOG 0-1, Child-Pugh class A, 4~8 weeks after R0 resection with any of the following high-risk factors for recurrence: a) tumor nodules ≥4; b)portal vein tumor thrombus (PVTT): vp1 or vp2; c) hepatic vein tumor thrombus (HVTT): vv1 or vv2. Patients enrolled receive anlotinib (12 mg, p.o., qd, d1-14, q3w) plus TQB2450 (1200 mg, i.v., d1, q3w) until disease recurrence or unacceptable toxicity or up to 18 cycles (~1 year), whichever occurs first. Tumor assessment is performed at the end of the second cycle and every four cycles since that, according to RECIST v1.1. The primary endpoint is 1-year recurrence-free survival (RFS) rate. Secondary endpoints include RFS, 1-year overall survival (OS) rate, and safety. Recruitment for this study began in January 2022. Clinical trial information: NCT05111366.
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Abstract Disclosures
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Xianhai Mao
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First Author: Zheng Wu
2023 ASCO Annual Meeting
First Author: Zheng Wu
2022 ASCO Annual Meeting
First Author: Zheng Wu