ALTER-H006: A phase II study of TQB2450 plus anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) with high risk of recurrence after surgical resection.

Authors

null

Xianhai Mao

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

Organizations

Hunan Provincial People's Hospital, Changsha, China; , Hubei Cancer Hospital, Wuhan, China; , Jiangxi Provincial Cancer Hospital, Nanchang, China; , Fujian Provincial Hospital, Fuzhou, China; , Hainan General Hospital, Haikou, China;

Research Funding

Pharmaceutical/Biotech Company
Chia Tai Tianqing Pharmaceutical Group Co., Ltd

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 Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT05111366

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr TPS632)

DOI

10.1200/JCO.2023.41.4_suppl.TPS632

Abstract #

TPS632

Poster Bd #

P1

Abstract Disclosures