PD-1 inhibitor combined with lenvatinib for unresectable liver cancer as the conversion therapy: An open-label, non-randomized, phase IV study.

作者：Wenwen Zhang, Shichun Lu, Bingyang Hu, Tao Wan, Hongguang Wang, Jun Han, Ze Zhang, Junning Cao, Xianlei Xin, Yingwei Pan, Minggen Hu, Mingyi Chen, Yongliang Chen, Zhanyu Yang, Shouwang Cai, Wenbin Ji, Chenggang Li, Shuang Tong, Feilong Zhao, Xiaochen Zhao · 发表于：Journal of Clinical Oncology · 年份：2021 · DOI：10.1200/jco.2021.39.15_suppl.e16173 · 被引用次数：12 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers、Ferroptosis and cancer prognosis

e16173 Background: The combination of lenvatinib and PD-1 inhibitor has shown to be a promising regimen for advanced hepatocellular carcinoma (HCC). We aimed to assess the feasibility of conversion therapy by lenvatinib combined with PD-1 inhibitor in unresectable HCC in a non-randomized phase IV study (ChiCTR1900023914). Methods: Eligible patients had histologically or cytologically confirmed unresectable HCC (AASLD); BCLC B or C; an ECOG status of 0 or 1 and Child-Pugh A-B. Patients received lenvatinib (8-12mg, oral QD) and PD-1 inhibitor (IV Q3W) until disease progression, unacceptable toxicity or satisfied for curative surgery. Surgical patients received maintenance therapy based on the pathological evaluation (pCR: PD-1 inhibitor 6-12m, pPR: combination therapy 6-12m, pPD: personalized). The primary endpoint was conversion rate for surgery based on radiological assessment. The secondary endpoints were objective response rate (ORR), disease control rate (DCR), relapse-free survival (RFS) and overall survival (OS) by modified RECIST. Tumor tissue samples were collected at diagnosis and surgery. Immune cell subsets (CD8+ T cell, macrophage, NK cell) in tumor and stromal were measured by multiplex fluorescent immunohistochemistry. Whole exosome sequencing was performed with tumor samples and matched white blood cells. Results: and received the combination therapy. 49 patients were evaluated for the efficacy, 51.0% patients (5 CR, 17 PR and 3 SD) were conversed successfully b...