Sintilimab Combined with Lenvatinib for Advanced Intrahepatic Cholangiocarcinoma in Second-Line Setting—A Multi-Center Observational Study

• DOI: 10.3389/fonc.2022.907055
• Publication Date: 2022-07-14T04:31:22Z
• Authors: Xiaoyan Ding; Guangxin Li; Wei Sun; Yanjun Shen; Ying Teng; Yawen Xu; Wendong Li; Mei Liu; Jinglong Chen
• Keywords: Clinical endpoint; Intrahepatic Cholangiocarcinoma; Lenvatinib; Single Center

Patients with advanced intrahepatic cholangiocarcinoma (iCCA) have a poor prognosis and substantial unmet clinical need. The study was aimed to investigate the efficacy safety of sintilimab combined lenvatinib for iCCA in second-line setting.The patients at multiple centers, who progressed after first-line chemotherapy or could not tolerate chemotherapy, were treated combination plus lenvatinib. primary endpoint time progression (TTP), secondary endpoints included tumor objective response rate (ORR), disease control (DCR), overall survival (OS), toxicity. Prognostic factors analyzed using Cox regression analysis.A total 41 enrolled this multi-center observational study. Under median follow-up 12.1 months, age 59 years (range, 33-75 years). Sixteen died progression, TTP 6.6 months (95% CI, 4.9-8.3). ORR DCR 46.3% 70.3%, respectively. PD-L1 TPS ≥10% reported significantly higher compared those <10%, 93.8% (15/16) vs. 16.0% (4/25), p<0.001. improved ≥10%, 16.9 7.5-26.3) 4.1 1.8-6.4), p=0.001. Attaining treatment predicts favorable multivariate model. Treatment-emergent adverse events occurred 70.3% probability, no treatment-related death had been reported.The is effective well tolerated setting. expression may predict therapy. Further investigation warranted regimen iCCA.