Biliary tract cancer arises from the epithelial cells of the bile ducts. Until nowadays, no standard second-line treatment has been established following recurrence from the first-line treatment. Angiogenesis plays a key role in the carcinogenesis and development of biliary tract adenocarcinoma. Studies have shown that VEGF is expressed in more than 50% of biliary tract adenocarcinoma, and microvessel density is significantly associated with tumor progression, metastasis, and prognosis. Fruquintinib (trade name: Elunate) is a novel small molecule tyrosine kinase inhibitor. It is currently being evaluated in clinical trials for multiple cancers including lung cancer, gastric cancer and colorectal cancer and showed strong anti-tumor activity. The aim of the study is to evaluate the efficacy and safety of fruquintinib for patients with advanced or metastatic biliary tract adenocarcinoma who failed first-line chemotherapy.~The trial is a prospective, multicenter, single-arm design study. Eligible participants with advanced or metastatic biliary tract adenocarcinoma who have failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel. The study will explore the efficacy and safety of second-line treatment with fruquintinib, and quality of life during treatment. Tumor assessment was performed every 8 weeks as defined by RECIST 1.1. Blood samples will be collected at baseline (before treatment) and 2 weeks after treatment, and cfDNA will be collected for gene detection analysis to evaluate the correlation between different gene mutations and their changes and efficacy.
The prospective, multicenter, single-arm design study is to evaluate the efficacy and safety of fruquintinib for patients with advanced or metastatic biliary tract adenocarcinoma who failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel.