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Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma

2019-11-13 17:56:45 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Biliary Tract Adenocarcinoma

Intervention

Fruquintinib

Location

Chinese PLA General Hospital 5th Medical Center
Beijing
Beijing
China
610041

Status

Not yet recruiting

Source

Sichuan University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-13T17:56:45-0500

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Medical and Biotech [MESH] Definitions

Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.

Diseases in any part of the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.

Any surgical procedure performed on the biliary tract.

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