Biliary Tract Adenocarcinoma Clinical Trial
Official title:
An Exploratory Study to Evaluate Efficacy and Safety of Fruquintinib as Second-line Treatment for Patients With Advanced or Metastatic Biliary Tract Cancer
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05350943 -
HAIC Combined With Toripalimab and Donafenib for Advanced BTC
|
Phase 2 | |
| Active, not recruiting |
NCT01588860 -
Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma
|
N/A |