At a glance
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An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer
In Brief
A Phase 2 clinical trial evaluating Fruquintinib,Albumin Paclitaxel,Gemcitabine for Pancreatic Cancer. Targeting 30 participants across 1 site.
Detailed Summary
The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients.
Study Details
Timeline
Interventions
The study will mainly explore the safety and tolerability of fixed-dose level of Fruquintinib (4 mg, continuous medication for 3 weeks and withdrawal for 1 week) combined with fixed-dose level of albumin paclitaxel and gemcitabine. The fixed dose of Fruquintinib is 4 mg, with a treatment cycle every 28 days. A 28-day observation window was used to explore the side effects of fruquintinib in the combined treatment of pancreatic cancer patients with liver metastases. Evaluable patients will be assessed for DLT within 28 days after the first administration of the study drug. The 24 patients enrolled in the follow-up group will mainly evaluate the initial efficacy of furquintinib combined with albumin paclitaxel and gemcitabine as the first-line standard treatment for patients with metastatic pancreatic cancer.