CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 30 target
Drug / intervention
Fruquintinib,Albumin Paclitaxel,Gemcitabinedrug
Likely dose
Fruquintinib,Albumin Paclitaxel,Gemcitabine 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05168527
NCT05168527Phase 2Unknown

An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer

Fudan University·interventional·Posted Dec 23, 2021·Updated Jan 14, 2022

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
20222023202420252026
First PostedDec 23, 2021
Enrollment StartSep 3, 2021
Primary CompletionMar 2, 2024
Study CompletionMay 31, 2024
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 4.5 years ago

Interventions

Fruquintinib,Albumin Paclitaxel,Gemcitabinedrug

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.