NCT02635971

Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Detailed description

Primary Outcome Measures: To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy. Secondary Outcome Measures: To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy. Exploratory Outcome Measures: To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Conditions

• Carcinoma, Pancreatic

Interventions

Type	Name	Description
PROCEDURE	Transcatheter arterial infusion
PROCEDURE	Intravenous chemotherapy
DRUG	Gemcitabine
DRUG	Oxaliplatin

Timeline

• Start date: 2015-12-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2015-12-21
• Last updated: 2020-03-05

Locations

1 site across 1 country: China