NCT03876574

Hepatic Artery Infusion Pump for NPC Liver Metastases

Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A retrospective clinical trial to study the safety and effectiveness of hepatic arterial infusion (HAI) in treating patients who have nasopharyngeal carcinoma metastatic to the liver. Hepatic-direction drug administration improves the control power for intra-hapatic lesions.

Detailed description

OBJECTIVES: I. Determine the safety and toxicity of hepatic arterial infusion with gemcitabine, floxuridine and dexamethasone in combination with standard treatment (radiotherapy and systemic chemotherapy) in patients with nasopharyngeal carcinoma metastases to liver. II. Determine the objective response of intrahepatic lesions of patients treated with this regimen. III. Determine the median survival time or overall survival time in patients treated with this regimen. OUTLINE: This is a single-center retrospective study. Patients receive DSA-guided implantation of HAI catheter system. HAI is initiated the next day. Gemcitabine intra-arterially for 30 minutes on day 1,8, floxuridine, dexamethasone intra-arterially continuously on days 1-14. Treatment repeats every 3 weeks in the absence of serious technical catheter-related problems, progression of intrahepatic lesions or unacceptable toxicity. Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) was performed as desired. Patients are followed every 2 HAI cycles or when necessary.

Conditions

• Nasopharyngeal Carcinoma
• Neoplasm Metastasis
• Liver

Interventions

Type	Name	Description
PROCEDURE	DSA-guided implantation of hepatic artery infusion pump	Implant the infusion catheter and injection port (Celsite, B. Braun, Chasseneuil, France) under DSA-guiding. The proximal end of the infusion catheter was connected to the injection port and the device was implanted in a subcutaneous pocket in the right inner thigh; the distal end of the infusion catheter guarantee uni-direction infusion to liver.
DRUG	Gemcitabine	Given intra-arterially for 30 minutes
DRUG	Floxuridine	Given intra-arterially continuously for 14 days
DRUG	dexamethasone	Given intra-arterially continuously with 5-FUDR

Timeline

• Start date: 2011-01-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2019-03-15
• Last updated: 2019-03-15