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Hepatic Artery Infusion Pump for NPC Liver Metastases

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ClinicalTrials.gov Identifier: NCT03876574
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE March 3, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE January 1, 2011
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Disease control rate (DCR) of intrahepatic lesions [ Time Frame: 2 years ]
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Overall survival time [ Time Frame: 7 years ]
    From the date of HAI catheter implantation to the date of death from any cause or to completion of trial, whichever comes first, up to 84 months.
  • Side effects and adverse events [ Time Frame: 2 years ]
    To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hepatic Artery Infusion Pump for NPC Liver Metastases
Official Title  ICMJE Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasopharyngeal Carcinoma
  • Neoplasm Metastasis
  • Liver
Intervention  ICMJE
  • 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
    Other Name: 5-FUDR
  • Drug: dexamethasone
    Given intra-arterially continuously with 5-FUDR
    Other Name: DXM
Study Arms  ICMJE Experimental: Treatment
Patients undergo DSA-guided implantation of hepatic artery infusion pump. All patients receive the intervention "Hepatic artery infusion of gemcitabine and floxuridine" the next day after pump implantation. The HAI therapy is initiated on day 1, 8: Gemcitabine 1g/m2 for 30 minutes, followed by a blended solution which comprised floxuridine (FUDR) at 0.15 mg/kg/day, dexa-methasone (DXM) at 1 mg/m2/day, low molecular heparin 3200U and saline, lasted for 7 days continuously.Standard treatments of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) are performed as desired.
Interventions:
  • Procedure: DSA-guided implantation of hepatic artery infusion pump
  • Drug: Gemcitabine
  • Drug: Floxuridine
  • Drug: dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed nasopharyngeal carcinoma with histologically confirmed or image diagnosed metastatic to the liver
  • Standard treatment of NPC, including radiotherapy and chemotherapy (induction chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) is performed as desired
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)
  • Creatinine no greater than ULN
  • Creatinine clearance greater than 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate oral nutrition (at least 1,500 calories/day)
  • Able to withstand major operative procedure
  • No dehydration
  • No severe anorexia
  • No frequent nausea or vomiting
  • No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
  • No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during the first course of study therapy
  • No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan
  • No prior hepatic artery infusion therapy with 5-FU or floxuridine
  • No prior systemic chemotherapy for metastatic disease
  • No prior or concurrent sorivudine or brivudine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876574
Other Study ID Numbers  ICMJE NPC11330
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xiangya Hospital of Central South University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP