Nasopharyngeal CarcinomaPhase 1NCT03876574
Hepatic Artery Infusion Pump for NPC Liver Metastases
A Phase 1 study testing DSA-guided implantation of hepatic artery infusion pump, Gemcitabine and Floxuridine in people with Nasopharyngeal Carcinoma and Neoplasm Metastasis, run by Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma, Neoplasm Metastasis, Liver
- What is being tested?
- DSA-guided implantation of hepatic artery infusion pump, Gemcitabine and Floxuridine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 27Show fewer
- 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
Who cannot join
None listed.
About this study
Official title: Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases
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.
Read the detailed description
OBJECTIVES:
- 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
- Being tested
- DSA-guided implantation of hepatic artery infusion pump, Gemcitabine, Floxuridine, dexamethasone
- Keywords
- Hepatic artery infusion pump, Gemcitabine, Floxuridine
- Medical subject headings
- Nasopharyngeal Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA-guided implantation of hepatic artery infusion pumpProcedure or surgery
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.
GemcitabineDrug
Given intra-arterially for 30 minutes
FloxuridineDrug
Also called 5-FUDR
Given intra-arterially continuously for 14 days
dexamethasoneDrug
Also called DXM
Given intra-arterially continuously with 5-FUDR
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Procedure: DSA-guided implantation of hepatic artery infusion pump; Drug: Gemcitabine; Drug: Floxuridine; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR) of intrahepatic lesions
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria.
Measured: 2 years
Secondary outcomes (2)
Overall survival time
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.
Measured: 7 years
Side effects and adverse events
To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876574
- Sponsor's protocol ID
- NPC11330
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases
- ClinicalTrials.gov ID
- NCT03876574
- Acronym / sponsor ID
- NPC11330
- Conditions
- Nasopharyngeal Carcinoma, Neoplasm Metastasis, Liver
- Keywords
- Hepatic artery infusion pump, Gemcitabine, Floxuridine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: DSA-guided implantation of hepatic artery infusion pump, Drug: Gemcitabine, Drug: Floxuridine, Drug: dexamethasonePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSA-guided implantation of hepatic artery infusion pumpImplant 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. | Procedure or surgery | Treatment |
| GemcitabineGiven intra-arterially for 30 minutes | Drug | Treatment |
| FloxuridineAlso: 5-FUDRGiven intra-arterially continuously for 14 days | Drug | Treatment |
| dexamethasoneAlso: DXMGiven intra-arterially continuously with 5-FUDR | Drug | Treatment |
Primary outcome
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.
2 secondary outcomes
Overall survival time
Time frame: 7 years
Side effects and adverse events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DSA-guided implantation of hepatic artery infusion pump, Gemcitabine and Floxuridine in people with Nasopharyngeal Carcinoma and Neoplasm Metastasis, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) of intrahepatic lesions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.