Pancreatic CancerNCT02981719
Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
A study testing simultaneous gemcitabine and irreversible electroporation and irreversible electroporation in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- simultaneous gemcitabine and irreversible electroporation and irreversible electroporation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Oct 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
- Screening must be performed no longer than 2 weeks prior to study inclusion
- Maximum tumor diameter ≤ 5 cm
- Histological or cytological confirmation of pancreatic adenocarcinoma;
- Age ≥ 18 years
- PS-classification 0 - 2
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- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
- Hemoglobin level ≥ 115 g/L
- Platelet count ≥ 100*109/l
- Neutrophil count ≥ 2×109/L;
- White blood cell count ≥ 4 ×109/L;
- ALT and AST ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
- Prothrombin time or INR < 1.5 x ULN
- Written informed consent
Who cannot join
- Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
- History of epilepsy
- History of cardiac disease:
- Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
- Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
- Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
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- Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
- Allergy to contrast media
- Any implanted stimulation device
- Any implanted metal stent/device within the area of ablation that cannot be removed
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)
Read the detailed description
in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China] intravenously (over approximately 30 min).
In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE.
The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.
- Conditions
- Pancreatic Cancer
- Being tested
- simultaneous gemcitabine and irreversible electroporation, irreversible electroporation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous gemcitabine and irreversible electroporationProcedure or surgery
gemcitabine intravenous infusion prior to irreversible electroporation treatment
irreversible electroporationProcedure or surgery
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
| Study group | Role | What they receive |
|---|---|---|
| simultaneous gemcitabine and irreversible electroporation | Experimental | gemcitabine intravenous infusion prior to irreversible electroporation treatment. Receives: Procedure: simultaneous gemcitabine and irreversible electroporation |
| IRE group | Other | percutaneous irreversible electroporation for locally advanced pancreatic cancer. Receives: Procedure: irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (number of adverse effects)
Adverse events
Measured: 3 month
Secondary outcomes (4)
Tumor response
Imaging evaluation
Measured: 12 months
Overall survival (OS)
Overall survival (OS) was defined using time of death.
Measured: 36 months
Carbohydrate antigen 19-9 (CA19-9)
carbohydrate antigen 19-9 (CA19-9) levels were measured.
Measured: 1 month
Technical success of ablation
The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PHD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981719
- Sponsor's protocol ID
- Y2016-MS-001
- Status last verified
- Jan 2021
- First submitted
- 31 Oct 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02981719
- Acronym / sponsor ID
- Y2016-MS-001
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)
Detailed description
in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China] intravenously (over approximately 30 min).
In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE.
The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simultaneous gemcitabine and irreversible electroporation | Experimental | Procedure: simultaneous gemcitabine and irreversible electroporationgemcitabine intravenous infusion prior to irreversible electroporation treatment. |
| IRE group | Other | Procedure: irreversible electroporationpercutaneous irreversible electroporation for locally advanced pancreatic cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
- Screening must be performed no longer than 2 weeks prior to study inclusion
- Maximum tumor diameter ≤ 5 cm
- Histological or cytological confirmation of pancreatic adenocarcinoma;
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
- History of epilepsy
- History of cardiac disease:
- Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
- Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
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 |
|---|---|---|
| simultaneous gemcitabine and irreversible electroporationgemcitabine intravenous infusion prior to irreversible electroporation treatment | Procedure or surgery | simultaneous gemcitabine and irreversible electroporation |
| irreversible electroporationpercutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer. | Procedure or surgery | IRE group |
Primary outcome
Safety (number of adverse effects)
Time frame: 3 month
Adverse events
4 secondary outcomes
Tumor response
Time frame: 12 months
Overall survival (OS)
Time frame: 36 months
Carbohydrate antigen 19-9 (CA19-9)
Time frame: 1 month
Technical success of ablation
Time frame: 3 months
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 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Lizhi Niu, PHD study chair
Fuda Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous gemcitabine and irreversible electroporation and irreversible electroporation in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
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 16 inclusion and 10 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Safety (number of adverse effects) (time frame: 3 month). 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 22 Jan 2021.