Pancreatic AdenocarcinomaPhase 1NCT03865563
Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
A Phase 1 study testing Retrograde venous infusion of gemcitabine/lipiodol in people with Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Retrograde venous infusion of gemcitabine/lipiodol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2019to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
- Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
- The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
- Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry
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- Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.1]
- Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)
- The patient is able to give informed consent
- The patient, if a woman of childbearing potential, has a negative pregnancy test
- The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
- Life expectancy of at least 3 months
Who cannot join
- Serum total bilirubin > 3.0 mg/dL
- Creatinine > 2.0 mg/dL
- Platelets < 75,000/μL
- Hgb < 8.0 g/dl
- ANC ≤ 1,000/μL
- INR > 2.0
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- Complete portal vein thrombosis or significant cavernous transformation of the portal vein
- Ascites (trace ascites on imaging is OK)
- The patient is pregnant or breast-feeding
- The patient is allergic to contrast media that cannot be readily managed or prevented with premedication
- Patients with peripheral neuropathy [> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)]
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
Read the detailed description
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.
Complete enrollment in 12 months from date of enrollment of first study subject.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Retrograde venous infusion of gemcitabine/lipiodol
- Keywords
- retrograde venous infusion, chemotherapy, gemcitabine, lipiodol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde venous infusion of gemcitabine/lipiodolDrug
Also called Pancreatic retrograde venous infusion (PRVI)
Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic adenocarcinoma | Experimental | Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol Receives: Drug: Retrograde venous infusion of gemcitabine/lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor.
Measured: 30 days
Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI
Measured: 30 days
Secondary outcomes (3)
Efficacy as assessed by Objective tumor response
Objective tumor response is measured as number of participants with response as determined by RECIST 1.1 criteria to assess change in tumor size and percent tumor enhancement as visualized on pancreatic protocol CT scans.
Measured: 30 days
Efficacy as assessed by change in serum CA19-9
Change in serum CA19-9 measurements pre- and post-PRVI.
Measured: Change from baseline to 30 days
Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples
Change in levels of gemcitabine and its inactive metabolite 2',2'-Difluorodeoxyuridine (dFdU) found in peripheral blood samples pre-and post-PRVI.
Measured: Change from baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study startJul 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: We need to make significant adjustments to proposed drug and its delivery method
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Model description
- This is an open-label, single institution, single-arm pilot study, designed to assess the feasibility, safety and efficacy of retrograde venous infusion of gemcitabine/Lipiodol® administered in a neoadjuvant setting for the treatment of patients with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert P Liddell, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865563
- Sponsor's protocol ID
- J1936
- Other IDs
- IRB00164996
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT03865563
- Acronym / sponsor ID
- J1936
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- retrograde venous infusion, chemotherapy, gemcitabine, lipiodol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We need to make significant adjustments to proposed drug and its delivery method
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 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.
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
Detailed description
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.
Complete enrollment in 12 months from date of enrollment of first study subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single institution, single-arm pilot study, designed to assess the feasibility, safety and efficacy of retrograde venous infusion of gemcitabine/Lipiodol® administered in a neoadjuvant setting for the treatment of patients with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma.
| Arm | Type | Receives |
|---|---|---|
| Pancreatic adenocarcinoma | Experimental | Drug: Retrograde venous infusion of gemcitabine/lipiodolParticipants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
- Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
- The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
- Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
Key exclusion criteria (11 listed)
- Serum total bilirubin > 3.0 mg/dL
- Creatinine > 2.0 mg/dL
- Platelets < 75,000/μL
- Hgb < 8.0 g/dl
- ANC ≤ 1,000/μL
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 |
|---|---|---|
| Retrograde venous infusion of gemcitabine/lipiodolAlso: Pancreatic retrograde venous infusion (PRVI)Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered. | Drug | Pancreatic adenocarcinoma |
Primary outcome
Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
Time frame: 30 days
Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor.
Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
Time frame: 30 days
Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI
3 secondary outcomes
Efficacy as assessed by Objective tumor response
Time frame: 30 days
Efficacy as assessed by change in serum CA19-9
Time frame: Change from baseline to 30 days
Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples
Time frame: Change from baseline to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Robert P Liddell, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retrograde venous infusion of gemcitabine/lipiodol in people with Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 12 inclusion and 11 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: withdrawn, as of the sponsor's last update on 27 Jan 2020. 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 United States. 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol® (time frame: 30 days). The study lists 2 primary outcomes in all. 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 27 Jan 2020.