New catheter method aims chemo directly at pancreatic tumors

NCT ID NCT03257033

Disease control Sponsor: RenovoRx Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether delivering chemotherapy directly into the artery feeding the tumor can help people with locally advanced pancreatic cancer live longer. Participants first get standard chemo and radiation, then are randomly assigned to either continue standard IV chemo or receive gemcitabine through a special catheter. The study aims to enroll 190 people and is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Gemcitabine (chemotherapy) and nab-paclitaxel (chemotherapy), delivered via a catheter into the artery
What this could lead to: If it works, this could offer a more effective way to deliver chemotherapy directly to the tumor, potentially improving survival for people with advanced pancreatic cancer.
What could go wrong: This is a Phase 3 trial, but the approach is still experimental. It may not improve survival compared to standard treatment, and there are risks from the catheter procedure and chemotherapy side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 8 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2 2. Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the start of cycle 1) 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 4. Age ≥ 18 years 5. Adequate laboratory values prior to receiving the first dose of nab-paclitaxel and gemcitabine: (criterion must be met prior to cycle 2.) For a subject with elevated bilirubin, AST or ALT, who has had a biliary stent placed, if the subject's lab values have returned to within the required range for eligibility noted below in sub-criteria e and f \[(AST) ALT ≤ 3.0 X the upper normal limit, and total bilirubin ≤ 1.5 X the upper normal limit\] after placement of stent and prior to cycle 2, he/she is eligible for the study. Additional details regarding eligibility for subjects who have had biliary stents recently placed are outlined in sub-criteria f and h below. 1. Absolute neutrophil count (ANC) ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Hemoglobin ≥ 9.0 g/dL 4. Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine \>1.5 mg/dL 5. \*Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 X the upper normal limit of institution's normal range 6. \*Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range -OR- If biliary stent is placed or planned to be placed within 6 weeks of Cycle 1 Day 1 (C1D1), total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range (see section 9.1.4 for dose modification due to elevated bilirubin) 7. Prothrombin time (PT) and partial thromboplastin time (PTT) must be ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion 8. International normalized ration (INR) ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion \*For elevated AST, ALT, and total bilirubin at screening, subject must have a normalized result prior to initiation of Cycle 2 if abnormal labs are considered related to bile duct obstruction and a biliary stent has been placed 6. Life expectancy \> 12 weeks 7. Negative pregnancy test for women of childbearing potential (either serum or urine) within one day prior to administration of the first dose of chemotherapy. Women of childbearing potential should use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation 8. Provide written informed consent 9. Subjects willing to participate in the study for at least 8 months if randomized to IA gemcitabine OR IV gemcitabine + nab-paclitaxel Exclusion Criteria: 1. Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on their first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies to the first gemcitabine and nab-paclitaxel dose and must be within 6 weeks of confirmed diagnosis 2. Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. 3. Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment 4. Subjects without baseline tumor imaging 5. As determined by the Sponsor: Arterial anatomy unsuitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined and approved by the Sponsor Imaging Advisor, which includes the following: 1. Stenosis or occlusion in the intended artery for treatment 2. Inability to exclude major side branches in the area of the intended RenovoCath® catheter occlusion 3. No suitable artery with a diameter greater than 3 mm in proximity of at least one side of the tumor 4. Superior mesenteric vein (SMV) occlusion or stenosis that cannot be resolved with medication or intervention prior to randomization, if the superior mesenteric artery (SMA) is the only viable treatment artery Note: Arterial Anatomy will be reviewed by the Sponsor, RenovoRx Imaging Advisor, and RenovoRx Medical Monitor for approval 6. Contraindications for SBRT planning which includes the following: 1. Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy 2. Prior abdominal radiotherapy judged to have clinically significant degree of overlap with planned SBRT dose distribution Note: Primary tumors with a diameter greater than 7 cm must be assessed on a case-by-case basis with the RenovoRx Imaging Advisor prior to excluding the subject from the trial. 7. Subjects with known HIV infection or active viral hepatitis 8. Severe infections requiring hospitalization within 4 weeks prior to the first study treatment, including but not limited to complications of infection, bacteremia or severe pneumonia 9. Signs or symptoms of infection within 2 weeks prior to the first study treatment, as assessed by the Investigator 10. Received antibiotics for treatment of an infection within 48 hours prior to initiation of study treatment. Subjects receiving prophylactic antibiotics are eligible 11. History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel 12. Any anti-cancer therapy including chemotherapy, hormonal therapy for prostate cancer, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment 13. Subjects with uncontrolled seizures 14. Cardiovascular disease including unstable angina or life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction (MI), congestive heart failure (CHF), coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction (EF) to ensure EF is not ≤ 40% (as determined by MRI, ECHO, or Nuclear Scan), within the last 3 months prior to the initiation of study treatment 15. Other severe concurrent disease or comorbidities which make it difficult to participate in this study, as assessed by Investigator 16. Any of the following procedures prior to initiation of study treatment: 1. Catheterization, endoscopy, stent or drain placement within 48 hours. (Diagnostic laparoscopy without surgical intervention and/or port placement do not require any wait time prior to study treatment) 2. Minor surgery requiring light sedation (such as surgical laparoscopy) within 2 weeks 3. Major surgery within 4 weeks 17. Women who are breastfeeding 18. Male or female subjects of reproductive potential who do not agree to either remain abstinent or employ highly effective and acceptable forms of contraception throughout their participation in the study and for 6 months after the last study treatment 19. Subjects receiving any other investigational agents within 2 weeks prior to the initiation of treatment 20. Any social situations or psychiatric illness that would limit compliance with study requirements 21. Subjects unable or unwilling to have standard catheterization procedure

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced pancreatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

15 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

21st Century Oncology
TERMINATED

Fort Myers, Florida, 33907, United States
ASCLEPES Research Centers
TERMINATED

Weeki Wachee, Florida, 34607, United States
AZ Delta
TERMINATED

Roeselare, 8800, Belgium
AZ Maria Middelares
TERMINATED

Ghent, 9000, Belgium
AZ Sint-Lucas
TERMINATED

Bruges, 8310, Belgium
Albany Stratton VA Medical Center
WITHDRAWN

Albany, New York, 12208, United States
Atlantic Health System - Morristown Medical Center
WITHDRAWN

Morristown, New Jersey, 07960, United States
Columbia University Medical Center
TERMINATED

New York, New York, 10032, United States
Comprehensive Cancer Care and Research Institute of Colorado, CCCRIC
WITHDRAWN

Englewood, Colorado, 80113, United States
Dartmouth-Hitchcock Medical Center
TERMINATED

Lebanon, New Hampshire, 03766, United States
East Carolina University
RECRUITING

Greenville, North Carolina, 27834, United States
Feinstein Institutes for Medical Research - Northwell Health
RECRUITING

Manhasset, New York, 11030, United States
Georgetown University
WITHDRAWN

Washington D.C., District of Columbia, 20057, United States
Jolimont Hospital
TERMINATED

La Louvière, 7100, Belgium
LSU Health Shreveport
WITHDRAWN

Shreveport, Louisiana, 71103, United States
Levine Cancer Institute - Atrium Health
RECRUITING

Charlotte, North Carolina, 28204, United States
MD Anderson Cancer Center at Cooper Hospital
TERMINATED

Camden, New Jersey, 08103, United States
Medical University of South Carolina - Hollings Cancer Center
ACTIVE_NOT_RECRUITING

Charleston, South Carolina, 29425, United States
Medstar Franklin Square
TERMINATED

Baltimore, Maryland, 21237, United States
Miami Cancer Center
RECRUITING

Miami, Florida, 33167, United States
Moffitt Cancer Center
TERMINATED

Tampa, Florida, 33612, United States
Montefiore Hospital
TERMINATED

The Bronx, New York, 10461, United States
Ochsner Clinic Foundation
WITHDRAWN

New Orleans, Louisiana, 70121, United States
Oklahoma University - Stephenson Cancer Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Piedmont-Columbus Regional - John B. Amos Cancer Center
WITHDRAWN

Columbus, Georgia, 31904, United States
Prisma Health (formerly Greenville Health System)
RECRUITING

Greenville, South Carolina, 29605, United States
Rocky Mountain Cancer Centers
WITHDRAWN

Denver, Colorado, 80218, United States
Sarah Cannon Research Institute
WITHDRAWN

Nashville, Tennessee, 37203, United States
Sarasota Memorial Health Care System
RECRUITING

Sarasota, Florida, 34329, United States
Sibley Memorial Hospital - a member of Johns Hopkins medicine
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Sutter Cancer Center Sacramento
RECRUITING

Sacramento, California, 95816, United States
UZ Antwerp
TERMINATED

Edegem, 2650, Belgium
UZ Gent
WITHDRAWN

Ghent, 9000, Belgium
University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center
RECRUITING

Iowa City, Iowa, 52242, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68198, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
VA Loma Linda Healthcare System
TERMINATED

Loma Linda, California, 92357, United States
VA Puget Sound Health Care System
WITHDRAWN

Seattle, Washington, 98108, United States
Wake Forest Baptist Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING

Winston-Salem, North Carolina, 27157, United States
West Virginia University Medicine
RECRUITING

Morgantown, West Virginia, 26506, United States

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