Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

Recruiting now · Phase 3

Conditions studied: Locally Advanced Pancreatic Cancer

In brief

The study is a multi-center, open-label, randomized active controlled study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

Key facts

Study ID

NCT03257033

Run by

RenovoRx

People needed

190

Starts

2018-03-12

Expected to finish

2026-09-01

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Age ≥ 18 years
• 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.
• Absolute neutrophil count (ANC) ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine >1.5 mg/dL
• *Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 X the upper normal limit of institution's normal range
• *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)
• 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
• 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
• Life expectancy > 12 weeks
• 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
• Provide written informed consent
• Subjects willing to participate in the study for at least 8 months if randomized to IA gemcitabine OR IV gemcitabine + nab-paclitaxel

You may not qualify if…

• 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
• 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.
• 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
• Subjects without baseline tumor imaging
• 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:
• Stenosis or occlusion in the intended artery for treatment
• Inability to exclude major side branches in the area of the intended RenovoCath® catheter occlusion
• No suitable artery with a diameter greater than 3 mm in proximity of at least one side of the tumor
• 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
• Contraindications for SBRT planning which includes the following:
• Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy
• 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.
• Subjects with known HIV infection or active viral hepatitis
• 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
• Signs or symptoms of infection within 2 weeks prior to the first study treatment, as assessed by the Investigator
• Received antibiotics for treatment of an infection within 48 hours prior to initiation of study treatment. Subjects receiving prophylactic antibiotics are eligible
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
• 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
• Subjects with uncontrolled seizures
• 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
• Other severe concurrent disease or comorbidities which make it difficult to participate in this study, as assessed by Investigator
• Any of the following procedures prior to initiation of study treatment:
• 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)
• Minor surgery requiring light sedation (such as surgical laparoscopy) within 2 weeks

Where it is running

• Oklahoma University - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Iowa Hospitals and Clinics - Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• Prisma Health (formerly Greenville Health System) — Greenville, South Carolina, United States (enrolling)
• Sarasota Memorial Health Care System — Sarasota, Florida, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Sutter Cancer Center Sacramento — Sacramento, California, United States (enrolling)
• West Virginia University Medicine — Morgantown, West Virginia, United States (enrolling)
• Feinstein Institutes for Medical Research - Northwell Health — Manhasset, New York, United States (enrolling)
• Sibley Memorial Hospital - a member of Johns Hopkins medicine — Washington D.C., District of Columbia, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Levine Cancer Institute - Atrium Health — Charlotte, North Carolina, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Miami Cancer Center — Miami, Florida, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States
• Montefiore Hospital — The Bronx, New York, United States
• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Medical University of South Carolina - Hollings Cancer Center — Charleston, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• VA Puget Sound Health Care System — Seattle, Washington, United States
• AZ Sint-Lucas — Bruges, Belgium
• UZ Antwerp — Edegem, Belgium
• AZ Maria Middelares — Ghent, Belgium
• UZ Gent — Ghent, Belgium

Full record on ClinicalTrials.gov

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