Phase 3 Pancreatic Cancer Trial, Recruiting NCT03257033 Sponsor: RenovoRx Condition: Pancreatic Cancer
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Phase 3 Pancreatic Cancer Trial, Recruiting

NCT03257033
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with pancreatic adenocarcinoma (a specific type of pancreatic cancer), confirmed through a tissue or cell sample, with diagnosis made within 8 weeks of signing consent (or, for those joining at the second treatment cycle, from the start of that cycle)
  • People whose cancer is locally advanced and cannot be surgically removed, as confirmed by a specialist team using a CT or MRI scan taken within 30 days of starting the first treatment cycle
  • People whose general health and ability to carry out daily activities meets a specific medical scoring standard (a score of 0 or 1 on the ECOG scale, meaning fully active or able to carry out light activity) (confirm with trial site)
  • People aged 18 or older
  • People whose blood test results meet specific required levels before starting treatment, including adequate white blood cells, platelets, red blood cells, kidney function, liver enzymes, bilirubin, and blood clotting measures — with some flexibility for people who have recently had a biliary stent placed to help with bile drainage (confirm with trial site for exact values)
  • People expected to live longer than 12 weeks
  • Women who could become pregnant must have a negative pregnancy test within one day before starting chemotherapy, and must agree to use highly effective contraception during treatment and for up to 6 months after treatment ends
  • People who are willing and able to give written informed consent
  • People willing to participate in the study for at least 8 months if assigned to either treatment group

Who may not be able to join:

  • People who have received any prior treatment for pancreatic cancer, or who have already completed more than one cycle of gemcitabine and nab-paclitaxel chemotherapy
  • People who have any signs of cancer that has spread to other parts of the body, or who have had another active cancer in the past year (exceptions include certain limited skin cancers or early-stage cervical or bladder cancers)
  • People who are unable or unwilling to start their assigned treatment within 3 weeks of imaging taken after the initial treatment phase, or within 5 weeks of their last initial treatment dose
  • People who do not have baseline tumour imaging available
  • People whose blood vessel anatomy is not suitable for delivering chemotherapy directly into the artery near the tumour, as assessed and approved by the trial's imaging specialists — this includes blockages or narrowing in the relevant artery, certain vein blockages, or other anatomical factors
  • People for whom a specific type of targeted radiation therapy (SBRT) is not appropriate, including those with cancer involvement of the gut lining seen on internal camera examination, or those who have previously had abdominal radiation that would overlap significantly with the planned new radiation treatment
  • People with a known HIV infection or active hepatitis B or C infection
  • People who have been hospitalised for a serious infection within 4 weeks before starting the study treatment
  • People who have had signs or symptoms of an infection within 2 weeks before starting the study treatment
  • People who have taken antibiotic treatment for an infection within 48 hours before starting the study treatment (people taking preventive antibiotics may still be considered)
  • People with a history of severe allergic reactions to gemcitabine or nab-paclitaxel
  • People who have received any cancer treatment — including chemotherapy, hormone therapy for prostate cancer, or radiation — within 2 weeks before starting study treatment, or herbal anti-cancer therapy within 1 week before starting
  • People with uncontrolled seizures
  • People who have had serious heart problems — such as unstable chest pain, a heart attack, a stroke, dangerous heart rhythm problems, or severe heart failure — within the 3 months before starting the study; or people with a history of certain heart conditions whose heart pumping function is found to be too low (40% or below) on a recent heart scan
  • People with other serious ongoing health conditions that the treating doctor considers would make participation difficult
  • People who have had certain procedures too close to the start of study treatment, including catheterisation, endoscopy, stent or drain placement within 48 hours; minor surgery within 2 weeks; or major surgery within 4 weeks
  • People who are currently breastfeeding
  • People of reproductive potential who do not agree to use highly effective contraception or remain abstinent throughout the study and for 6 months after the last treatment
  • People who have taken part in another clinical trial involving an experimental treatment within 2 weeks before starting this study
  • People with social circumstances or mental health conditions that would make it difficult to follow the study requirements
  • People who are unable or unwilling to undergo a standard catheterisation procedure

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Michael J Pishvaian, Johns Hopkins Kimmel Cancer Center

Phone: 616-516-1162

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
RenovoRx
Registry
ClinicalTrials.gov
Start date
12 March 2018
Est. completion
1 June 2026

Where this trial is recruiting

🇧🇪 Belgium 🇺🇸 United States

Primary endpoints

Overall Survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov