Phase 2 Pancreatic Cancer Trial, Recruiting NCT03977233 Sponsor: UNC Lineberger Comprehensive Cancer Center Condition: Pancreatic Cancer
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Phase 2 Pancreatic Cancer Trial, Recruiting

NCT03977233
Recruiting Phase 2

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 signed a written consent form agreeing to take part in the study and allowing their personal health information to be shared.
  • People who have been confirmed through a tissue or cell sample test to have adenocarcinoma of the pancreas (a specific type of pancreatic cancer) with no sign that the cancer has spread to distant parts of the body.
  • People whose overall health means surgery to remove the pancreatic cancer has not been ruled out, as assessed by the surgical team involved in the trial.
  • People who are willing to have a biopsy (a small tissue sample taken using a special imaging-guided procedure) of the pancreatic mass before and after treatment.
  • People whose cancer is measurable or can otherwise be assessed using standard imaging criteria, and whose cancer is classified as resectable (able to be surgically removed), borderline resectable, or locally advanced but not yet spread further.
  • People who are generally well enough to carry out daily activities with no restriction or only mild limitations (confirmed using a standard medical scoring system called ECOG 0 or 1).
  • People who have not previously received chemotherapy, radiation therapy, or surgery for their pancreatic cancer.
  • People who are 18 years of age or older.
  • People whose liver, kidneys, and other organs are functioning adequately at the time of joining the study.
  • People who have a life expectancy of at least 6 months.

Who may not be able to join:

  • People who have signs that their pancreatic cancer has come back in the same area or has spread to other parts of the body.
  • People who have had another cancer within the past 5 years, except for certain treated cancers that are generally considered low-risk (such as some cervical or vulvar pre-cancers, treated skin cancer, or certain early-stage bladder tumours — confirm with trial site).
  • People who have a known allergy or serious sensitivity to any of the chemotherapy drugs used in this trial (5-fluorouracil, oxaliplatin, irinotecan, or related compounds).
  • People who are known to have a deficiency of an enzyme called DPD (dihydropyrimidine dehydrogenase), which affects how the body breaks down certain chemotherapy drugs.
  • People who have taken part in another experimental drug study within the 4 weeks before starting this trial, or who would be taking part in another experimental drug study at the same time (except for other clinical trials where the same standard chemotherapy combination is being used).
  • People who have certain serious health conditions, including a heart attack in the past 6 months, significant heart failure (classified as NYHA Class III or IV), or an active infection currently requiring intravenous (IV) antibiotics.
  • People who have a history of, or are suspected to have, a liver condition called Gilbert's syndrome, or who carry a specific genetic variation (UGT1A1*28) that affects how the body processes one of the chemotherapy drugs (confirm with trial site).
  • People who already have moderate to severe nerve damage causing numbness, tingling, or pain (known as peripheral neuropathy, grade 2 or higher).
  • People who have had major surgery, an open biopsy, or a serious physical injury within the 4 weeks before starting the trial.
  • People who are not able or not willing to stop taking the antifungal medication ketoconazole or the herbal supplement St John's Wort during the trial.
  • People who are pregnant or currently breastfeeding.
  • People whose personal, family, social, or geographic circumstances may make it difficult to follow the study schedule and attend required appointments (confirm with trial site).

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 23 July 2026
Phase 2: approximately ~30% 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: Ashwin Somasundaram, MD, University of North Carolina, Chapel Hill

Phone: 919-966-4432

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 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
12 June 2019
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype

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: 23 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