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OncoMatch/Clinical Trials/NCT03977233

Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer

Is NCT03977233 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Oxaliplatin and Leucovorin for pancreatic ductal adenocarcinoma (pdac).

Phase 2RecruitingUNC Lineberger Comprehensive Cancer CenterNCT03977233Data as of May 2026

Treatment: Oxaliplatin · Leucovorin · Irinotecan Hydrochloride · 5-FUThis is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed). However, not all types of PDACs are resectable, especially if they are close to important structures like blood vessels or intestines. These types of PDACs are treated with chemotherapy such as FOLFIRINOX. Research studies showed that chemotherapy after surgical resection of PDAC tumors reduced the risk of the cancer returning. Chemotherapy is used to treat PDAC that has not spread outside of the pancreas and is not resectable. FOLFIRINOX is a chemotherapy treatment that combines multiple chemotherapeutic agents, including oxaliplatin, leucovorin, irinotecan, and 5-FU. Patients receive these agents by intravenous infusion. Of these drugs, 5-FU requires you to return home with a chemotherapy pump that will deliver chemotherapy over 46 hours. This regimen has been studied in pancreatic cancer that has been removed with surgery as a method for preventing the cancer from returning. Studies showed FOLFIRINOX chemotherapy reduced the risk of cancer returning and increased patients survival. In this study, researchers want to know if FOLFIRINOX chemotherapy given before surgery will make the cancer easier to remove with surgery and increase the chances of the cancer staying away after surgery. Researchers have shown that pancreatic cancers are not all the same when you look at the DNA and RNA that is inside a pancreatic cancer cell. Depending on the expression of different genes in a cancer cell, some pancreatic cancers may respond differently to chemotherapy. In this study researchers want to know if FOLFIRINOX chemotherapy can change the genetic profile of the cancer. This will be studied by obtaining a biopsy of the cancer before the start of chemotherapy, and after 8 treatments of chemotherapy. They will also study cancer cells that will be collected from blood samples.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Excluded: DPYD enzyme deficiency

known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

Excluded: UGT1A1 *28 homozygosity

known homozygosity for UGT1A1*28 polymorphism

Disease stage

Required: Stage RESECTABLE, BORDERLINE RESECTABLE, III

Excluded: Stage IV

Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) resectable, borderline resectable or unresectable locally advanced PDAC

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

Kidney function

Liver function

Subject has adequate organ function at study entry.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina

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