BridgeMD
New treatment option for Borderline Resectable Pancreatic Ductal Adenocarcinoma
Official title NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial
ClinicalTrials.gov ID: NCT06821997
What this study is testing
What is Fluorouracil?
Fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for borderline resectable pancreatic ductal adenocarcinoma.
Also referred to as 5 Fluorouracil, 5 Fluorouracilum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years of age
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National...
- Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors
- Platelet count ≥ 100,000 cells/uL
You likely can't join if
- Patients who have had previous chemotherapy or radiotherapy for PDAC
- Patients with resectable, unresectable, or metastatic PDAC
- Presence of germline glucuronosyltransferase (UGT) 1A1 (\ 28 or \ 6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\ 2A [rs3918290...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
See the full eligibility criteria
- Age ≥ 18 years of age
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria
- Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors
- Platelet count ≥ 100,000 cells/uL
- Hemoglobin ≥ 9 g/dL
- Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatine clearance of \> 30 mL/min (per Cockroft-Gault equation)
- Plasma albumin ≥ 3 g/dL
- Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect...
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form (ICF) prior to receiving any study related...
- Patients who have had previous chemotherapy or radiotherapy for PDAC
- Patients with resectable, unresectable, or metastatic PDAC
- Presence of germline glucuronosyltransferase (UGT) 1A1 (\ 28 or \ 6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\ 2A [rs3918290, c.1905+1G\>A, IVS14+1G\>A], c.2846A\>T [rs67376798, D949V], c.1679T\>G...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.