Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

NCT05634720 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00112285
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes. The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

PDAC; HA chemotherapy; FUDR; oxaliplatin

Outcome Measures

Primary Outcomes (2)

• Safety of HA Chemotherapy for PDAC

  Number of adverse events

  30 days postoperatively

• Feasibility of HA Chemotherapy for PDAC

  Number of enrolled patients that receive HA chemotherapy followed by planned standard-of-care surgical resection

  30 days post-operatively

Secondary Outcomes (3)

• Disease Free Survival

  3 years post-operatively

• Liver metastasis-free survival

  3 years post-operatively

• Overall Survival

  3 years post-operatively

Study Arms (1)

PDAC with HA Chemotherapy

EXPERIMENTAL

Patients eligible to receive systemic chemotherapy and surgical resection will have the investigational treatment, which is neoadjuvant HA chemotherapy prior to resection.

Drug: HA Chemotherapy

Interventions

HA Chemotherapy DRUG

Patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy (FUDR/oxaliplatin delivered via the Hepatic Artery).

PDAC with HA Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if they meet all of the following criteria:
• Histologically or cytologically confirmed diagnosis of PDAC, which is clinically staged as either resectable or borderline resectable after multidisciplinary evaluation.
• Age \>= 18 yo
• ECOG Performance Status 0-1
• Eligibility for FOLFIRINOX as determined by medical oncology.
• Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study and must have a negative serum or urine pregnancy test within 1 week of neoadjuvant HA chemotherapy as well as during adjuvant chemotherapy as per SOC practices.
• Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
• Expected survival \>3 months.
• Adequate laboratory parameters and organ function, namely:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin (Hgb) ≥ 8 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• ALT and AST ≤ 2.5 x ULN
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance (estimated) ≥ 50 cc/min by Cockroft-Gault Formula (Appendix C)

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• Hepatic arterial anatomy not amenable to percutaneous access, and/or delivery of HA chemotherapy, as determined by the principal investigator and treating interventional radiologist. These may include any of the following: celiac or superior mesenteric artery occlusion; accessory or replaced hepatic arteries that cannot be ligated, divided, or embolized per the treating surgeon/interventional radiologist and would thus require more than two hepatic artery branch cannulations to treat the entire liver; any other variant anatomy deemed to have a risk of non-target GI infusion or incomplete hepatic perfusion.
• CA 19-9 \>500 within 4 weeks of planned surgical resection.
• Pregnancy or breastfeeding.
• Not willing to use an effective method of birth control.
• History of other carcinomas diagnosed within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, curatively treated localized thyroid cancer, or localized prostate cancer treated curatively with no evidence of biochemical or imaging recurrence.
• Liver cirrhosis.
• Prior liver surgery including partial hepatectomy or transplantation.
• Active hepatitis or unresolved biliary obstruction at the time of diagnostic laparoscopy, as evidenced by:
• Total bilirubin \> 1.5 x ULN
• ALT and AST \> 2.5 x ULN
• Recent or current active infectious disease requiring systemic antivirals, antibiotics or antifungals, or treatment within 2 weeks prior to the start of study drug, including acute or chronic active hepatitis B or hepatitis C infection, or uncontrolled HIV/AIDS. Patients with well controlled HIV are permitted. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease) are eligible.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the start of study or anticipation of need for major surgical procedure during the course of the study other than surgical resection of the pancreatic tumor.
• Serious, non-healing wound, ulcer, or bone fracture.
• History of allogenic hematopoietic stem cell transplantation.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Study Officials

• Daniel Nussbaum, MD

  Duke Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. All patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: January 2, 2024
• Primary Completion: November 18, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available within 6 months of data analysis and will be available for a minimum of 25 years.
• Access Criteria: You will not attempt to identify any individuals included in the data or otherwise infringe the privacy or confidentiality rights of individuals discovered inadvertently or intentionally in the data If you should identify anyone unintentionally, you will contact the RDR at datamanagement@duke.edu You will abide by the Creative Commons license conditions applied to the data (if any). You will properly cite the data by including a data citation in any publication or presentation resulting from use of the data. Content within the files are governed by the RDR Data Deposit Agreement. Data are offered with no warranty or claim of fitness for any purpose. In no event shall Duke University be liable for any actual, incidental or consequential damages arising from use of these files. If you discover that a link is broken or that you are not able to download the files you need, please contact datamanagement@duke.edu.

Locations

US (1)