ACTIVE_NOT_RECRUITING

Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

Conditions

Pancreatic Ductal Adenocarcinoma PDAC HA chemotherapy FUDR oxaliplatin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

Quick Facts

Study Start:2024-01-02

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05634720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically or cytologically confirmed diagnosis of PDAC, which is clinically staged as either resectable or borderline resectable after multidisciplinary evaluation. 2. Age \>= 18 yo 3. ECOG Performance Status 0-1 4. Eligibility for FOLFIRINOX as determined by medical oncology. 5. 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. 6. Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists. 7. Expected survival \>3 months. 8. Adequate laboratory parameters and organ function, namely: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 2. Platelets ≥ 100 x 109/L 3. Hemoglobin (Hgb) ≥ 8 g/dL 4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) 5. ALT and AST ≤ 2.5 x ULN 6. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (estimated) ≥ 50 cc/min by Cockroft-Gault Formula (Appendix C) 9. Provide written, informed consent to participate in the study and follow the study procedures.	1. 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. 2. CA 19-9 \>500 within 4 weeks of planned surgical resection. 3. Pregnancy or breastfeeding. 4. Not willing to use an effective method of birth control. 5. 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. 6. Liver cirrhosis. 7. Prior liver surgery including partial hepatectomy or transplantation. 8. Active hepatitis or unresolved biliary obstruction at the time of diagnostic laparoscopy, as evidenced by: 1. Total bilirubin \> 1.5 x ULN 2. ALT and AST \> 2.5 x ULN 9. 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. 10. 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. 11. Serious, non-healing wound, ulcer, or bone fracture. 12. History of allogenic hematopoietic stem cell transplantation. 13. Known hepatitis B virus (HBV) infection (e.g., positive hepatitis B surface antigen \[HBsAg\]) or hepatitis C virus (HCV) infection (e.g., positive HCV ribonucleic acid \[RNA\]). 14. Chronic treatment with systemic corticosteroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications * Intermittent steroids (\< 10 mg daily prednisone equivalents) may be used on an as needed basis (e.g. for treatment of nausea, anorexia, and fatigue) * Physiologic replacement doses of steroids due to adrenal insufficiency are permitted in the absence of active autoimmune disease. * Topical, inhaled, or intra-articular corticosteroids are allowed. 15. Participation in other interventional research protocols during the screening to 30 day follow up time-point. 16. Concurrent severe and/or uncontrolled medical conditions, which may compromise participation in the study, including impaired heart function or clinically significant heart disease

Inclusion Criteria

Exclusion Criteria

1. Histologically or cytologically confirmed diagnosis of PDAC, which is clinically staged as either resectable or borderline resectable after multidisciplinary evaluation.
2. Age \>= 18 yo
3. ECOG Performance Status 0-1
4. Eligibility for FOLFIRINOX as determined by medical oncology.
5. 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.
6. Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
7. Expected survival \>3 months.
8. Adequate laboratory parameters and organ function, namely:
1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
2. Platelets ≥ 100 x 109/L
3. Hemoglobin (Hgb) ≥ 8 g/dL
4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. ALT and AST ≤ 2.5 x ULN
6. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (estimated) ≥ 50 cc/min by Cockroft-Gault Formula (Appendix C)
9. Provide written, informed consent to participate in the study and follow the study procedures.

1. 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.
2. CA 19-9 \>500 within 4 weeks of planned surgical resection.
3. Pregnancy or breastfeeding.
4. Not willing to use an effective method of birth control.
5. 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.
6. Liver cirrhosis.
7. Prior liver surgery including partial hepatectomy or transplantation.
8. Active hepatitis or unresolved biliary obstruction at the time of diagnostic laparoscopy, as evidenced by:
1. Total bilirubin \> 1.5 x ULN
2. ALT and AST \> 2.5 x ULN
9. 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.
10. 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.
11. Serious, non-healing wound, ulcer, or bone fracture.
12. History of allogenic hematopoietic stem cell transplantation.
13. Known hepatitis B virus (HBV) infection (e.g., positive hepatitis B surface antigen \[HBsAg\]) or hepatitis C virus (HCV) infection (e.g., positive HCV ribonucleic acid \[RNA\]).
14. Chronic treatment with systemic corticosteroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications
* Intermittent steroids (\< 10 mg daily prednisone equivalents) may be used on an as needed basis (e.g. for treatment of nausea, anorexia, and fatigue)
* Physiologic replacement doses of steroids due to adrenal insufficiency are permitted in the absence of active autoimmune disease.
* Topical, inhaled, or intra-articular corticosteroids are allowed.
15. Participation in other interventional research protocols during the screening to 30 day follow up time-point.
16. Concurrent severe and/or uncontrolled medical conditions, which may compromise participation in the study, including impaired heart function or clinically significant heart disease

Contacts and Locations

Principal Investigator

Daniel Nussbaum, MD

PRINCIPAL_INVESTIGATOR

Duke Medical Center

Study Locations (Sites)

Duke University Health System

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Daniel Nussbaum, MD, PRINCIPAL_INVESTIGATOR, Duke Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-01-02

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

PDAC
HA chemotherapy
FUDR
oxaliplatin

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma