Hepatic Artery Chemotherapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Duke University
Stay on your current meds
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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).
What safety data exists for hepatic artery chemotherapy in pancreatic cancer?
The safety of hepatic artery infusion (HAI) chemotherapy for pancreatic cancer has been evaluated in several studies. One study assessed HAI chemotherapy after pancreatectomy for pancreatobiliary cancer, focusing on safety. Another study reported on HAI of floxuridine combined with systemic chemotherapy for pancreatic cancer liver metastases, noting that while there were some hematologic adverse events like leukocytopenia and anemia, no life-threatening toxicities were observed. However, catheter complications were common. Overall, HAI chemotherapy is considered useful and safe for treating liver-confined malignancies, with increased regional efficacy and lower systemic side effects.
5681011Is the treatment HA Chemotherapy a promising treatment for pancreatic cancer?
Yes, HA Chemotherapy, which involves delivering drugs directly to the liver, shows promise for treating pancreatic cancer that has spread to the liver. It has been effective in treating liver metastases from other cancers, like colorectal cancer, and is being tested for pancreatic cancer with positive results.
124710What data supports the idea that Hepatic Artery Chemotherapy for Pancreatic Cancer is an effective treatment?
The available research shows that Hepatic Artery Chemotherapy (HA Chemotherapy) is being studied for its effectiveness in treating pancreatic cancer that has spread to the liver. One study specifically looked at using a drug called floxuridine (FUDR) with other chemotherapy drugs for this purpose. While the research primarily focuses on liver metastases from colorectal cancer, it suggests that HA Chemotherapy could be beneficial for pancreatic cancer as well. This treatment is considered effective for liver metastases from colorectal cancer, which indicates potential for similar success in pancreatic cancer cases.
347910Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic corticosteroids or immunosuppressive medications, you may need to adjust your treatment. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
This trial is for adults over 18 with localized pancreatic cancer who are fit (ECOG 0-1) and eligible for surgery and chemotherapy. They must have good organ function, agree to use contraception if fertile, and not be pregnant or breastfeeding. Exclusions include recent major surgeries, other interventional trials participation during the study period, severe medical conditions, liver cirrhosis, high CA 19-9 levels before surgery, history of certain cancers within two years or prior liver surgery.Inclusion Criteria
I am fully active or can carry out light work.
I am 18 years old or older.
I am using birth control and my pregnancy test was negative.
My blood tests and organ functions are within normal ranges.
My pancreatic cancer is confirmed and considered operable after evaluation.
Exclusion Criteria
I do not have any severe or uncontrolled health conditions.
I have a serious wound or fracture that is not healing.
I have hepatitis B or C.
I am currently taking medication for an infection.
I am on long-term steroids or medications that suppress my immune system.
I have liver cirrhosis.
I do not have active hepatitis or unresolved blockage in my bile ducts.
I have had a stem cell transplant from a donor.
My liver's blood vessels cannot be accessed with a needle through the skin.
I am not willing to use birth control.
I have not had major surgery or a serious injury in the last 28 days.
My CA 19-9 levels were above 500 close to my surgery date.
I haven't had any other cancers in the last 2 years, except for those considered cured.
I have had liver surgery, such as part of my liver removed or a liver transplant.
Participant Groups
The trial tests single-dose neoadjuvant Hepatic Artery (HA) chemotherapy using FUDR/oxaliplatin in patients with pancreatic cancer scheduled for resection and systemic chemo. It aims to determine the safety of adding HA chemo before standard treatments across different treatment sequences. Patients will be monitored short-term post-surgery then every three months up to three years for survival outcomes.
1Treatment groups
Experimental Treatment
Group I: PDAC with HA ChemotherapyExperimental Treatment1 Intervention
Patients eligible to receive systemic chemotherapy and surgical resection will have the investigational treatment, which is neoadjuvant HA chemotherapy prior to resection.
HA Chemotherapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as FUDR/Oxaliplatin for:
- Colorectal cancer liver metastases
- Unresectable colorectal cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Duke University Health SystemDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
References
Gastric perforation from hepatic artery infusion chemotherapy. [2019]Hepatic artery infusion chemotherapy may result in mucosal inflammation and ulceration, gastrointestinal hemorrhage, pancreatitis and catheter-related vascular injury. We report a patient who developed gastric perforation during hepatic artery infusion chemotherapy. The influence of variations of hepatic artery branching and catheter placement in producing this life-threatening complication is discussed.
Hepatic artery infusion: surgical approach. [2019]Hepatic artery infusion chemotherapy for the treatment of nonresectable liver cancer is gaining popularity among the medical community. A lack of knowledge of the variants in the anatomy of the arterial blood supply to the liver may lead to inadequate hepatic perfusion, or inadvertent perfusion of extrahepatic organs. A review of 70 hepatic artery angiograms on patients referred to the liver program at the Creighton Cancer Center was performed to integrate angiographic findings, surgical techniques, and clinical decision making.
Percutaneous implantation of arterial Port-a-cath via trans-subclavin access. [2004]Hepatic artery infusion is the best choice of treatment for colorectal liver metastases, but it could be suggested for other hepatic tumors or locally advanced pancreatic cancer. The need of a laparotomy for the positioning of the arterial catheter has been the limiting factor for the diffusion of regional treatments.
Hepatic arterial chemotherapy with oxaliplatin, folinic acid and 5-fluorouracil in pre-treated patients with liver metastases from colorectal cancer. [2022]Hepatic arterial chemotherapy (HAC) is an effective treatment of liver metastases from colorectal cancer (CRC). Phase I and II studies have already shown the feasibility and efficacy of intra-arterial oxaliplatin (OXA).
Repetitive short-course hepatic arterial infusion chemotherapy with high-dose 5-fluorouracil and cisplatin in patients with advanced hepatocellular carcinoma. [2022]Hepatic arterial infusion chemotherapy (HAIC) has often been selected as a therapeutic option for patients with advanced hepatocellular carcinoma (HCC). The objective of the current study was to evaluate the efficacy and safety of repetitive HAIC with high-dose 5-fluorouracil (5-FU) and cisplatin given for 3 days in patients with advanced HCC.
Safety and optimal management of hepatic arterial infusion chemotherapy after pancreatectomy for pancreatobiliary cancer. [2013]The purpose of this study was to assess the safety of hepatic arterial infusion (HAI) chemotherapy after pancreatectomy for pancreatobiliary cancer.
Intra-arterial hepatic chemotherapy for unresectable colorectal liver metastases: a review of medical devices complications in 3172 patients. [2021]Hepatic artery infusion (HAI) is indicated to treat unresectable colorectal hepatic metastases, with recent applications as a neoadjuvant or adjuvant treatment. Traditionally performed with the infusion of fluoropyrimidine-based chemotherapy, it has been now tested with oxaliplatin or irinotecan and associated with systemic chemotherapy.
Pilot study of hepatic arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for patients with postoperative liver metastases from pancreatic cancer. [2022]Hepatic metastasis is a common cause of treatment failure after curative resection of pancreatic cancer. We report a pilot study of hepatic arterial infusion (HAI) chemotherapy with gemcitabine and 5-fluorouracil (5-FU) for postoperative liver metastases from pancreatic cancer. Five patients who had undergone curative resection of liver metastases from pancreatic cancer received HAI of gemcitabine and 5-FU between October 2008 and September 2010 at Kanazawa University Hospital. Gemcitabine at a dose of 800 mg was infused over 30 min via a bedside pump. After gemcitabine administration, 250 mg of 5-FU was infused continuously over 24 h on days 1-5, comprising one cycle of therapy. These treatment cycles were continued biweekly. In the evaluation according to RECIST criteria, a partial response was obtained in 2 of the 5 cases, with stable disease being achieved in the remaining 3 cases (response rate, 100%). In 4 of the 5 cases, a decrease in serum tumor marker CA19-9 was observed after 10 HAI treatment cycles. The median time to treatment failure was 10 months (range 3-17). As to adverse events, leukocytopenia was grade 3 in 1 of 4 affected cases and all 5 were anemic, although 4 of the 5 cases had anemia prior to HAI therapy. Grade 2 thrombocytopenia was observed in 2 cases. No nonhematologic events, such as nausea, diarrhea, liver injury and neuropathy, occurred. There were no life-threatening toxicities, but 4 cases (80%) developed catheter complications, and the HAI catheter and subcutaneous implantable port system had to be removed. HAI delivers high doses of chemotherapeutic agents directly into tumor vessels, producing increased regional levels with greater efficacy and a lower incidence/severity of systemic side effects. In conclusion, HAI chemotherapy is useful and safe for the treatment of malignancies confined to the liver.
A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without intravenous bevacizumab, in patients with advanced cancer and predominant liver involvement. [2019]We investigated hepatic arterial infusion (HAI) oxaliplatin combined with capecitabine +/- bevacizumab in advanced cancer with predominant liver involvement.
Hepatic Artery Infusion of Floxuridine in Combination With Systemic Chemotherapy for Pancreatic Cancer Liver Metastasis: A Propensity Score-Matched Analysis in Two Centers. [2022]To evaluate the efficacy of hepatic artery infusion (HAI) of floxuridine (FUDR) in combination with systemic chemotherapy in patients with pancreatic cancer liver metastases (PCLM).
Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). [2022]Interventional hepatic arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) displayed an encouraging safety profile and antitumor activity in a previous phase II trial and a propensity-score-matching study involving patients with locally advanced hepatocellular carcinoma (HCC).