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Alkylating agents

Hepatic Artery Chemotherapy for Pancreatic Cancer

Phase 4

Recruiting

Led By Daniel Nussbaum, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status 0-1

Age >= 18 years old

Must not have

Concurrent severe and/or uncontrolled medical conditions

Serious, non-healing wound, ulcer, or bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post-operatively

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will investigate the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy to standard-of-care treatment for localized PDAC to better determine best sequence of surgery and chemotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from HA chemotherapy may include reactions at the infusion site, possible damage to liver tissue due to targeted delivery of drugs via hepatic artery, general side effects from chemotherapeutic agents like fatigue, nausea/vomiting, low blood counts leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I am using birth control and my pregnancy test was negative.

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My blood tests and organ functions are within normal ranges.

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My pancreatic cancer is confirmed and considered operable after evaluation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or uncontrolled health conditions.

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I have a serious wound or fracture that is not healing.

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I have hepatitis B or C.

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I am currently taking medication for an infection.

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I am on long-term steroids or medications that suppress my immune system.

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I have liver cirrhosis.

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I do not have active hepatitis or unresolved blockage in my bile ducts.

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I have had a stem cell transplant from a donor.

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My liver's blood vessels cannot be accessed with a needle through the skin.

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I am not willing to use birth control.

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I have not had major surgery or a serious injury in the last 28 days.

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My CA 19-9 levels were above 500 close to my surgery date.

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I haven't had any other cancers in the last 2 years, except for those considered cured.

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I have had liver surgery, such as part of my liver removed or a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of HA Chemotherapy for PDAC

Safety of HA Chemotherapy for PDAC

Secondary study objectives

Disease Free Survival

Liver metastasis-free survival

Overall Survival

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PDAC with HA ChemotherapyExperimental Treatment1 Intervention

On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.

0 / 19Eligibility criteria met