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RECRUITINGNA

Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence

NCT06228599•Medical College of Wisconsin

Summary

This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.

Detailed Description

This is a prospective, open-label, therapeutic interventional investigation designed to interrogate the efficacy and safety of personalized matched therapy in pancreatic cancer patients who have completed all intended multimodal therapy, including resection of the pancreatic cancer tumor. Potential participants must have their tumor tissue or blood molecularly profiled with the results discussed by the Molecular Tumor Board, whether convened in person, virtually (e.g., WebEx), or in an electronic forum (e.g., email). Only those patients who agree to receive the Molecular Tumor Board-recommended matched therapy (i.e., study treatment) will be eligible and enrolled on the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years.
•2. Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
•3. Pancreatic tumor is surgically removed and
•1. patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
•2. patient is ineligible for or refuses multimodal therapy.
•4. Patient has one of the following:
•1. Post-surgical cancer antigen (CA) 19-9 elevation (\> 35 U/mL at least 6 weeks post-surgical resection) in the setting of bilirubin \< 2 mg/dL (unless bilirubin elevation is consistent with Gilbert's syndrome) OR
•2. High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
•5. Patient has no definitive measurable disease recurrence or metastatic disease at the time of first post-surgical imaging (in those with high-risk pathological features) or within four weeks of elevated CA 19-9 value as evidenced by appropriate imaging.
•6. Laboratory values:
+15 more criteria

Exclusion Criteria

•1. CA 19-9 non-producers, unless high-risk pathological features present.
•2. Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
•3. Radiographic evidence of metastatic disease.
•4. Inability to ingest study drugs by mouth.
•5. Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
•6. Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
•7. Patient has undergone or planned major surgery other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of study therapy.
•8. Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
•9. Uncontrolled concurrent illness, including, but not limited to, unstable angina pectoris, uncontrolled and clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•10. Is pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention.

Locations (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

February 29, 2024

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

April 27, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreas Cancer

Interventions

Treatment Plan

OTHER

Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505 cccto@mcw.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence

Inclusion Criteria

Exclusion Criteria

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