Actively Recruiting
Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
Led by Medical College of Wisconsin · Updated on 2026-05-05
40
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed pancreatic cancer excluding neuroendocrine histology
- Surgical removal of pancreatic tumor with either completed multimodal therapy (neoadjuvant, sandwich, or adjuvant chemotherapy with or without radiation) or ineligibility/refusal of such therapy
- Presence of either post-surgical cancer antigen (CA) 19-9 elevation (> 35 U/mL at least 6 weeks after surgery) with bilirubin < 2 mg/dL (unless consistent with Gilbert's syndrome) or high-risk pathological features such as positive surgical margin or lymph node involvement
- No measurable disease recurrence or metastatic disease on first post-surgical imaging or within four weeks of CA 19-9 elevation imaging
- Laboratory values including ANC ≥ 1.0 × 10⁹/L, platelet count ≥ 75,000/mm³ (125 × 10⁹/L), hemoglobin ≥ 8 g/dL, AST and ALT ≤ 5 times upper limit of normal
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 3
- Off other anti-tumor agents for at least five half-lives or three weeks before treatment
- Ability to swallow and retain oral medication if needed
- Female participants must not be pregnant or breastfeeding and use effective contraception if of childbearing potential
- Male participants must use barrier contraception and avoid sperm donation during treatment and for one month after
- Presented at Molecular Tumor Board and agree to receive recommended therapy
- Ability to understand and sign informed consent
You will not qualify if you...
- CA 19-9 non-producers without high-risk pathological features
- Receiving other investigational agents for pancreatic ductal adenocarcinoma
- Evidence of metastatic disease on imaging
- Unable to ingest study drugs by mouth
- Diarrhea greater than 6 bowel movements per day postoperatively despite maximal medical therapy
- Active, untreated, or uncontrolled infections requiring intravenous therapy
- Major surgery other than diagnostic surgery within four weeks prior to study treatment
- History of allergy or hypersensitivity to study drugs or excipients
- Uncontrolled illnesses such as unstable angina, significant cardiac arrhythmias, or psychiatric/social issues limiting study compliance
- Pregnant or breastfeeding or any patient with childbearing potential not using adequate pregnancy prevention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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