Tailored drugs aim to stop pancreatic cancer's return after surgery
NCT ID NCT06228599
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving patients drugs that match their tumor's unique molecular profile can prevent pancreatic cancer from coming back after surgery. It includes 40 adults whose cancer was removed but who are at high risk of recurrence. Researchers will track how long patients stay cancer-free and monitor side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 1. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L. 2. Platelet count ≥ 75,000/mm\^3 (125 × 109/L). 3. Hemoglobin (Hgb) ≥ 8 g/dL. 4. aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamate-pyruvate transaminase (SGPT) ≤ 5 × upper limit of normal range (ULN). 7. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3. 8. At the time of treatment, patient should be off other anti-tumor agents for at least five half-lives of the agent or three weeks from the last day of treatment, whichever is shorter. 9. Able to swallow and retain oral medication, if needed. 10. Pregnancy It is not known what effects matched therapy has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Nonsterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a female of childbearing potential (FCBP), defined as all female patients that were not in post-menopause for at least one year or are surgically sterile, OR * An FCBP must have a negative serum pregnancy test and agree to use at least one form of pregnancy prevention during the study for at least one month after treatment discontinuation unless otherwise noted by the agent(s) USPI, which the FCBP must follow. Male participants: A male participant, even if surgically sterilized (i.e., status post vasectomy), must use a form of barrier pregnancy prevention approved by the investigator or treating physician during the study and for at least one month after treatment discontinuation and refrain from donating sperm during this period unless otherwise noted by the agent(s) USPI, which the male participant must follow. 11. Patient must be presented at the Molecular Tumor Board (MTB) and agree to receive the MTB-recommended therapy. 12. Ability to understand a written informed consent document, and the willingness to sign it. 1. Patients presented at the MTB prior to signing consent are eligible to be on study. Patients do not need to be presented again at the MTB prior to starting therapy on trial unless six months elapse between consent and start of study treatment. Exclusion Criteria: A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert Hospital & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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