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Gene test may guide smarter chemo for pancreatic cancer

NCT ID NCT07748611

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This phase II trial tests whether choosing chemotherapy based on a specific gene mutation (SMAD4) can improve outcomes for people with pancreatic cancer that is or may be surgically removable. The SMAD4 gene normally acts as a brake on tumor growth, but when it's mutated, tumors can be more aggressive and resistant to standard treatments. Instead of a one-size-fits-all approach, the trial assigns patients to either gemcitabine with nab-paclitaxel or FOLFIRINOX based on their tumor's SMAD4 status, aiming to increase the chance of complete surgical removal. The study enrolls about 125 participants and will measure how many achieve successful surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy regimens (gemcitabine with nab-paclitaxel, or FOLFIRINOX) chosen based on SMAD4 gene mutation status
What this could lead to
If successful, this approach could personalize pancreatic cancer treatment, potentially increasing the chance of successful surgery and improving long-term outcomes.
What could go wrong
This is an early-phase pilot study, so results may not apply broadly. The treatment is still experimental, and chemotherapy carries significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have histologically confirmed pancreas ductal adenocarcinoma * Most recent cross-sectional imaging of the chest, abdomen and pelvis will be used to rule out distant metastases (this will have been completed within standard of care timelines which will typically fall within 90 days of registration) * Patients must have undergone next generation sequencing (NGS) testing on the pre-treatment tumor tissue and must have either SMAD4 mutant or SMAD4 wild-type mutation identified before consenting for this study * Note: Before consenting to this study, standard of care NGS procedure will be performed on pre-treatment tumor biopsies that are routinely collected through endoscopic biopsy specimens (in-house Oncomine Precision NGS). The results will be documented for this study from clinic notes * Patients must have resectable/borderline-resectable disease * Note: National Comprehensive Cancer Network (NCCN) definitions of resectability will be used * Patients must be treatment-naïve and clinically fit and eligible for either FOLFIRINOX or gemcitabine/nab-paclitaxel chemotherapy regimens (per treating physician's determination) * Patients must be ≥ 18 years of age * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients must have adequate organ and bone marrow function as determined by the treating physician to be considered to be clinically fit for the physician-determined chemotherapy regimen * Patients must agree to use adequate contraception: (e.g. hormonal or barrier method of birth control for a patient of child-bearing potential (POCBP), prior to study entry, and for the duration of study participation. Should a female patient, or a female partner of a patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study doctor immediately. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through the time period indicated for standard of care drugs , after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) * POCBP must have a negative pregnancy test prior to registration on study * Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements Exclusion Criteria: * Patients with the presence of any of the following genetic or molecular abnormalities: * Mismatch repair (MMR)-deficiency/Lynch syndrome * High-frequency microsatellite instability (MSI-H) * Homologous recombination deficiency (HRD) * Patients who are currently participating in another study and receiving a study drug * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0 * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (per treating physician's determination) * Patients who are pregnant or nursing * Patients who have an uncontrolled intercurrent illness (as determined by treating physician), including, but not limited to any of the following: * Hypertension that is not controlled on medication * Active infection requiring treatment * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Patient with presence of any concurrent medical or psychiatric condition/social situations which would make them inappropriate candidates for entry into this study or that would limit compliance with study requirements, or would compromise the patient's safety or study endpoints, in the treating investigator's judgment

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

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Other studies related to the condition(s) this trial covers.