Mini-Tumors in a dish may guide pancreatic cancer treatment
NCT ID NCT07683845
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study investigates whether tiny, lab-grown copies of a patient's own pancreatic tumor—called organoids—can predict how well standard chemotherapy will work. Researchers will collect tumor samples from 164 people with pancreatic cancer, grow organoids from them, and test different chemotherapy drugs in the lab. The results will be compared to how each patient actually responds to treatment. If the organoid tests match clinical outcomes, this could lead to a personalized tool that helps doctors pick the right chemotherapy from the start, avoiding ineffective treatments and their side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this approach could help doctors choose the most effective chemotherapy for each pancreatic cancer patient, reducing trial-and-error and improving outcomes.
- What could go wrong
- This is an observational study, not a treatment trial. The organoid test may not accurately predict real patient responses, and results may not apply to all patients.
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.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population comprises treatment-naïve patients aged 18-75 years with histologically confirmed pancreatic ductal adenocarcinoma (PDAC) scheduled to receive first-line chemotherapy for borderline resectable, locally advanced, or metastatic disease. Eligible patients must have measurable disease per RECIST 1.1, ECOG performance status 0-2, life expectancy ≥3 months, and adequate organ function. Patients must provide sufficient fresh tumor tissue from surgery or biopsy (EUS-FNB 19G/22G) with tumor cell content and viability \>50%. Approximately 164 patients will be screened to achieve 80 evaluable cases, accounting for follow-up rate of 90%, organoid culture success rate of 85%, and exclusions due to non-PDAC pathology or non-first-line treatment. All participants must sign informed consent and comply with follow-up.
- Ages
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18 to 75 years
- 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: * Age 18-75 years, both sexes * Pathologically confirmed pancreatic ductal adenocarcinoma (PDAC) in treatment-naïve patients * Ability to obtain sufficient fresh tumor tissue samples for organoid establishment through surgery or biopsy * Planned to receive neoadjuvant therapy for borderline resectable disease, conversion therapy for locally advanced disease, or first-line therapy for metastatic disease, using single-agent or combination chemotherapy * At least one measurable lesion per RECIST 1.1 criteria * ECOG performance status 0-2 * Life expectancy ≥3 months * Adequate organ and bone marrow function: hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; total bilirubin ≤1.5×ULN (or ≤3×ULN with biliary obstruction); ALT/AST ≤2.5×ULN (or ≤5×ULN with biliary obstruction); serum creatinine ≤1.5×ULN or CrCl \>60 mL/min * Willing to sign informed consent, good compliance, and able to comply with follow-up Exclusion Criteria: * Sample quantity, quality, or preservation does not meet requirements * Expected transport time \>24 hours (including samples stored overnight before delivery) * Organoid culture failure or testing quality control failure * Inability to tolerate chemotherapy regimens * Severe comorbidities, uncontrolled conditions, or active infections * Pregnancy or breastfeeding * History of severe autoimmune diseases * Any unstable condition that may compromise patient safety or compliance * Deemed unsuitable for inclusion by the investigator
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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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Ruijin Hospital
RECRUITINGShanghai, Shanghai Municipality, 200025, China
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