Can chemo before surgery extend lives in pancreatic cancer?
NCT ID NCT07081360
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether giving chemotherapy before surgery helps people with clearly resectable pancreatic head cancer or periampullary cancer live longer than going straight to surgery. The trial enrolls 262 participants and randomly assigns them to either mFOLFIRINOX chemotherapy followed by pancreaticoduodenectomy, or immediate pancreaticoduodenectomy followed by adjuvant chemotherapy. The main goal is to compare overall survival between the two approaches. The study also tracks disease-free survival and local recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neoadjuvant chemotherapy with mFOLFIRINOX, a combination of four chemotherapy drugs given before surgery
- What this could lead to
- If it works, giving chemotherapy before surgery could become a standard option for people whose pancreatic or periampullary tumors are clearly removable, and it might help more patients complete their full chemotherapy plan.
- What could go wrong
- Chemotherapy before surgery can shrink tumors but also carries side effects that may delay or prevent the operation. The trial may show no survival advantage over immediate surgery, and results in this selected group may not apply to all pancreatic cancers.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 262 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Aug 2028
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 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: * Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy). * Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging: No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery . Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease. * Eastern Cooperative Oncology Group (ECOG)=0-1 \& American Society of Anesthesiologists (ASA) score \<4. * Written informed consent. * Medical history without previous pancreatic resection or pancreatic cancer. * Adequate organ function (liver, kidney, bone marrow) (serum creatinine ≤2.0 mg/dL,reference range 0.5-1.20 mg/dL; serum albumin ≥2.5 g/dL, reference range 3.5-5.3; aspartate aminotransferase (AST) ≤95 U/L, reference range 0-38; Alanine aminotransferase (ALT) ≤102 U/L, reference range 0-41; prothrombin time ≤1.8, reference range 0-1.20; partial thromboplastin time ≤1.8, reference range 0.82-1.25; leukocyte count greater than 3.5×109/L, reference range 4.2-9.0; platelet count greater than 100×109/L, reference range 130-400; hemoglobin ≥9 g/dL, reference range 12-16). Exclusion Criteria: * Borderline resectable or locally advanced pancreatic or periampullary cancer. * Tumor at the body or tail of the pancreas. * Distant metastases. * Prior chemotherapy , surgery or radiotherapy for pancreatic cancer. * Severe comorbidities precluding surgery or chemotherapy. * Pregnancy or lactation. * Other neoplastic diseases (malignant)diagnosed in the past 5 years. * Major surgery or traumatic event in the past 28 days.
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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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Liver and GIT hospital , Minia University
RECRUITINGMinya, Minya Governorate, 61519, Egypt
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