Can chemo before surgery make pancreatic cancer removable?
NCT ID NCT06132087
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving chemotherapy first can shrink pancreatic tumors that have grown into nearby arteries, making them safe to remove with surgery. Researchers want to see if this approach can completely remove the cancer without leaving any behind. Only 2 people are taking part in this early pilot study.
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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 2 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 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 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: * Histologic or cytologic proof of pancreatic adenocarcinoma * Locally advanced, stage III (T4NxM0) and unresectable by National Comprehensive Cancer Network (NCCN) Guidelines prior to perioperative chemotherapy * Patients must have measurable disease at diagnosis per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * At least 4 cycles of perioperative chemotherapy (gemcitabine \[Gem\]/nab-paclitaxel or fluorouracil, irinotecan, leucovorin and oxaliplatin \[FOLFIRINOX\]) received with no evidence of progression on restaging scans per RECIST 1.1 * Age ≥ 18 years * Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 * Absolute neutrophil count ≥ 1,500/mcL * Platelets ≥ 100,000/mcl * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) if no biliary stenting has been done or 2.0 x ULN if patient is status post (s/p) biliary stenting or two down trending values * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \[SPGT\]) ≤ 2.5 X ULN * Creatinine (Cr) ≤ 1.5 mg/dL or Cr clearance ≥ 30 mL/min (as estimated by Cockcroft Gault) * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patient with known distant metastases * Patients who have not recovered from adverse events of chemotherapy due to agents administered more than 4 weeks earlier * Patients who have progressed on 2 prior systemic chemotherapy lines or received prior radiotherapy for pancreatic cancer * Patients may not be receiving any other investigational agents * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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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.
Contacts and locations
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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