Could a common diabetes drug boost chemotherapy against pancreatic cancer?
NCT ID NCT05947825
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This phase 2 trial investigates whether adding sitagliptin, a diabetes medication, to standard chemotherapy (gemcitabine and nab-paclitaxel) can improve outcomes for people with advanced pancreatic cancer that has not been treated before. The study enrolls 30 adults with locally advanced or metastatic pancreatic ductal adenocarcinoma. The main goal is to see if the combination extends the time patients live without their cancer progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sitagliptin combined with gemcitabine and nab-paclitaxel
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for people with advanced pancreatic cancer, potentially extending the time before the disease worsens.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply to all patients. Adding sitagliptin could also increase side effects from chemotherapy.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Sep 2026
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.≥ 18 years old at the time of informed consent 2.Ability to provide written informed consent and HIPAA authorization 3.Untreated locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion) 4.Histologically or cytologically confirmed PDAC 5.Confirmed PDAC that is measurable or evaluable per RECIST 1.1 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 7.Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less 8.Adequate organ function as defined by: 1. Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN) 2. Total bilirubin level ≤ 2 x ULN 3. Creatinine level \< 1.7mg/dL For patients with a Body Mass Index (BMI) \> 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR). 4. Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelets ≥ 80 x 10\^9/L, Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy 5. Life expectancy estimated at ≥ 3 months Exclusion Criteria: 1. With any cancer other than PDAC in recent 5 years; 2. With myocardial infarction; 3. Uncontrolled hypertension (systolic pressure\>150mmHg or diastolic pressure\>100mmHg after treatment) 4. LVEF\<50% 5. History of hemorrhage or thromboembolism in the last 6 months 6. Psychiatric history 7. Pregnant or breastfeeding 8. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung 9. Autoimmune disease 10. Uncontrolled active infection 11. Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Tianjin Medical University Cancer Institute & Hospital
Tianjing, China
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