PDAC - Pancreatic Ductal AdenocarcinomaPhase 2NCT05947825
Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
A Phase 2 study testing Combination of sitagliptin+ gemcitabine + nab-paclitaxel in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Combination of sitagliptin+ gemcitabine + nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
- Total bilirubin level ≤ 2 x ULN
- 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).
- 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
- Life expectancy estimated at ≥ 3 months
Who cannot join
- With any cancer other than PDAC in recent 5 years;
- With myocardial infarction;
- Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
- LVEF<50%
- History of hemorrhage or thromboembolism in the last 6 months
- Psychiatric history
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- Pregnant or breastfeeding
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Autoimmune disease
- Uncontrolled active infection
- Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study of Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel as a First-line Treatment for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
The purpose of this study is to determine the efficacy of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
Read the detailed description
This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel.
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Being tested
- Combination of sitagliptin+ gemcitabine + nab-paclitaxel
- Keywords
- PDAC, sitagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of sitagliptin+ gemcitabine + nab-paclitaxelDrug
Drug1: Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment.
Drug2: Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment.
Drug3: Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 125 mg/m2 depending on cohort assignment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel | Experimental | Drug: Sitagliptin Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment.
Drug: Gemcitabine Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment.
Drug: Nab-Paclitaxel Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 125 mg/m2 depending on cohort assignment. Receives: Drug: Combination of sitagliptin+ gemcitabine + nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival time
Rrogression-free survival time of PDAC patients
Measured: from start of treatment until progression or last known follow up (i.e up to 2 years)
Secondary outcomes (4)
Objective Response Rate
Objective Response Rate
Measured: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1
Frequency of adverse events in the safety evaluable population
Frequency of adverse events in the safety evaluable population
Measured: Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)
Median Overall Survival (mOS) of the treated population
Median Overall Survival (mOS) of the treated population
Measured: from start of treatment until death or last known follow up (i.e up to 2 years)
Disease control rate (DCR)
Disease control rate (DCR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jul 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, Dr., Principal investigator, Tianjin Medical University affiliated Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947825
- Sponsor's protocol ID
- SITGEM-CARE
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu J, Shi S, Li M, Fang Q, Yan J, Zhang Y, Liu Z, Li Z, Wang L, Lv Z, Wang Y, Wang T, Zhao Z, Ma X, Zhang J, Xie G, Sun H, Zhao N, Chang A, Feng Y, Wang H, Chen X, Liang Y, Zhao T, Wang J, Ma W, Gao C, Gao S, Wang B, Xie Y, Zhou T, Yang C, Wang X, Hao J. Sitagliptin, a repurposed diabetes drug, overcomes gemcitabine resistance in pancreatic cancer via ribonucleotide reductase inhibition: SITGEM-CARE phase 2 trial. Signal Transduct Target Ther. 2026 Nov 3;11(1):483. doi: 10.1038/s41392-026-02966-0.
PubMed 42971953
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel as a First-line Treatment for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05947825
- Acronym / sponsor ID
- SITGEM-CARE
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC, sitagliptin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
Detailed description
This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel | Experimental | Drug: Combination of sitagliptin+ gemcitabine + nab-paclitaxelDrug: Sitagliptin Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment. Drug: Gemcitabine Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment. Drug: Nab-Paclitaxel Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 125 mg/m2 depending on cohort assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN)
- Total bilirubin level ≤ 2 x ULN
- 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).
- 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
Key exclusion criteria (11 listed)
- With any cancer other than PDAC in recent 5 years;
- With myocardial infarction;
- Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment)
- LVEF<50%
- History of hemorrhage or thromboembolism in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of sitagliptin+ gemcitabine + nab-paclitaxelDrug1: Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment. Drug2: Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment. Drug3: Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 125 mg/m2 depending on cohort assignment. | Drug | Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel |
Primary outcome
Progression-free survival time
Time frame: from start of treatment until progression or last known follow up (i.e up to 2 years)
Rrogression-free survival time of PDAC patients
4 secondary outcomes
Objective Response Rate
Time frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) Using RECIST 1.1
Frequency of adverse events in the safety evaluable population
Time frame: Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years)
Median Overall Survival (mOS) of the treated population
Time frame: from start of treatment until death or last known follow up (i.e up to 2 years)
Disease control rate (DCR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 42971953Yu J, Shi S, Li M, Fang Q, Yan J, Zhang Y, Liu Z, Li Z, Wang L, Lv Z, Wang Y, Wang T, Zhao Z, Ma X, Zhang J, Xie G, Sun H, Zhao N, Chang A, Feng Y, Wang H, Chen X, Liang Y, Zhao T, Wang J, Ma W, Gao C, Gao S, Wang B, Xie Y, Zhou T, Yang C, Wang X, Hao J. Sitagliptin, a repurposed diabetes drug, overcomes gemcitabine resistance in pancreatic cancer via ribonucleotide reductase inhibition: SITGEM-CARE phase 2 trial. Signal Transduct Target Ther. 2026 Nov 3;11(1):483. doi: 10.1038/s41392-026-02966-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jihui Hao, Dr. principal investigator
Tianjin Medical University affiliated Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of sitagliptin+ gemcitabine + nab-paclitaxel in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival time (time frame: from start of treatment until progression or last known follow up (i.e up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.