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2023-07-30
2024-08-01
2024-08-01
30
NCT05947825
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
INTERVENTIONAL
Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
The purpose of this study is to determine the safety and tolerance of sitagliptin combined with gemcitabine and albumin-bound paclitaxel in subjects with locally advanced and metastatic pancreatic ductal adenocarcinoma.
This is a single-institution, prospective, open, one-armed phase Ⅱ clinical trial of sitagliptin combined with gemcitabine and nab-paclitaxel. This study will enroll 30 PDAC patients over 12-15 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-07-09 | N/A | 2023-07-09 |
2023-07-09 | N/A | 2023-07-17 |
2023-07-17 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel 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 depend | DRUG: Combination of sitagliptin+ gemcitabine + nab-paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival time | Rrogression-free survival time of PDAC patients | from start of treatment until progression or last known follow up (i.e up to 2 years) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate | 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 | 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 | 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) | 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jihui Hao, Dr. Phone Number: 86-022-23340123 Email: haojihui@tjmuch.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
