Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination of sitagliptin+ gemcitabine + nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: PDAC - Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Combination of sitagliptin+ gemcitabine + nab-paclitaxel
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.
Primary outcome measures
- Progression-free survival time [Time frame: from start of treatment until progression or last known follow up (i.e up to 2 years)]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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:
- 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
Exclusion criteria
- 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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute & Hospital — Tianjing
Identifiers
NCT: NCT05947825 · SITGEM-CARE