Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients

NCT05947825 | Enrolling By Invitation Phase 2

• 1 other identifier: SITGEM-CARE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

PDAC; sitagliptin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  from start of treatment until death or last known follow up (i.e up to 2 years)

• Disease control rate (DCR)

  2 years

Study Arms (1)

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.

Drug: Combination of sitagliptin+ gemcitabine + nab-paclitaxel

Interventions

Combination of sitagliptin+ gemcitabine + nab-paclitaxel DRUG

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.

Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjing, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel

Study Officials

• Jihui Hao, Dr.

  Tianjin Medical University affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)