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2023-10-01
2026-09-30
2027-03-31
20
NCT05903703
First People's Hospital of Hangzhou
First People's Hospital of Hangzhou
INTERVENTIONAL
Canagliflozin With Gemcitabine in Pancreatic Carcinoma
Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
N/A
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 |
|---|---|---|
2023-05-19 | N/A | 2023-06-11 |
2023-06-11 | N/A | 2023-06-15 |
2023-06-15 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Canagliflozin and Gemcitabine | DRUG: Canagliflozin and Gemcitabine
|
| ACTIVE_COMPARATOR: standard cisplatin | DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluation the clinical complete response (CR) at 6 weeks intervals | The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared | 18 weeks |
| Evaluation the clinical partial response (PR) at 6 weeks intervals | the overall reduction in the longest diameter of the tumor focus is > 50% and it can be maintained for at least 4 weeks, with no new focus emerging | 18 weeks |
| Evaluation the clinical stable disease (SD) at 6 weeks intervals | the overall reduction or increase of the longest diameter of the tumor lesion is < 50% or < 25%, and the duration is > 4 weeks; no new lesion appears | 18 weeks |
| Evaluation the clinical disease progression (PD) at 6 weeks intervals | the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears | 18 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hongzhang Shen Phone Number: 057156005600 Email: sakshen@126.com |
Study Contact Backup Name: Xiaofeng Zhang Phone Number: 057156005600 Email: |
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
