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| Name | Class |
|---|---|
| College of Pharmaceutical Sciences at Zhejiang University | UNKNOWN |
| The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin and Gemcitabine | Experimental |
| |
| standard cisplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin and Gemcitabine | Drug | on the first, 8th and 15th day of treatment, patients were given intravenous drip of 1000mg/m2 gemcitabine, and 21 days was a course of treatment, lasting for 6 courses. Take 400mg canagliflozin orally every day, and continue to use it until the end of chemotherapy. According to the patient's tolerance to disulfiram, the dose of canagliflozin can be re-evaluated during the treatment, and the highest dose is 125mg per day. The clinical symptoms, signs and adverse reactions of patients were observed, and the treatment effect of patients was evaluated after two consecutive cycles with 4 weeks as a cycle |
| 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 |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhang Shen | Contact | 057156005600 | sakshen@126.com | |
| Xiaofeng Zhang | Contact | 057156005600 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou first people's Hospital | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Gemcitabine | Drug | on the first, 8th and 15th day of treatment, patients were given 1000mg/m2 gemcitabine intravenously, and 21 days was a course of treatment, lasting for 6 courses. |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |