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The purpose of this study is to evaluate the efficacy of anti-diabetic treatment on improving the overall survival for metastatic pancreatic cancer patients complicated by diabetes receiving gemcitabine and nab-paclitaxel chemotherapy.
About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.
Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of anti-diabetic treatment in type 3c diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active anti-diabetic treatment | Experimental |
| |
| Regular anti-diabetic treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel | Drug | 120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): | Time from randomization to death from any cause | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from enrollment to first tumor progression. | 2 months |
| Blood Glucose Control | Changes in fasting blood glucose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Tumor Marker Changes: | Changes in CA19-9, CEA, and CA125 levels compared to baseline | One month |
Inclusion Criteria:
Exclusion Criteria:
• History of other malignancies requiring anti-cancer therapy within 2 years prior to enrollment (except treated Stage I prostate cancer, in situ cervical cancer, in situ breast cancer, etc.);
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huanyu Xia, MD | Contact | +86868621641755 | luoguopei@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guopei Luo, MD | Shanghai Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38050737 | Result | Zhu X, Xiao Z, Liu H, Zhang P, Deng S, Ding L, Feng J, Luo J, Ni Q, Luo G, Yu X. Pancreatic Cancer: An Exocrine Tumor With Endocrine Characteristics. Ann Surg. 2024 Dec 1;280(6):e17-e25. doi: 10.1097/SLA.0000000000006168. Epub 2023 Dec 5. |
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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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D007004 | Hypoglycemic Agents |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine (1000 mg/m2) | Drug | (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks |
|
| Anti-Diabetics | Other | Metformin, insulin or other anti-diabetic treatments |
|
| Active treatment and monitoring | Other | Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation. |
|
| One month |
| Rate of HbA1c Control | Changes in glycated hemoglobin compared to baseline. | One month |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |