Pancreatic Cancer
Conditions
Keywords
diabetes melltus, metastatic pancreatic cancer, type 3c
Brief summary
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.
Detailed description
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.
Interventions
DRUGNab-paclitaxel
120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks
(1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
OTHERAnti-Diabetics
Metformin, insulin or other anti-diabetic treatments
OTHERActive treatment and monitoring
Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ability to understand and the willingness to sign a written informed consent document. * Age ≥ 18 years and ≤ 80 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. * History of diabetes mellitus, or newly diagnosed diabetes meeting the diagnostic criteria of the American Diabetes Association. * The expected survival ≥ 3 months. * Able to comply with study visit schedules and other protocol requirements.
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.); * Non-primary pancreatic cancer patients; * Digestive tract inflammation, including biliary tract infection, gastrointestinal infection, pancreatitis, etc.; * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS): | 2 months | Time from randomization to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 2 months | Time from enrollment to first tumor progression. |
| Blood Glucose Control | One month | Changes in fasting blood glucose levels. |
| Rate of HbA1c Control | One month | Changes in glycated hemoglobin compared to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Tumor Marker Changes: | One month | Changes in CA19-9, CEA, and CA125 levels compared to baseline |
Countries
China
Contacts
Primary ContactHuanyu Xia, MD
Outcome results
None listed