Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes

Официальное название

Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Nab-paclitaxel
  120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks
• Препарат Gemcitabine (1000 mg/m2)
  (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
• Другое Anti-Diabetics
  Metformin, insulin or other anti-diabetic treatments
• Другое Active treatment and monitoring
  Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.

Первичные конечные точки

• Overall Survival (OS): [Срок оценки: 2 months]

Вторичные конечные точки (3)

• Progression-Free Survival (PFS) [Срок оценки: 2 months]
• Blood Glucose Control [Срок оценки: One month]
• Rate of HbA1c Control [Срок оценки: One month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Cancer Center — Шанхай

Публикации

• 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. PMID 38050737

Идентификаторы

NCT: NCT07272109 · PTCA199-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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