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

Phase 3Not Yet RecruitingNCT07272109

Fudan University210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Pancreatic Cancer

Interventions

Nab-paclitaxelDRUG

120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks

Gemcitabine (1000 mg/m2)DRUG

(1000 mg per square meter) on days 1, 8, and 15 every 4 weeks

Anti-DiabeticsOTHER

Metformin, insulin or other anti-diabetic treatments

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

Overall Survival (OS):

Time from randomization to death from any cause

Time frame: 2 months

Secondary Outcomes

Progression-Free Survival (PFS)

Time from enrollment to first tumor progression.

Time frame: 2 months

Blood Glucose Control

Changes in fasting blood glucose levels.

Time frame: One month

Rate of HbA1c Control

Changes in glycated hemoglobin compared to baseline.

Time frame: One month

Central Contacts

Huanyu Xia, MD

CONTACT

+86868621641755 luoguopei@hotmail.com

Data from ClinicalTrials.gov

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