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NCT Number: NCT07272109

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nab-paclitaxel

Drug

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-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.

Primary outcomes

  1. Overall Survival (OS):

    Time frame: 2 months

    Time from randomization to death from any cause

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 2 months

    Time from enrollment to first tumor progression.

  2. Blood Glucose Control

    Time frame: One month

    Changes in fasting blood glucose levels.

  3. Rate of HbA1c Control

    Time frame: One month

    Changes in glycated hemoglobin compared to baseline.

Other outcomes

  1. Serum Tumor Marker Changes:

    Time frame: One month

    Changes in CA19-9, CEA, and CA125 levels compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Huanyu Xia, MD

CONTACT

[email protected]

+86868621641755

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: PTCA199-16

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 9, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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