Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes (PTCA199-16)

Fudan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: Nab-paclitaxel; Drug: Gemcitabine (1000 mg/m2); Other: Anti-Diabetics; Other: Active treatment and monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07272109

PTCA199-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Active anti-diabetic treatment

Experimental group

Treatment:

Other: Active treatment and monitoring

Other: Anti-Diabetics

Drug: Gemcitabine (1000 mg/m2)

Drug: Nab-paclitaxel

Regular anti-diabetic treatment

Active Comparator group

Treatment:

Other: Anti-Diabetics

Drug: Gemcitabine (1000 mg/m2)

Drug: Nab-paclitaxel