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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active anti-diabetic treatment

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

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

Gemcitabine (1000 mg/m2)

Intervention Type DRUG

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

Anti-Diabetics

Intervention Type OTHER

Metformin, insulin or other anti-diabetic treatments

Active treatment and monitoring

Intervention Type OTHER

Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.

Regular anti-diabetic treatment

Group Type ACTIVE_COMPARATOR

Nab-paclitaxel

Intervention Type DRUG

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

Gemcitabine (1000 mg/m2)

Intervention Type DRUG

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

Anti-Diabetics

Intervention Type OTHER

Metformin, insulin or other anti-diabetic treatments

Interventions

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Nab-paclitaxel

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

Intervention Type DRUG

Gemcitabine (1000 mg/m2)

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

Intervention Type DRUG

Anti-Diabetics

Metformin, insulin or other anti-diabetic treatments

Intervention Type OTHER

Active treatment and monitoring

Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No