NCT07272109

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3 pancreatic-cancer

Timeline
32mo left

Started Jan 2026

Shorter than P25 for phase_3 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 26, 2025

Last Update Submit

December 8, 2025

Conditions

Pancreatic Cancer

Keywords

diabetes melltusmetastatic pancreatic cancertype 3c

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS):

    Time from randomization to death from any cause

    2 months

Secondary Outcomes (3)

  • Progression-Free Survival (PFS)

    2 months

  • Blood Glucose Control

    One month

  • Rate of HbA1c Control

    One month

Other Outcomes (1)

  • Serum Tumor Marker Changes:

    One month

Study Arms (2)

Active anti-diabetic treatment

EXPERIMENTAL
Drug: Nab-paclitaxelDrug: Gemcitabine (1000 mg/m2)Other: Anti-DiabeticsOther: Active treatment and monitoring

Regular anti-diabetic treatment

ACTIVE COMPARATOR
Drug: Nab-paclitaxelDrug: Gemcitabine (1000 mg/m2)Other: Anti-Diabetics

Interventions

Active treatment and monitoringOTHER

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

Active anti-diabetic treatment
Nab-paclitaxelDRUG

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

Active anti-diabetic treatmentRegular anti-diabetic treatment
Gemcitabine (1000 mg/m2)DRUG

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

Active anti-diabetic treatmentRegular anti-diabetic treatment
Anti-DiabeticsOTHER

Metformin, insulin or other anti-diabetic treatments

Active anti-diabetic treatmentRegular anti-diabetic treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

  • 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: 38050737RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxelGemcitabineHypoglycemic Agents

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Guopei Luo, MD

    Shanghai Cancer Center

    STUDY CHAIR

Central Study Contacts

Huanyu Xia, MD

CONTACT

+86868621641755luoguopei@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

December 15, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)