Pancreatic CancerPhase 3PTCA199-16NCT07272109
Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes
A Phase 3 study testing Nab-paclitaxel, Gemcitabine (1000 mg/m2) and Anti-Diabetics in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Nab-paclitaxel, Gemcitabine (1000 mg/m2) and Anti-Diabetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Cancer Center
Shanghai, 200032
Guopei Luo, +86868621641755, luoguopei@hotmail.com
About this study
Official title: Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)
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.
Read the detailed 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Nab-paclitaxel, Gemcitabine (1000 mg/m2), Anti-Diabetics, Active treatment and monitoring
- Keywords
- diabetes melltus, metastatic pancreatic cancer, type 3c
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Active treatment and monitoringOther
Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.
| Study group | Role | What they receive |
|---|---|---|
| Active anti-diabetic treatment | Experimental | Not described Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine (1000 mg/m2); Other: Anti-Diabetics; Other: Active treatment and monitoring |
| Regular anti-diabetic treatment | Active comparator | Not described Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine (1000 mg/m2); Other: Anti-Diabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS):
Time from randomization to death from any cause
Measured: 2 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
Time from enrollment to first tumor progression.
Measured: 2 months
Blood Glucose Control
Changes in fasting blood glucose levels.
Measured: One month
Rate of HbA1c Control
Changes in glycated hemoglobin compared to baseline.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Luo, Fudan University
- Investigators
- Guopei Luo, MD, Study chair, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272109
- Sponsor's protocol ID
- PTCA199-16
- Acronym
- PTCA199-16
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38050737
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)
- ClinicalTrials.gov ID
- NCT07272109
- Acronym / sponsor ID
- PTCA199-16 / PTCA199-16
- Conditions
- Pancreatic Cancer
- Keywords
- diabetes melltus, metastatic pancreatic cancer, type 3c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active anti-diabetic treatment | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine (1000 mg/m2), Other: Anti-Diabetics, Other: Active treatment and monitoring |
| Regular anti-diabetic treatment | Active comparator | Drug: Nab-paclitaxel, Drug: Gemcitabine (1000 mg/m2), Other: Anti-Diabetics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- • 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxel120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks | Drug | Active anti-diabetic treatment, Regular anti-diabetic treatment |
| Gemcitabine (1000 mg/m2)(1000 mg per square meter) on days 1, 8, and 15 every 4 weeks | Drug | Active anti-diabetic treatment, Regular anti-diabetic treatment |
| Anti-DiabeticsMetformin, insulin or other anti-diabetic treatments | Other | Active anti-diabetic treatment, Regular anti-diabetic treatment |
| Active treatment and monitoringAttend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation. | Other | Active anti-diabetic treatment |
Primary outcome
Overall Survival (OS):
Time frame: 2 months
Time from randomization to death from any cause
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 months
Blood Glucose Control
Time frame: One month
Rate of HbA1c Control
Time frame: One month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 38050737Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guopei Luo, MD study chair
Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nab-paclitaxel, Gemcitabine (1000 mg/m2) and Anti-Diabetics in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanyu Xia, MD (+86868621641755, luoguopei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS): (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.