Pancreatic Cancer, AdultPhase 2NCT06938503

AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer

A Phase 2 study testing AG regimen and Nimotuzumab in people with Pancreatic Cancer, Adult, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

This is a prospective, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of nab-paclitaxel/gemcitabine combined with nimotuzumab sequential irreversible electroporation ablation for locally advanced pancreatic cancer. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Cancer, Adult
What is being tested?: AG regimen and Nimotuzumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 21 Apr 2025to 28 Apr 2028
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed pancreatic cancer;
3. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
4. No prior chemotherapy or other tumor systemic therapy;
5. Measurable disease according to RECIST criteria v1.1;
6. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance > 60 mL/min;

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7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
8. Life expectancy is expected to be ≥3 months;
9. Fertile subjects are willing to take contraceptive measures during the study period.
10. Good compliance and signed informed consent voluntarily.

Who cannot join

1. Refuse chemotherapy or surgery;
2. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
4. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
5. Undergone major surgery within 30 days;
6. Participated in other drug related clinical trials within 4 weeks;

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7. Known allergy to prescription or any component of the prescription used in this study;
8. With HIV, or active hepatitis (hepatitis B, hepatitis C);
9. Failure to recover from treatment-related toxicity to ≤ grade 1 (adverse events such as alopecia judged by the researcher not to affect the treatment with the research drug are excluded);
10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

About this study

Official title: A Prospective, Single-Arm Study of Nab-paclitaxel/Gemcitabine Combined With Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer

Read the detailed description

This clinical study is designed as a prospective, open-label, single arm study to evaluate the clinical efficacy and safety of nab-paclitaxel/gemcitabine combined with nimotuzumab sequential irreversible electroporation ablation for locally advanced pancreatic cancer. This study is divided into two stages: in stage I, all patients will receive 4 cycles of nab-paclitaxel/gemcitabine (AG regimen, 3 weeks as a cycle) and nimotuzumab. Imaging reexamination will be conducted 12 weeks later. In stage II, patients who are without disease progression (PD) will receive irreversible electroporation ablation and at least 3 cycles of adjuvant treatment (AG and nimotuzumab). If the imaging evaluation shows disease progression (PD), then the subsequent treatment will be changed to the standard treatment in hospital. The main endpoint is overall survival (OS). Additional end points included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety, etc.

Conditions: Pancreatic Cancer, Adult
Being tested: AG regimen, Nimotuzumab
Medical subject headings: Pancreatic cancer, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AG regimenDrug
Patients will receive 4 cycles of AG (gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2 on days 1 and 8 of a 21-day cycle), followed by Irreversible Electroporation Ablation and 3 cycles of adjuvant AG (gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2 on days 1 and 8 of a 21-day cycle).
NimotuzumabDrug
Patients will receive 4 cycles of Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by Irreversible Electroporation Ablation and 3 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).

Study groups in NCT06938503
Study group	Role	What they receive
AG+Nimotuzumab	Experimental	Not described Receives: Drug: AG regimen; Drug: Nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

overall survival (OS)
OS, defined as the time from the beginning of treatment to death due to any cause.
Measured: Up to 24 months

Secondary outcomes (3)

progression-free survival (PFS)
PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 24 months
Objective response rate (ORR)
Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
Measured: Up to 24 months
Disease control rate (DCR)
Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202528 Apr 2028

First posted22 Apr 2025
Study start21 Apr 2025 (estimated)
Primary completion25 Apr 2028 (estimated)
Study completion28 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06938503
Sponsor's protocol ID: IST-PC-202501
Status last verified: Apr 2025
First submitted: 14 Apr 2025
Last updated: 22 Apr 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor

All Pancreatic Cancer, Adult trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm Study of Nab-paclitaxel/Gemcitabine Combined With Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06938503
Acronym / sponsor ID: IST-PC-202501
Conditions: Pancreatic Cancer, Adult
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: 21 Apr 2025 (estimated)
Primary completion: 25 Apr 2028 (estimated)
Study completion: 28 Apr 2028 (estimated)
First posted: 22 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AG+Nimotuzumab	Experimental	Drug: AG regimen, Drug: Nimotuzumab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed pancreatic cancer;
3. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
4. No prior chemotherapy or other tumor systemic therapy;
5. Measurable disease according to RECIST criteria v1.1;

Key exclusion criteria (10 listed)

1. Refuse chemotherapy or surgery;
2. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
4. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
5. Undergone major surgery within 30 days;

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
AG regimenPatients will receive 4 cycles of AG (gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2 on days 1 and 8 of a 21-day cycle), followed by Irreversible Electroporation Ablation and 3 cycles of adjuvant AG (gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2 on days 1 and 8 of a 21-day cycle).	Drug	AG+Nimotuzumab
NimotuzumabPatients will receive 4 cycles of Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by Irreversible Electroporation Ablation and 3 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).	Drug	AG+Nimotuzumab

Primary outcome

overall survival (OS)
Time frame: Up to 24 months
OS, defined as the time from the beginning of treatment to death due to any cause.

3 secondary outcomes

progression-free survival (PFS)
Time frame: Up to 24 months
Objective response rate (ORR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months

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 22 Apr 2025.

Related trials for Pancreatic Cancer, Adult

RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
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RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
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Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AG regimen and Nimotuzumab in people with Pancreatic Cancer, Adult, run by Tianjin Medical University Cancer Institute and Hospital.

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 10 inclusion and 10 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 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (OS) (time frame: Up to 24 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 NCT06938503.

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 22 Apr 2025.