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

Study Overview

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

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. The main endpoint is overall survival (OS).

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.

Pancreatic Cancer, Adult

DRUG: AG regimen
DRUG: Nimotuzumab

IST-PC-202501

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-14
First Submitted that Met QC Criteria 2025-04-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-22
First Posted (ACTUAL) 2025-04-22	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: AG+Nimotuzumab	DRUG: AG regimen 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 m DRUG: Nimotuzumab 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: AG+Nimotuzumab

DRUG: AG regimen

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 m

DRUG: Nimotuzumab

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).

Primary Outcome Measures	Measure Description	Time Frame
overall survival (OS)	OS, defined as the time from the beginning of treatment to death due to any cause.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
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.	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.	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).	Up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;
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.

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;
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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