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

Phase 2

Not yet recruiting

• Conditions: Pancreatic Cancer, Adult
• Interventions: Drug: AG regimen; Drug: Nimotuzumab

• Registration Number: NCT06938503
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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. The main endpoint is overall survival (OS).

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study Start: 2025-04-21
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-04-25
• Study Completion: 2028-04-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AG+Nimotuzumab	AG regimen	-
AG+Nimotuzumab	Nimotuzumab	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	Up to 24 months	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.
Objective response rate (ORR)	Up to 24 months	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.
Disease control rate (DCR)	Up to 24 months	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).