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

NCT06938503 | Not Yet Recruiting Phase 2

• 1 other identifier: IST-PC-202501
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pancreatic Cancer, Adult

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  OS, defined as the time from the beginning of treatment to death due to any cause.

  Up to 24 months

Secondary Outcomes (3)

• progression-free survival (PFS)

  Up to 24 months

• Objective response rate (ORR)

  Up to 24 months

• Disease control rate (DCR)

  Up to 24 months

Study Arms (1)

AG+Nimotuzumab

EXPERIMENTAL

Drug: AG regimen; Drug: Nimotuzumab

Interventions

AG regimen DRUG

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).

AG+Nimotuzumab

Nimotuzumab DRUG

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).

AG+Nimotuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years old, gender unlimited;
• \. Histologically or cytologically confirmed pancreatic cancer;
• \. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
• \. No prior chemotherapy or other tumor systemic therapy;
• \. Measurable disease according to RECIST criteria v1.1;
• \. 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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
• \. Life expectancy is expected to be ≥3 months;
• \. Fertile subjects are willing to take contraceptive measures during the study period.
• \. Good compliance and signed informed consent voluntarily.

You may not qualify if:

• \. Refuse chemotherapy or surgery;
• \. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
• \. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• \. 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;
• \. Undergone major surgery within 30 days;
• \. Participated in other drug related clinical trials within 4 weeks;
• \. Known allergy to prescription or any component of the prescription used in this study;
• \. With HIV, or active hepatitis (hepatitis B, hepatitis C);
• \. 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);
• Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Pancreatic cancer, adult

Interventions

nimotuzumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): April 25, 2028
• Study Completion (Estimated): April 28, 2028
• Last Updated: April 22, 2025

Record last verified: 2025-04