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NCT06938503Not yet recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (estimated)
First submitted
14 Apr 2025
Start date
21 Apr 2025
Primary completion date
25 Apr 2028
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
NCT number
NCT06938503

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 48
  • From 21 Apr 2025 to the primary completion date, 25 Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Refuse chemotherapy or surgery;
  • 5\. Undergone major surgery within 30 days;
  • 6\. Participated in other drug related clinical trials within 4 weeks;
  • 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);

Other illness

  • 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;
  • 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);

Other

  • 2\. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
  • 10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.