Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 4:52 AM
Study NCT ID:
NCT06938503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
A Prospective, Single-Arm Study of Nab-paclitaxel/Gemcitabine Combined With Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: