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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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).
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).
overall survival (OS)
OS, defined as the time from the beginning of treatment to death due to any cause.
Time frame: Up to 24 months
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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 24 months
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