This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with locally advanced pancreatic cancer who have received three cycles of chemotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open IRE followed by continuation of the original chemotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
IRE
continue the original treatment regimen alone
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall Survival (OS)
Time from first antitumor treatment to death from any cause
Time frame: Up to 48 months
Progression-Free Survival (PFS)
Time from randomization to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Time frame: Up to 48 months
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Time frame: Every 2 months up to 18 months
Objective Response Rate (ORR)
Proportion of participants achieving CR or PR per RECIST 1.1.
Time frame: Every 2 months up to 18 months
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