About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, any sex.
Disqualifiers
Refusal to receive systemic chemotherapy or possible surgery.
Trial design
Parallel
Treatments tested in this trial
IRE
Other interventionIRE
PLACEBO
Other interventioncontinue the original treatment regimen alone
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival (OS)
Time from first antitumor treatment to death from any cause
Progression-Free Survival (PFS)
Time from randomization to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Secondary outcomes
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Objective Response Rate (ORR)
Proportion of participants achieving CR or PR per RECIST 1.1.
Sponsors and contacts
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