IRE After Chemotherapy for Locally Advanced Pancreatic Cancer

ConditionIRE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

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 volunteers

Qualifiers

Age 18-75 years, any sex.

Disqualifiers

Refusal to receive systemic chemotherapy or possible surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IRE

    Other intervention

    IRE

  • PLACEBO

    Other intervention

    continue the original treatment regimen alone

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: IRE + chemotherapy continuationExperimental treatment 1 intervention
Group B: chemotherapy continuation alonePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time from first antitumor treatment to death from any cause

Time frame
Up to 48 months
2

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

Secondary outcomes

1

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
2

Objective Response Rate (ORR)

Proportion of participants achieving CR or PR per RECIST 1.1.

Time frame
Every 2 months up to 18 months

Other outcomes

Sponsors and contacts

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