CClinicalTrials.gg
Not yet recruitingNCT06677762Updated Nov 7, 2024

Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer

An observational study in Pancreatic Cancer, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study summary

Pancreatic cancer is a highly lethal malignant tumor of the digestive tract, especially local advanced pancreatic cancer (LAPC), which often loses the opportunity for surgical resection at the time of diagnosis. LAPC patients are often accompanied by tumor invasion of key anatomical structures such as major blood vessels, and traditional treatment methods such as radiotherapy and chemotherapy can slow down the progression of the disease, but the effect is limited, and the overall survival rate is still very low. There is a lack of effective treatment options for LAPC, especially in local control and prolonging survival, which exists a major limitation.

The surgical resection rate is low in LAPC, and the postoperative recurrence rate is high, and traditional radiotherapy and chemotherapy are difficult to completely eliminate the tumor. Immunotherapy has achieved breakthroughs in other tumors such as melanoma and non-small cell lung cancer, but the effect is limited in pancreatic cancer due to the immunosuppressive state of the tumor microenvironment (TME), which limits the efficacy of immunotherapy. In addition, the high invasiveness and rapid progression of pancreatic cancer further aggravates the treatment challenge.

Recent studies have shown that local ablation techniques such as irreversible electroporation (IRE) ablation not only can effectively ablate local tumors, but also may destroy the structural integrity of tumor cells, release tumor-associated antigens, and enhance the anti-tumor effect of the immune system. Therefore, IRE ablation may provide local control of pancreatic cancer for patients. At the same time, the combination of immune checkpoint inhibitors such as anti-PD(L)1 inhibitors may enhance the immune response in the tumor microenvironment and further improve the therapeutic effect. This combined treatment regimen is expected to overcome the limitations of single therapy and provide a new treatment strategy for local advanced pancreatic cancer.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Pancreatic cancer
  • irreversible electroporation
  • PD-(L)1
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 55 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Include patients with locally advanced pancreatic cancer who received IRE ablation and combined anti-PD(L)1 treatment at Ruijin Hospital from January 2017 to December 2023.

Inclusion criteria

  • The pathological diagnosis is local advanced pancreatic cancer that cannot be removed by surgery;
  • Received IRE ablation treatment alone or in combination with anti-PD-1 or anti-PD-L1 immune inhibitors;
  • Aged 18 years or older, gender is not limited, ECOG score 0-2;
  • Have complete medical records and imaging follow-up records;
  • At least 6 months of follow-up data.

Exclusion criteria

Exclusion Criteria:

  • Patients with other malignant tumors or severe immune system disorders;
  • Patients who cannot complete follow-up or have missing data;
  • Patients who have previously received immunotherapy without effect;
  • Patients with severe organ dysfunction or who cannot tolerate further - - treatment.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
55 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • IRE group

    Patients who receive IRE ablation only

    Procedure: Irreversible electroporation

  • IRE+anti-PD(L)1

    Patients who receive IRE ablation combined with anti-PD(L)1

    Procedure: Irreversible electroporation

Interventions

  • ProcedureIrreversible electroporation

    Irreversible electroporation ablation is an interventional ablation method, while anti-PD(L)1 is an immunotherapy.

06

What researchers measure

Primary outcomes

  1. OS,Overall Survival

    The patient received treatment until death.

    Time frame: From the time of treatment to the death from any cause, assessed up to 35 months

  2. PFS,Progress Free Survival

    Time of progression or death of the patient

    Time frame: From the time of treatment to tumor progression or date of death from any cause, whichever came first, assessed up to 35 months

Secondary outcomes

  1. ORR,Objective response rate

    The proportion of patients whose tumor size decreases to a predetermined value and can maintain that minimum value for the required duration.

    Time frame: From the time of treatment to tumor response or date of death from any cause, whichevercame first, assessed up to 35 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06677762
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Nov 7, 2024
Start date
Nov 10, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Nov 7, 2024

Study contacts

Zhongmin Wang Wang
Contact
wzm11896@rjh.com.cn
13901848333
Xiaoyu Liu Liu
Contact
lxy12931@rjh.com.cn
15121013042

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion