Clinical trial NCT06677762: Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer
Official title: A Retrospective Study on the Efficacy of Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
irreversible electroporation
PD-(L)1
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: OS，Overall Survival
timeFrame: From the time of treatment to the death from any cause, assessed up to 35 months
measure: PFS，Progress Free Survival
timeFrame: 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:
measure: ORR，Objective response rate
timeFrame: From the time of treatment to tumor response or date of death from any cause, whichevercame first, assessed up to 35 months
Other outcomes:
Locations:
Study officials:
References: