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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Pancreatic Cancer

Treatments

Procedure: Irreversible electroporation

Study type

Observational

Funder types

Other

Identifiers

NCT06677762
2024-421

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

55 participants in 2 patient groups

IRE group
Description:
Patients who receive IRE ablation only
Treatment:
Procedure: Irreversible electroporation
IRE+anti-PD(L)1
Description:
Patients who receive IRE ablation combined with anti-PD(L)1
Treatment:
Procedure: Irreversible electroporation

Trial contacts and locations

0

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Central trial contact

Zhongmin Wang Wang; Xiaoyu Liu Liu

Data sourced from clinicaltrials.gov

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