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

NCT ID: NCT06677762

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-06-30

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

IRE group

Patients who receive IRE ablation only

Irreversible electroporation

Intervention Type: PROCEDURE

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

IRE+anti-PD（L）1

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

Irreversible electroporation

Intervention Type: PROCEDURE

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

Interventions

Irreversible electroporation

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhongmin Wang Wang

Role: CONTACT

wzm11896@rjh.com.cn

13901848333

Xiaoyu Liu Liu

Role: CONTACT

lxy12931@rjh.com.cn

15121013042

Other Identifiers

2024-421

Identifier Type: -

Identifier Source: org_study_id