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

NCT06677762 | Not Yet Recruiting DMC

• 1 other identifier: 2024-421
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pancreatic cancer; irreversible electroporation; PD-(L)1

Outcome Measures

Primary Outcomes (2)

• OS，Overall Survival

  The patient received treatment until death.

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

• PFS，Progress Free Survival

  Time of progression or death of the patient

  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

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

Study Arms (2)

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

Irreversible electroporation PROCEDURE

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

IRE group; IRE+anti-PD（L）1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Preserve the tissue and paraffin from pancreatic cancer and liver metastasis.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Zhongmin Wang Wang

CONTACT

13901848333; wzm11896@rjh.com.cn

Xiaoyu Liu Liu

CONTACT

15121013042; lxy12931@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 7, 2024
• Study Start: November 10, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share