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2024-11-10
2025-06-30
2025-06-30
55
NCT06677762
Ruijin Hospital
Ruijin Hospital
OBSERVATIONAL
Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-10-30 | N/A | 2024-11-04 |
2024-11-04 | N/A | 2024-11-07 |
2024-11-07 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | From the time of treatment to tumor response or date of death from any cause, whichevercame first, assessed up to 35 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zhongmin Wang Wang Phone Number: 13901848333 Email: wzm11896@rjh.com.cn |
Study Contact Backup Name: Xiaoyu Liu Liu Phone Number: 15121013042 Email: lxy12931@rjh.com.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
