Pancreatic CancerNCT06677762
Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Irreversible electroporation
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Study on the Efficacy of 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Irreversible electroporation
- Keywords
- Pancreatic cancer, irreversible electroporation, PD-(L)1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporationProcedure or surgery
Irreversible electroporation ablation is an interventional ablation method, while anti-PD(L)1 is an immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| IRE group | Patients who receive IRE ablation only Receives: Procedure: Irreversible electroporation | |
| IRE+anti-PD（L）1 | Patients who receive IRE ablation combined with anti-PD（L）1 Receives: Procedure: Irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS，Overall Survival
The patient received treatment until death.
Measured: 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
Measured: 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
The proportion of patients whose tumor size decreases to a predetermined value and can maintain that minimum value for the required duration.
Measured: From the time of treatment to tumor response or date of death from any cause, whichevercame first, assessed up to 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677762
- Sponsor's protocol ID
- 2024-421
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Efficacy of Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06677762
- Acronym / sponsor ID
- 2024-421
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, irreversible electroporation, PD-(L)1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE group | – | Procedure: Irreversible electroporationPatients who receive IRE ablation only |
| IRE+anti-PD（L）1 | – | Procedure: Irreversible electroporationPatients who receive IRE ablation combined with anti-PD（L）1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible electroporationIrreversible electroporation ablation is an interventional ablation method, while anti-PD(L)1 is an immunotherapy. | Procedure or surgery | IRE group, IRE+anti-PD（L）1 |
Primary outcome
OS，Overall Survival
Time frame: From the time of treatment to the death from any cause, assessed up to 35 months
The patient received treatment until death.
PFS，Progress Free Survival
Time frame: From the time of treatment to tumor progression or date of death from any cause, whichever came first, assessed up to 35 months
Time of progression or death of the patient
1 secondary outcome
ORR，Objective response rate
Time frame: From the time of treatment to tumor response or date of death from any cause, whichevercame first, assessed up to 35 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongmin Wang Wang (13901848333, wzm11896@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS，Overall Survival (time frame: From the time of treatment to the death from any cause, assessed up to 35 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.