IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy

December 14, 2025 updated by: Zhongmin Wang, Ruijin Hospital

A Single-Arm, Open-Label Clinical Study of Irreversible Electroporation(IRE) Combined With the Dual-Function Antibody PD-1/CTLA-4 (Apalulizumab) for the Treatment of Locally Advanced Pancreatic Cancer Following Failure of First-Line AG Therapy

The study explores the efficacy and safety of irreversible electroporation(IRE) combined with the dual-function antibody PD-1/CTLA-4 (Apalulizumab) for the treatment of locally advanced pancreatic cancer following failure of first-line AG therapy. This research aims to accumulate more clinical evidence and treatment options for second-line therapy in locally advanced pancreatic cancer following failure of first-line regimen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 2000010
        • Recruiting
        • Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years and above, with no gender restrictions;
  • Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records indicating locally advanced pancreatic cancer;
  • Clinical records indicating previous failure of standard AG treatment (having received at least one cycle of standardized chemotherapy, with disease progression or intolerance during treatment, or disease progression after the end of treatment);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;

  • Adequate organ function, meeting the following criteria:

    a. Hematological tests:

    1. Neutrophils ≥ 1.5 × 10⁹ /L;
    2. White blood cells ≥ 3.0 × 10⁹ /L;
    3. Platelets ≥ 85 × 10⁹ /L;
    4. Hemoglobin ≥ 70 g/L; b. Biochemical tests:
    1. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
    3. Albumin level ≥ 28 g/L;
    4. Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:
    1. Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
    2. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;
  • At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized;
  • Willing to participate and sign the informed consent form;
  • Good compliance and agreement to cooperate with survival follow-up.

Exclusion Criteria:

  • Metastatic pancreatic cancer or has previously undergone interventional treatment for pancreatic cancer;
  • Subjects with ascites requiring clinical intervention (including moderate to large amounts of ascites; subjects with ascites need to be stable for more than 4 weeks after drainage);
  • Clinically severe gastrointestinal diseases (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);
  • NRS pain score ≥ 4 after standardized treatment with analgesics;
  • Second primary malignancy within 5 years (except cured carcinoma in situ, basal cell, or squamous cell skin cancer; subjects with other previous tumors can be enrolled if there has been no recurrence within 5 years);
  • Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg despite optimal treatment);
  • Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml);
  • Active infection or unexplained fever > 38.5°C during the screening period or on the day of administration (subjects with fever caused by tumors can be enrolled as judged by the investigator), which, in the investigator's judgment, would affect the subject's participation in this trial or interfere with the evaluation of efficacy;
  • Known allergy to any components of irinotecan hydrochloride liposome, other liposomes, oxaliplatin, 5-FU, LV, or S-1;
  • Pregnant or breastfeeding women;
  • Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female subjects should use reliable contraception during the trial and for 3 months after the last dose to prevent pregnancy);
  • Subjects with other medical or social issues that, in the investigator's judgment, might affect their ability to sign informed consent, participation in the trial, or interpretation of the trial results;
  • Patients with an estimated survival time of ≤ 3 months are not included in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IRE Combined with the Dual-Function Antibody PD-1/CTLA-4
Drug: Dual-Function Antibody PD-1/CTLA-4
Dual-Function Antibody PD-1/CTLA-4 iv. injection
Radiation: Irreversible electroporation
Irreversible electroporation for pancreatic tumor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival
Time Frame: From enrollment to the death from any cause, assessed up to 18 months
From enrollment to the death from any cause, assessed up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Progression Free Survival
Time Frame: From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months
From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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