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

NCT07306273 | Recruiting Phase 2

• 1 other identifier: 2025-608
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma Locally Advanced

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From enrollment to the death from any cause, assessed up to 18 months

Secondary Outcomes (1)

• Progression Free Survival

  From enrollment to tumor progression or date of death from any cause, whichever came first, assessed up to 18 months

Study Arms (1)

IRE Combined with the Dual-Function Antibody PD-1/CTLA-4

EXPERIMENTAL

Radiation: Irreversible electroporation; Drug: Dual-Function Antibody PD-1/CTLA-4

Interventions

Irreversible electroporation RADIATION

Irreversible electroporation for pancreatic tumor

IRE Combined with the Dual-Function Antibody PD-1/CTLA-4

Dual-Function Antibody PD-1/CTLA-4 DRUG

Dual-Function Antibody PD-1/CTLA-4 iv. injection

IRE Combined with the Dual-Function Antibody PD-1/CTLA-4

Eligibility Criteria

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

You may qualify if:

• 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:
• Neutrophils ≥ 1.5 × 10⁹ /L;
• White blood cells ≥ 3.0 × 10⁹ /L;
• Platelets ≥ 85 × 10⁹ /L;
• Hemoglobin ≥ 70 g/L; b. Biochemical tests:
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• Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
• Albumin level ≥ 28 g/L;
• Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:

You may not qualify if:

• 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 \&gt; 150 mmHg and/or diastolic blood pressure \&gt; 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 \&gt; 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\&#39;s judgment, would affect the subject\&#39;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\&#39;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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 2000010, China

RECRUITING

MeSH Terms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Zhongmin Wang, Doctor

CONTACT

0086-13901848333; wzm11896@rjh.com.cn

Jingfeng Li, Doctor

CONTACT

0086-13918536451; 13918536451@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)