Irreversible electroporation plus a dual PD-1/CTLA-4 antibody for locally advanced pancreatic cancer after first-line AG stops working

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial combines a local ablation technique (irreversible electroporation, IRE) with systemic immunotherapy using a dual-function PD-1/CTLA-4 antibody (apalulizumab) in patients with locally advanced pancreatic adenocarcinoma after failure of first-line AG therapy. Eligible adults must have pathologically confirmed locally advanced disease, prior progression or intolerance on AG (gemcitabine plus nab-paclitaxel), ECOG performance status 0–2, and adequate organ function. The protocol delivers IRE to the pancreatic tumor followed by scheduled infusions of the antibody and monitors patients for safety, tumor response, and clinical outcomes. The goal is to gather clinical evidence about safety and anti-tumor activity to inform second-line treatment options for this patient group.

Why it matters

Who can join: the full rules

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:

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  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:

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  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 \&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.

Where it's running

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

Study contacts

• Study coordinator: Zhongmin Wang, Doctor
• Email: wzm11896@rjh.com.cn
• Phone: 0086-13901848333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cryoablation combined with the dual-function PD-1/CTLA-4 antibody Apalulizumab for locally advanced pancreatic adenocarcinoma after first-line AG failure

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• AB801 with chemotherapy and immunotherapy for cholangiocarcinoma and pancreatic cancer

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• Surgery after tumor-shrinking treatment for locally advanced pancreatic cancer

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• Comparing NALIRIFOX to a modified gemcitabine/nab‑paclitaxel/cisplatin regimen for advanced pancreatic adenocarcinoma

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• Adding panitumumab to chemotherapy for unresectable or metastatic KRAS wild-type pancreatic cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.