Actively Recruiting
IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy
Led by Ruijin Hospital · Updated on 2025-12-29
20
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above, any gender
- Pathologically confirmed pancreatic cancer originating from the pancreatic ductal epithelium with clinical evidence of locally advanced disease
- Documented failure of standard AG chemotherapy treatment, including at least one cycle of chemotherapy with disease progression or intolerance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function including neutrophils 710^9/L 21.5, white blood cells 710^9/L 213.0, platelets 710^9/L 2185, hemoglobin 2170 g/L
- Total bilirubin 2 times upper limit of normal (ULN), or 2.5 times ULN after biliary drainage if biliary obstruction is present
- AST and ALT 25 times ULN in patients with metastases
- Albumin level 28 g/L or higher
- Creatinine clearance rate 260 ml/min or higher
- Normal electrocardiogram or clinically insignificant abnormalities
- Left ventricular ejection fraction at or above the lower limit of normal
- At least 3 weeks since surgery, radiotherapy, chemotherapy, or other anti-tumor treatments with recovery or stabilization of any adverse effects (toxicity 21 grade 1)
- Willingness to participate and provide informed consent
- Good compliance and agreement to cooperate with survival follow-up
You will not qualify if you...
- Presence of metastatic pancreatic cancer or prior interventional treatment for pancreatic cancer
- Ascites requiring clinical intervention or unstable ascites within 4 weeks after drainage
- Severe gastrointestinal diseases such as bleeding, infection, perforation, obstruction, or diarrhea worse than grade 1
- Pain score of 4 or higher after standardized analgesic treatment
- Second primary malignancy within 5 years except cured carcinoma in situ, basal cell, or squamous cell skin cancer
- Uncontrolled cardiovascular or cerebrovascular diseases including NYHA class III or higher heart failure, unstable angina, recent myocardial infarction or stroke within 6 months, arrhythmias needing treatment, or uncontrolled hypertension
- Active hepatitis B infection with high viral load
- Active infection or unexplained fever above 38.5�b0C during screening or administration day (unless tumor-related fever as judged by investigator)
- Known allergy to irinotecan hydrochloride liposome, other liposomes, oxaliplatin, 5-FU, LV, or S-1
- Pregnant or breastfeeding women
- Positive pregnancy test during screening for women of childbearing potential; reliable contraception required for all participants during the trial and for 3 months after last dose
- Other medical or social issues affecting consent, participation, or data interpretation
- Estimated survival time of 3 months or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000010
Actively Recruiting
Research Team
Z
Zhongmin Wang, Doctor
CONTACT
J
Jingfeng Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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