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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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

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‣ Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;

⁃ 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.

Locations
Other Locations
China
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Zhongmin Wang, Doctor
wzm11896@rjh.com.cn
0086-13901848333
Backup
Jingfeng Li, Doctor
13918536451@163.com
0086-13918536451
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 20
Treatments
Experimental: IRE Combined with the Dual-Function Antibody PD-1/CTLA-4
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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