NCT07306286 Cryoablation Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Therapy
| NCT ID | NCT07306286 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Pancreatic Adenocarcinoma Locally Advanced |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-08-01 |
Trial Parameters
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Brief Summary
The study explores the efficacy and safety of cryoablation 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 Criteria
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 (