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A prospective, single-arm, exploratory phase II clinical study evaluating the efficacy of Gemcitabine and Nab-palitaxe combined with Cadonilimab sequential short-course radiotherapy in the treatment of patients with locally advanced pancreatic ductal adenocarcinoma.
Full description
This trial is a prospective, single-arm, single-center, phase II clinical study aimed at investigating the efficacy and safety of Cadonilimab combined with Gemcitabine and Nab-palitaxe in short-course radiotherapy neoadjuvant treatment for locally advanced pancreatic ductal adenocarcinoma patients. Patients will receive Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment for one cycle, followed by sequential short-course radiotherapy and then Gemcitabine and Nab-palitaxe combined with Cadonilimab treatment. If feasible, radical surgery will be performed to assess efficacy. A total of 8 cycles of chemotherapy will be administered, followed by Cadonilimab maintenance for up to 1 year.
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Inclusion criteria
Patients eligible for this study must meet all of the following criteria:
1)Absolute neutrophil count (ANC) ≥1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days.
2)Platelet count ≥100x10^9/L without blood transfusion in the past 14 days. 3)Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 14 days; 4)Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 5)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; 6)Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60ml/min; 7)Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8)Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be included in the study.
9.For female subjects of childbearing potential, a urine or serum pregnancy test should be performed within 3 days before receiving the first dose of the study drug (Day 1 of Cycle 1) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
10.All subjects, male or female, were required to use contraception with an annual failure rate of less than 1% during the entire treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic drug) if there was a risk of pregnancy.
Exclusion criteria
Note: Subjects with the following criteria can also be included:
14.Pregnant or lactating women; 15.Presence of any severe or uncontrolled systemic diseases, such as:
Primary purpose
Allocation
Interventional model
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30 participants in 1 patient group
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Central trial contact
Rui Liu, MD
Data sourced from clinicaltrials.gov
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