Overview
This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.
Description
This clinical study is designed as a prospective, multicenter, single arm, open-label study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included overall survival (OS) and safety.
Eligibility
Inclusion Criteria:
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- Age 18 years or older, gender unlimited;
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2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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3. Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1
resection) with histological confirmation and with no evidence of distant
metastasis as demonstrated by imaging;
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4. No prior tumor therapy;
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5. Adequate organ and bone marrow function, defined as follows: White blood cells
(WBC) ≥ 3.0×10^9/L; absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin≥9.0
g/dL; platelets≥75×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper
limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance
≥ 50 mL/min;
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6. Left ventricular ejection fraction (LVEF) ≥ 50%;
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7. Fertile subjects are willing to take contraceptive measures during the study
period.
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8. good compliance and signed informed consent voluntarily
Exclusion Criteria:
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- Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
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2. Participated in other drug clinical trials within 4 weeks;
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3. History of other malignancies;
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4. Immunodeficiency, or other immune-related disorders requiring medical
intervention;
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5. Postoperative complications such as bleeding;
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6. Woman who are pregnant or breastfeeding;
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7. Drug abuse, or clinical, psychological or social factors that may have an
impact on informed consent or the implementation of the study;
- 8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.