Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Summary

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.

Eligibility

Inclusion Criteria:

* 1\. Age 18 years or older, gender unlimited;
* 2\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* 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;
* 4\. No prior tumor therapy;
* 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;
* 6\. Left ventricular ejection fraction (LVEF) ≥ 50%;
* 7\. Fertile subjects are willing to take contraceptive measures during the study period.
* 8\. good compliance and signed informed consent voluntarily

Exclusion Criteria:

* 1\. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
* 2\. Participated in other drug clinical trials within 4 weeks;
* 3\. History of other malignancies;
* 4\. Immunodeficiency, or other immune-related disorders requiring medical intervention;
* 5\. Postoperative complications such as bleeding;
* 6\. Woman who are pregnant or breastfeeding;
* 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.

Conditions2

Interventions3

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