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

Официальное название

Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Nimotuzumab
  When combined with the mFOLFIRINOX regimen, nimotuzumab (nimo) will be administered at a dose of 400mg on Day 1 and 15 of a 28-day cycle (6 cycles). When combined with the GX regimen, nimotuzumab will be given at 400mg on Day 1 and 8 of a 21-day cycle (8 cycles).
• Препарат mFOLFIRINOX
  Patients will receive mFOLFIRINOX as follows: Oxaliplatin 65 mg/m2 on Day 1 and 15 of a 28-day cycle; Irinotecan 130 mg/m2 on Day 1 and 15 of a 28-day cycle; Leucovorin(LV) 200 mg/m2 Day 1 and 15 of a 28-day cycle; 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day 1 and 15 of a 28-day cycle (6 cycles).
• Препарат GX
  Patients will receive GX regimen as follows: Gemcitabine 1000 mg/m2 on Day 1 and 8 of a 21-day cycle; capecitabine 2000 mg/m2 on d1-14 a 21-day cycle(8 cycles).

Первичные конечные точки

• disease-free survival (DFS) [Срок оценки: Up to 24 months]

Вторичные конечные точки (2)

• overall survival (OS) [Срок оценки: Up to 24 months]
• adverse events [Срок оценки: Up to 30 days after last administration]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Нанкин

Идентификаторы

NCT: NCT06389760 · IST-Nim-PC-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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