Clinical trial NCT06389760: Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Official title: Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Nimotuzumab
mFOLFIRINOX
adjuvant therapy
pancreatic cancer
GX
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: Up to 24 months
measure: adverse events
timeFrame: Up to 30 days after last administration
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Juan Du, MD
role: STUDY_CHAIR
References: