Pancreatic Cancer
Conditions
Keywords
Nimotuzumab, mFOLFIRINOX, adjuvant therapy, pancreatic cancer, GX
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.
Interventions
DRUGNimotuzumab
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).
DRUGmFOLFIRINOX
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).
DRUGGX
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).
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | Up to 24 months | The time from the date of surgery to the disease recurrence or death, whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | Up to 24 months | The time from the date of surgery to death due to any cause. |
| adverse events | Up to 30 days after last administration | Frequency and severity of adverse events. |
Countries
China
Contacts
Primary ContactJuan Du, MD
Outcome results
None listed