Clinical trial · Interventional
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study
NCT06389760CI-TRIAL-00082097recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX | Drug | — | UNRESOLVED |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab+ mFOLFIRINOX/GX
- description
- Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
- interventionNames
- Drug: Nimotuzumab
- Drug: mFOLFIRINOX
- Drug: GX
Primary outcomes (1)
- measure
- disease-free survival (DFS)
- timeFrame
- Up to 24 months
- description
- The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Secondary outcomes (2)
- measure
- overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.