Clinical trial · Interventional
Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
A Prospective, Single Arm Study of Nimotuzumab Combined With NALIRIFOX in the Treatment of Locally Advanced Pancreatic Cancer
NCT06429904CI-TRIAL-00077476active not recruitingPhase 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, open-label, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (LAPC).
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 |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab+ NALIRIFOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab combined with NALIRIFOX
- description
- Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer
- interventionNames
- Drug: Nimotuzumab+ NALIRIFOX
Primary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- Up to 24 months
- description
- The time from the beginning of treatment to death due to any cause.
Secondary outcomes (5)
- measure
- resection rate
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, gender unlimited; 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3. Locally advanced pancreatic cancer, no evidence of distant metastasis as demonstrated by imaging; 4. Receive nimotuzumab and NALIRIFOX for voluntary, and patients can tolerate NALIRIFOX by researcher's evaluation; 5. No prior tumor systemic therapy. 6. Measurable disease according to RECIST criteria v1.1; 7. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^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≤1.5×ULN or estimated creatinine clearance \> 60 mL/min; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. Postoperative survival was expected to be ≥3 months; 10. Fertile subjects are willing to take contraceptive measures during the study period. 11. Good compliance and signed informed consent voluntarily. Exclusion Criteria: 1. Refuse chemotherapy or surgery; 2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency; 4. Undergone major surgery within 30 days; 5. Use of EGFR-mab or EGFR-TKI within 30 days; 6. Known allergy to prescription or any component of the prescription used in this study; 7. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C) 8. Other reasons that are not suitable to participate in this study according to the researcher's judgment
References
Publications (0)
Data not yet available
No reference posted for this study.