pancreatic cancer
Conditions
Interventions
experimental group:1. Nimotuzumab:
Dosage:*400 mg, administered intravenously once a week (QW)
or 1600 mg divided into three doses, administered intravenously on days 1, 8, and 15 (600 mg + 600 mg + 400 mg), with a 28-day treatment cycle.
Preparation:Dissolve 8 vials (400 mg) of nimotuzumab
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Conversion Resection Rate;progression-free survival (PFS);Objective response rate (ORR);tumor-related markers;adverse events;Pathological Complete Response Rate (pCR);R0 Resection Rate;Tumor Marker Reduction Rate; Postoperative Complication Rate;Impact of Tumor-Related Biomarkers on Prognosis:KRAS Gene Status at Baseline,EGFR Protein Expression.These biomarkers will be evaluated to determine their correlation with treatment outcomes and overall prognosis in patients with locally advanced pancreatic cancer undergoing neoadjuvant therapy.; | — |
Countries
China
Contacts
Public ContactTaiping Zhang
Peking Union Medical College Hospital
Outcome results
None listed