Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer

Inclusion Criteria:

1. Able and willing to provide a written informed consent.

2. Age 18-75 years old, gender unlimited;

3. Histologically or cytologically confirmed resected pancreatic ductaladenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCNguidelines, no evidence of distant metastasis as demonstrated by imaging;

4. Postoperative pathology suggested R0/R1 resection;

5. EGFR positive (by immunohistochemistry);

6. KRAS gene and CDX-2 protein status must have been determined at baseline (onlyfor post hoc analysis);

7. Adequate organ and bone marrow function, defined as follows: absoluteneutrophil count (ANC)≥1.5×10^9/L; platelets≥80×10^9/L; hemoglobin≥9.0 g/dL;serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) andalanine 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 is expected to be ≥3 months;

10. Fertile subjects are willing to take contraceptive measures during the studyperiod.

Exclusion Criteria:

1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy forpancreatic adenocarcinoma;

2. History of other malignancies (except cured basal cell carcinoma of the skinand 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, poorlycontrolled arrhythmias, uncontrolled hypertension (SBP>160mmHg orDBP>100mmHg); active infections; unmanageable diabetes mellitus; presence ofuncontrolled pleural effusion, pericardial effusion, or ascites requiringdrainage; severe portal hypertension; gastric outlet obstruction; Respiratoryinsufficiency;

4. Postoperative complications such as bleeding, pancreatic fistula, gastricobstruction, abdominal infection, and biliary fistula, which made the patientunable to receive adjuvant therapy within 12 weeks after surgery;

5. CA199>180 U/ml within 21d before adjuvant therapy;

6. Known allergy to prescription or any component of the prescription used in thisstudy;

7. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitisC);

• 8 .Other reasons that are not suitable to participate in this study according to theresearcher's judgment.