Overview

This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.

Eligibility

Inclusion Criteria:

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

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

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

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4. Postoperative pathology suggested R0/R1 resection;

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5. EGFR positive (by immunohistochemistry);

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

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       7. Adequate organ and bone marrow function, defined as follows: absolute
          neutrophil 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) 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;

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8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

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9. Postoperative survival is expected to be ≥3 months;

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

Exclusion Criteria:

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

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       2. History of other malignancies (except cured basal cell carcinoma of the skin
          and carcinoma in situ of the cervix);

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       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;

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

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

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

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       7. Known HIV, 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.