study of adjuvant nimotuzumab combined with nab-paclitaxel+ gemcitabine in egfr-positive pancreatic cancer

Conditions: Pancreatic Cancer Resectable

Summary: 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.

this clinical study is designed as a prospective, open-label, single arm, phase ii study to evaluate the clinical efficacy and safety of nimotuzumab combined with ag (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with egfr-positive pancreatic cancer. the main endpoint is disease-free survival (dfs). additional end points included distant metastasis-free survival (dmfs), overall survival (os), tumor-related markers and safety.

Eligibility criteria:
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 ductal adenocarcinoma (pdac), resectable evaluation is based on criteria of nccn guidelines, 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 (only for post hoc analysis); * 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 \&gt; 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 study period. exclusion criteria: * 1. prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma; * 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\&gt;160mmhg or dbp\&gt;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. 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; * 5. ca199\&gt;180 u/ml within 21d before adjuvant therapy; * 6. known allergy to prescription or any component of the prescription used in this study; * 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\&#39;s judgment.