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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Drug: Nimotuzumab. Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

Intervention public domain (ClinicalTrials.gov)

Drug: AG. Patients will receive nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1,000 mg/m\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

Arm public domain (ClinicalTrials.gov)

Nimotuzumab+ AG (experimental):

Primary outcome public domain (ClinicalTrials.gov)

disease-free survival (DFS). The time from the date of surgery to the disease recurrence or death, whichever is earlier. Time frame: Up to 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

distant metastasis-free survival (DMFS). Time frame: Up to 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

overall survival (OS). Time frame: Up to 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

tumor-related markers. Time frame: Up to 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

adverse events. Time frame: Up to 30 days after last administration.

Eligibility public domain (ClinicalTrials.gov)

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 \> 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\>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\. 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\>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\'s judgment.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 57 participants (estimated).