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.
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;
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;
Single group
Nimotuzumab
DrugNimotuzumab 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.
AG
DrugPatients 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.
disease-free survival (DFS)
The time from the date of surgery to the disease recurrence or death, whichever is earlier.
distant metastasis-free survival (DMFS)
The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.
overall survival (OS)
The time from the date of surgery to death due to any cause.
tumor-related markers
To explore the influence of tumor-related markers (such as KRAS gene, CDX-2 protein, etc.) on prognosis.
adverse events
Frequency and severity of adverse events.
Click on the lead sponsor to view all of their trials.
