Pancreatic Cancer Resectable
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGNimotuzumab
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.
DRUGAG
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.
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival (DFS) | Up to 24 months | The time from the date of surgery to the disease recurrence or death, whichever is earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| distant metastasis-free survival (DMFS) | Up to 24 months | The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier. |
| overall survival (OS) | Up to 24 months | The time from the date of surgery to death due to any cause. |
| tumor-related markers | Up to 24 months | To explore the influence of tumor-related markers (such as KRAS gene, CDX-2 protein, etc.) on prognosis. |
| adverse events | Up to 30 days after last administration | Frequency and severity of adverse events. |
Countries
China
Contacts
Primary ContactYiping Mou, Dr
Backup ContactTao Xia, Dr
Outcome results
None listed