Nimotuzumab with nab-paclitaxel and gemcitabine for EGFR-positive pancreatic cancer

Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study

This study is testing if a new combination of Nimotuzumab with nab-paclitaxel and gemcitabine can help people with EGFR-positive pancreatic cancer live longer and stay cancer-free after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Provincial People's Hospital (Academic / other)
• Drugs / interventions: radiation, Nimotuzumab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06722911 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Nimotuzumab combined with nab-paclitaxel and gemcitabine as postoperative adjuvant therapy for patients with EGFR-positive pancreatic cancer. It is a prospective, open-label, single-arm phase II study focusing on disease-free survival as the primary endpoint. Additional endpoints include distant metastasis-free survival, overall survival, tumor-related markers, and safety assessments. The study aims to provide insights into the effectiveness of this combination therapy in improving patient outcomes after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resected EGFR-positive pancreatic ductal adenocarcinoma and no evidence of distant metastasis.

Not a fit: Patients with non-resectable pancreatic cancer or those who are not EGFR-positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival and overall outcomes for patients with EGFR-positive pancreatic cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating pancreatic cancer, indicating potential for success.

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 \> 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.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yiping Mou, Dr

Conditions Pancreatic Cancer Resectable