RecruitingPhase 2NCT06722911

Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in 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

Sponsor

Zhejiang Provincial People's Hospital

Enrollment

57 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding nimotuzumab (an antibody that targets a protein called EGFR) to standard chemotherapy (nab-paclitaxel and gemcitabine) can help prevent pancreatic cancer from coming back after surgery in patients whose tumors have high EGFR levels. **You may be eligible if...** - Age 18–75 - Had surgery to remove pancreatic ductal adenocarcinoma (a type of pancreatic cancer) - Tumor tested positive for EGFR overexpression - Recovered sufficiently from surgery - No signs of cancer remaining or spread after surgery - Able to perform daily activities without difficulty **You may NOT be eligible if...** - Cancer has spread to distant organs - Tumor does not overexpress EGFR - Have had prior chemotherapy or radiation for this cancer - Have serious heart, liver, kidney, or other organ problems - Are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.