Actively Recruiting
Phase II Study of Nimotuzumab with Nab-paclitaxel and Gemcitabine as Postoperative Treatment for EGFR-positive Pancreatic Cancer
Led by Zhejiang Provincial People's Hospital · Updated on 2024-12-09
57
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Nimotuzumab with nab-paclitaxel and gemcitabine AG regimen as a postoperative adjuvant treatment for patients with EGFR-positive pancreatic cancer. This open-label, single-arm phase II study aims to assess the efficacy and safety of this combination, focusing on disease-free survival as the main outcome. Additional goals include evaluating distant metastasis-free survival, overall survival, tumor markers, and safety measures. Participants will receive Nimotuzumab doses of 400 mg on Days 1 and 15 in a 28-day cycle for six cycles, along with nab-paclitaxel 125 mgm and gemcitabine 1,000 mgm given intravenously on Days 1 and 8 of a 21-day cycle for six cycles. Treatment will continue unless imaging shows disease recurrence or unacceptable side effects occur. During the study, participants will undergo regular assessments including imaging to monitor disease status and blood tests to check tumor markers and safety. Researchers will track adverse events for 30 days after the last treatment and follow participants for up to 24 months to evaluate survival and disease progression. Total study duration includes these monitoring and treatment periods.
CONDITIONS
Brief Title
Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
Research Team
Y
Yiping Mou, Dr
T
Tao Xia, Dr
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