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Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. Led by The First Affiliated Hospital with Nanjing Medical University and Peking University Cancer Hospital \& Institute (as leading centers), its main purpose is to evaluate the clinical efficacy and safety of Nimotuzumab combined with nab-paclitaxel plus gemcitabine (AG) in the perioperative treatment of high-risk resectable/borderline resectable pancreatic cancer.
Official title: Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2025-12-10
Completion Date
2029-12-10
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Nimotuzumab
Patients will receive 3 cycles of neoadjuvant treatment with Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant Nimotuzumab (400 mg on days 1, 8, and 15 of a 21-day cycle).
AG regimen
Patients will receive 3 cycles of AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant AG (gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2 on days 1 and 8 of a 21-day cycle).
Placebo
Patients will receive 3 cycles of neoadjuvant treatment with placebo (400 mg on days 1, 8, and 15 of a 21-day cycle), followed by surgery and 5 cycles of adjuvant therapy (placebo 400 mg on days 1, 8, and 15 of a 21-day cycle).
Locations (2)
Kuirong Jiang
Nanjing, Jiangsu, China
Chunyi Hao
Beijing, China