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Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer.
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2024-05-01
Completion Date
2027-05-30
Last Updated
2024-05-10
Healthy Volunteers
No
Conditions
Interventions
Nimotuzumab
Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.
GX
Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 days' rest.
Placebo
Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China