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Brief Title: Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Official Title: Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Single-arm, Phase II Trial
Study ID: NCT06389760
Brief Summary: This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer.
Detailed Description: This clinical study is designed as a prospective, multicenter, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), quality of life, tumor-related markers and safety.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
Name: Juan Du, MD
Affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Role: STUDY_CHAIR