Spots Global Cancer Trial Database for Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
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Trial Identification
Brief Title: Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in 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
Study ID: NCT06409429
Conditions
Study Description
Brief 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.
Detailed Description: This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX (gemcitabine plus capecitabine) compared with GX only for resected pancreatic cancer. About 146 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus GX) and control group (placebo plus GX) at a ratio of 1:1. The main endpoint is relapse-free survival (RFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Contact Details
Name: Jihui Hao, Dr
Affiliation: Tianjin Medical University Cancer Institute and Hospital
Role: STUDY_CHAIR
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