Clinical Trial

Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

Study acronym: NOTABLE-308
Not Yet Recruiting Phase 3
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Summary
This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).
Trial Details
NCT Number NCT06343116
Lead Sponsor Biotech Pharmaceutical Co., Ltd.
Conditions Refractory Metastatic Colorectal Cancer
Enrollment 420 participants
Start Date 2024-04
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2024-04-02