Phase III Trial of Nimotuzumab Plus Paclitaxel as Second-Line Treatment for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma with EGFR Over-expression

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining nimotuzumab with paclitaxel as a second-line treatment for patients with recurrent metastatic gastric or esophagogastric junction adenocarcinoma that shows high EGFR expression. This phase III randomized, double-blind, placebo-controlled trial aims to compare overall survival between patients receiving nimotuzumab plus paclitaxel and those receiving placebo plus paclitaxel. The study will enroll 354 patients and also examine other outcomes like progression-free survival, response rates, and patient-reported outcomes. Participants will be randomly assigned to one of two groups the experimental group receives nimotuzumab injection starting with 600 mg then 400 mg weekly combined with paclitaxel at 80 mgm2 on days 1, 8, and 15 of each 4-week cycle the control group receives placebo with the same paclitaxel schedule. Treatment continues until the disease progresses, intolerance occurs, or the participant withdraws. Stratified block randomization will consider performance status, prior immunotherapy, and EGFR expression levels. The study includes an interim analysis and quality assurance procedures to ensure data integrity. During the trial, participants will undergo assessments including laboratory tests, physical exams, vital signs, electrocardiograms, imaging, and quality of life evaluations. Adverse events will be monitored from consent through 30 days after the last dose. Data will be collected electronically and reviewed for accuracy and completeness. The primary outcome is overall survival tracked until study completion, averaging 18 months, with secondary outcomes including progression-free survival, objective response rate, disease control rate, duration of response, patient-reported outcomes, and safety monitored for up to 12 months.

Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma