Actively Recruiting
Nimotuzumab Combined With Paclitaxel as Second-line Treatment for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma With EGFR Over-expression: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial
Led by Biotech Pharmaceutical Co., Ltd. · Updated on 2024-08-28
354
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 mg/m2 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.
CONDITIONS
Brief Title
Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, male or female
- ECOG physical status score of 0 or 1
- Histologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma
- Recurrent metastatic disease with previous first-line standard chemotherapy or anti-HER2/immunotherapy treatment and confirmed disease progression
- At least one measurable tumor lesion according to RECIST version 1.1
- EGFR high expression (IHC 2+ or IHC 3+) in primary or metastatic lesion tissue
- Estimated survival of at least 12 weeks
- Adequate organ function including specified liver, kidney, blood counts, and hemoglobin levels
- Willingness of patients of childbearing age and their partners to use contraception
- Negative pregnancy test for women of potential fertility before randomization
- Ability to understand and agree to the study procedures and provide informed consent
You will not qualify if you...
- Disease progression after prior paclitaxel or anti-EGFR antibody treatment or treatment with these agents within 4 weeks before randomization
- Participation in other therapeutic clinical trials or prohibited combined treatments within 4 weeks before randomization
- Major surgery, incision biopsy, or traumatic injury within 4 weeks before randomization
- Brain or meningeal metastases
- History of malignant tumors other than gastric or esophagogastric junction adenocarcinoma (with some exceptions)
- Severe bleeding disorders or vasculitis within 3 months before randomization
- Serious diseases including refractory heart failure, unstable angina, uncontrolled arrhythmia or blood pressure, uncontrolled diabetes, or mental illness affecting consent or compliance
- Allergies or contraindications to study drugs
- Unresolved severe adverse events from previous immune checkpoint inhibitor therapy
- Uncontrolled third space effusion such as pleural effusion or ascites
- Moderate to severe peripheral neuropathy
- Primary or secondary immunodeficiency
- Untreated chronic hepatitis B or hepatitis C infection, positive for syphilis or HIV, or uncontrolled infections
- Pregnancy, breastfeeding, or unwillingness to use contraception during the study and specified follow-up period
- Any other condition that may negatively impact safety or study data reliability as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, intolerance, or withdrawal
Participants receive weekly nimotuzumab or placebo combined with paclitaxel administered on days 1, 8, and 15 of each 4-week cycle until disease progression, intolerance, or withdrawal from the trial.
Weekly visits for nimotuzumab or placebo dosing and visits on days 1, 8, and 15 of each 4-week cycle for paclitaxel administration
Duration - Up to study completion, an average of 18 months
Participants are followed up until death, loss to follow-up, or the end of the study to monitor overall survival and other outcomes.
Visits scheduled according to survival and progression assessments
Trial Site Locations
Total: 1 location
1
National Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
xijuan Song
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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