Actively Recruiting
Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma
Led by Biotech Pharmaceutical Co., Ltd. · Updated on 2024-08-28
354
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In order to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel as second-line treatment for recurrent metastatic gastric or esophagogastric junction adenocarcinoma with EGFR over-expression, investigators performed a randomized, double-blind, placebo-controlled phase III clinical trial. Patients will be randomized (1:1) to receive nimotuzumab plus paclitaxel in the experimental group and placebo plus paclitaxel in the control group. The primary endpoint of this study was OS, and according to the results of the RAINBOW-Asia gastric cancer phase III clinical study, the mOS of paclitaxel single-agent second-line treatment for gastric cancer was 7.92 months, assuming that the mOS increased to 10.92 months after the addition of nimotuzumab, Using the survival module in the PASS15 software, the two-sided test level was set α=0.05, β=0.20, enrolled for 2 years, followed up for 1.5 years, the dropout rate was 5%, the sample size including interim analysis was 354 cases. The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient reported outcome (PRO), and safety.
CONDITIONS
Official Title
Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- ECOG performance status of 0 or 1
- Confirmed gastric or esophagogastric junction adenocarcinoma by pathology
- Recurrent metastatic disease after first-line chemotherapy or prior anti-HER2 or immunotherapy, with documented progression
- At least one measurable tumor lesion per RECIST 1.1
- EGFR high expression (IHC 2+ or 3+) in tumor tissue
- Estimated survival of 12 weeks or more
- Adequate organ function including specified limits for bilirubin, liver enzymes, creatinine, blood counts, and hemoglobin
- Willingness to use contraception if of childbearing age
- Negative pregnancy test within 72 hours prior to randomization for women of childbearing potential
- Ability to understand, comply with 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 within 4 weeks before randomization
- Participation in other therapeutic clinical trials or prohibited combined treatments within 4 weeks before randomization
- Major surgery, biopsy, or significant trauma within 4 weeks prior to randomization
- Brain or meningeal metastases
- History of other malignant tumors except cured cervical carcinoma in situ or skin basal cell carcinoma
- Severe bleeding disorders or vasculitis within 3 months before randomization
- Serious uncontrolled diseases including severe heart failure, unstable angina, uncontrolled arrhythmias, uncontrolled hypertension, uncontrolled diabetes, or mental illness affecting consent or compliance
- Allergies or contraindications to anti-EGFR antibodies, paclitaxel, or study components
- Unresolved severe adverse events from prior immune checkpoint inhibitors
- Uncontrolled large pleural effusion or ascites
- Grade 2-4 peripheral neuropathy
- Primary or secondary immunodeficiency
- Untreated or uncontrolled hepatitis B or C, positive syphilis or HIV infection, or uncontrolled infections
- Pregnancy, breastfeeding, or unwillingness to use reliable contraception during and up to 3 months after study
- Any condition that, in investigator's opinion, may compromise safety or study data reliability
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
xijuan Song
CONTACT
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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