Status:
UNKNOWN
Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial
Lead Sponsor:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study is an double blind, randomized, multicenter phase 3 trial. The efficacy analyses are based on 570 Chinese patients with RAS wt mCRC treated with mFOLFOX-6 ± cetuximab. Study treatment contin...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Male or female subjects， 18-75 years of age
- Medically accepted effective contraception if procreative potential exists
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- RAS wild-type and BRAF-V600E wild-type status in tumor tissue
- At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
- White blood cell count \>= 3 × 10x9/L with neutrophils \>= 1.5 × 10x9/L, platelet count \>=75 × 10x9/L and hemoglobin \>= 8 g/dL； Total bilirubin \<= 1.5 × upper limit of reference range， Aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit of reference range or \<= 5 × upper reference range in subjects with liver metastasis；Serum creatinine \<= 1.5 × upper limit of reference range
Exclusion
- Known hypersensitivity or allergic reactions against any of the components of the trial treatments
- Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 28 days before trial treatment
- Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease，except the patient with fistulation or stenting
- Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
- Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram
- Renal replacement therapy
- Peripheral neuropathy \> grade 1
- History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
- Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Known severe coagulation disorders
- Previous chemotherapy for CRC except adjuvant treatment if terminated \> 12 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
- Previous treatment with anti-EGFR monoclonal antibody therapy
- Other non-permitted concomitant anticancer therapies, chronic systemic immune therapy or hormone therapy
- Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry，blood transfusion，or blood components transfusion
- Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
- Ongoing alcohol or drug abuse
- Known neurological or psychiatric diseases
- Participation in another clinical trial within the past 4 weeks
- Legal incapacity or limited legal capacity
- Other significant disease that in the investigator's opinion should exclude the subject from the trial
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT03426371
Start Date
February 1 2018
End Date
December 1 2023
Last Update
February 8 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
307 Hospital of PLA
Beijing, Beijing Municipality, China, 100071