This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of TC Regimenwith or without nimotuzumab in recurrent metastatic oral squamous cell carcinoma. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.
Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, China
RECRUITINGCompare Progression Free Survival (PFS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy using RECIST 1.1.
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Time frame: approximately 24 months
Compare objective response rate between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.
Time frame: approximately 24 months
Compare Overall Survival (OS) between Nimotuzumab + TC Regimen chemotherapy and TC Regimen chemotherapy
To compare the efficacy of the combination of Nimotuzumab plus TC Regimen chemotherapy versus TC Regimen chemotherapy in terms of overall survival (OS) in patients with recurrent metastatic oral squamous cell carcinoma. Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Time frame: approximately 24 months
Compare Disease Control Rate (DCR) between Nimotuzumab + TC Regimen and TC Regimen chemotherapy.
DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).
Time frame: approximately 24 months
Number of Participants who Experience Treatment Related Adverse Events (AEs).
All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. AEs graded using CTCAE (Version 4.0) criteria.
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Time frame: approximately 24 months