Stage IV Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.
Detailed description
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.
Interventions
DRUGNimotuzumab
400mg Q2W intravenously
DRUGPlacebo
Normal saline
Sponsors
Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology. * The sample size estimate: 20 cases per arm. * Males or females aged ≥18 years, \< 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks. * Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. * Adequate bone marrow, renal, and liver function are required. * Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
Exclusion criteria
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Allergy to anti-EGFR antibody. * Female subjects should not be pregnant or breast-feeding. * Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases. * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (Progression free survival) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 6 months |
| Overall survival (OS) | 12 months |
| Disease control rate (DCR) | 12 months |
Countries
China
Outcome results
None listed